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Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission

Primary Purpose

Obesity, Diabetes, Bariatric Surgery

Status
Active
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Oxytocin
placebo
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-65
  • Diabetes Mellitus type 2
  • HBA1C < or= 9
  • BMI >35
  • eligible for bariatric surgery (after a hospital bariatric committee)
  • Advanced diarem>6
  • Signed an informed consent -

Exclusion Criteria:

  • HBA1C above 9
  • Prior bariatric surgery in the past 6 years
  • secondary diabetes
  • steroid therapy
  • uncontrolled hypertension(>180/100)
  • Arythmia: paroxysmal tachyarythmia or high degree AV-Block

Sites / Locations

  • Soroka Unuversity Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

oxytocin

placebo

Arm Description

8 U/oxytocin three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks

intranasal spray containing placebo three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks

Outcomes

Primary Outcome Measures

Number of participants with diabetes remission 1 year post surgery
HBA1C less then 6.5% without need for diabetes medication
Number of participants who improved their glycemic control
increase in "Time in Range" by 10% and or decrease in HBA1C by 1 % 8 weeks from treatment
weight loss
weight reduction - kg.
weight loss
weight reduction - kg.
obesity
change in waist circumference
obesity
change in waist circumference

Secondary Outcome Measures

Rate of Insulin secretion
Increase of insulin secretion after oxytocin administration
Rate of Insulin secretion
Increase of insulin secretion after oxytocin administration
Rate of insulin resistance
Increase of insulin sensitivity after oxytocin administration
Rate of insulin resistance
Increase of insulin sensitivity after oxytocin administration
lipids-LDL CHOLESTEROL
change in lipid profile: LDL
lipids-LDL CHOLESTEROL
change in lipid profile: LDL
lipids-HDL CHOLESTEROL
change in lipid profile: HDL
lipids-HDL CHOLESTEROL
change in lipid profile: HDL
lipids-NON HDL CHOLESTEROL
change in lipid profile: NON HDL cholesterol. triglycerides
lipids-NON HDL CHOLESTEROL
change in lipid profile: NON HDL cholesterol. triglycerides
lipids-Triglycerides
change in lipid profile: triglycerides
lipids-Triglycerides
change in lipid profile: triglycerides
blood pressure
change in systolic and diastolic blood pressure
blood pressure
change in systolic and diastolic blood pressure
urine microalbumin
Change in microalbumin/creatinin
urine microalbumin
Change in microalbumin/creatinin
HPA axis
change in cortisol
HPA axis
change in cortisol
HPA axis
change in ACTH
HPA axis
change in ACTH
systemic inflammation
changes of inflammation markers: hrCRP
systemic inflammation
changes of inflammation markers: hrCRP
systemic inflammation
changes of inflammation markers: IL-6
systemic inflammation
changes of inflammation markers: IL-6
systemic inflammation
changes of inflammation markers: TNFα
systemic inflammation
changes of inflammation markers: TNFα
systemic inflammation
changes of inflammation markers: IL-1α
systemic inflammation
changes of inflammation markers: IL-1α
systemic inflammation
changes of inflammation markers: IL-1RA
systemic inflammation
changes of inflammation markers: IL-1RA
systemic inflammation
changes of inflammation markers: IL-17
systemic inflammation
changes of inflammation markers: IL-17
systemic inflammation
changes of inflammation markers: IL-21
systemic inflammation
changes of inflammation markers: IL-21
systemic inflammation
changes of inflammation markers: adiponectin
systemic inflammation
changes of inflammation markers: adiponectin
systemic inflammation
changes of inflammation markers: leptin
systemic inflammation
changes of inflammation markers:leptin
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: E2F1
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ASK1/2
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: LC3-II
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: family of ATGs
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:p-62
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TRAL
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TL-1A
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CCL5
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:RB1
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:LEPTIN.
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CCL2,
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CCL8
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CD68
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: BECN1
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TFDP1
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ADIPOQ,
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: NCK2
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TP53
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: COL6A1
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: COL3A1
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: KIT
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CMA1
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: RIPK1
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:TNF
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD36
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: IL-6
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ELN
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD11C
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CD206
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD163
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD209
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CTGF
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: PEPD
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: PAI-1
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: BCKDHB
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:HADHA
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: MMUT
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ALDH6A1
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: endogenous control-PGK1
omental and subcutaneous fat inflammation
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: endogenous control PPIA
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: E2F1
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: ASK1
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: p-62
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: TRAL
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: TL-1A,
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: PEPD
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: PAI-1
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: family of ATGs
omental and subcutaneous fat inflammation
Western blot analysis -The following proteins will be evaluated: endogenous control -beta-actin
omental and subcutaneous fat inflammation
ELISA: adiponectin
omental and subcutaneous fat inflammation
ELISA: leptin
omental and subcutaneous fat inflammation
ELISA: TNF
omental and subcutaneous fat inflammation
ELISA: IL-6
omental and subcutaneous fat inflammation
histological studies :Adipocyte size distribution.
omental and subcutaneous fat inflammation
histological studies : CD68 staining
omental and subcutaneous fat inflammation
histological studies :,c-kit staining
omental and subcutaneous fat inflammation
Culture of explants in media for up to 1 week for obtaining medium with secreted products of the tissue. Following secreted products will be measured using ELISA: adiponectin
omental and subcutaneous fat inflammation
Culture of explants in media for up to 1 week for obtaining medium with secreted products of the tissue. Following secreted products will be measured using ELISA: leptin
omental and subcutaneous fat inflammation
Culture of explants in media for up to 1 week for obtaining medium with secreted products of the tissue. Following secreted products will be measured using ELISA: TNF
omental and subcutaneous fat inflammation
Culture of explants in media for up to 1 week for obtaining medium with secreted products of the tissue. Following secreted products will be measured using ELISA: IL-6
omental and subcutaneous fat inflammation
Culture of explants in media for up to 1 week for obtaining medium with secreted products of the tissue. Following secreted products will be measured using ELISA: CTRP6/12/2 (ng/ml).

Full Information

First Posted
October 23, 2019
Last Updated
January 12, 2022
Sponsor
Soroka University Medical Center
Collaborators
Ben-Gurion University of the Negev
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1. Study Identification

Unique Protocol Identification Number
NCT05207774
Brief Title
Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission
Official Title
Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes remissionPre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soroka University Medical Center
Collaborators
Ben-Gurion University of the Negev

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in obese adults with diabetes undergoing bariatric surgery. Subjects will be randomized to receive of intranasal oxytocin or placebo (8 units 3 times daily) for 8 weeks prior surgery. Study visits include screening to determine eligibility, CGM will be connected before and after oxytocin administration, and 1 year post surgery. blood tests including oral glucose tolerance test will be done and fat samples will be taken during surgery. The investigator's hypothesis is that oxytocin administration prior bariatric surgery can induce diabetes remission in patients with diabetes

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes, Bariatric Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oxytocin
Arm Type
Experimental
Arm Description
8 U/oxytocin three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
intranasal spray containing placebo three-times daily, 30 min before breakfast, lunch and dinner, using a nasal atomizer for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
8 weeks intranasal oxytocin 24 units per day. 8 units prior each meal. 4units/0.1 ml per puff
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
8 weeks intranasal placebo 0.6 ml per day. . 0.1 ml per puff
Primary Outcome Measure Information:
Title
Number of participants with diabetes remission 1 year post surgery
Description
HBA1C less then 6.5% without need for diabetes medication
Time Frame
1 year post surgery
Title
Number of participants who improved their glycemic control
Description
increase in "Time in Range" by 10% and or decrease in HBA1C by 1 % 8 weeks from treatment
Time Frame
8 weeks
Title
weight loss
Description
weight reduction - kg.
Time Frame
8 weeks
Title
weight loss
Description
weight reduction - kg.
Time Frame
1 year
Title
obesity
Description
change in waist circumference
Time Frame
8 weeks
Title
obesity
Description
change in waist circumference
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Rate of Insulin secretion
Description
Increase of insulin secretion after oxytocin administration
Time Frame
8 weeks
Title
Rate of Insulin secretion
Description
Increase of insulin secretion after oxytocin administration
Time Frame
1 year
Title
Rate of insulin resistance
Description
Increase of insulin sensitivity after oxytocin administration
Time Frame
8 weeks
Title
Rate of insulin resistance
Description
Increase of insulin sensitivity after oxytocin administration
Time Frame
1 year
Title
lipids-LDL CHOLESTEROL
Description
change in lipid profile: LDL
Time Frame
8 weeks
Title
lipids-LDL CHOLESTEROL
Description
change in lipid profile: LDL
Time Frame
1 year
Title
lipids-HDL CHOLESTEROL
Description
change in lipid profile: HDL
Time Frame
8 weeks
Title
lipids-HDL CHOLESTEROL
Description
change in lipid profile: HDL
Time Frame
1 year
Title
lipids-NON HDL CHOLESTEROL
Description
change in lipid profile: NON HDL cholesterol. triglycerides
Time Frame
8 weeks
Title
lipids-NON HDL CHOLESTEROL
Description
change in lipid profile: NON HDL cholesterol. triglycerides
Time Frame
1 year
Title
lipids-Triglycerides
Description
change in lipid profile: triglycerides
Time Frame
8 weeks
Title
lipids-Triglycerides
Description
change in lipid profile: triglycerides
Time Frame
1 year
Title
blood pressure
Description
change in systolic and diastolic blood pressure
Time Frame
8 weeks
Title
blood pressure
Description
change in systolic and diastolic blood pressure
Time Frame
1 year
Title
urine microalbumin
Description
Change in microalbumin/creatinin
Time Frame
8 weeks
Title
urine microalbumin
Description
Change in microalbumin/creatinin
Time Frame
1 year
Title
HPA axis
Description
change in cortisol
Time Frame
8 weeks
Title
HPA axis
Description
change in cortisol
Time Frame
1 year
Title
HPA axis
Description
change in ACTH
Time Frame
8 weeks
Title
HPA axis
Description
change in ACTH
Time Frame
1 year
Title
systemic inflammation
Description
changes of inflammation markers: hrCRP
Time Frame
8 weeks
Title
systemic inflammation
Description
changes of inflammation markers: hrCRP
Time Frame
1 year
Title
systemic inflammation
Description
changes of inflammation markers: IL-6
Time Frame
8 weeks
Title
systemic inflammation
Description
changes of inflammation markers: IL-6
Time Frame
1 year
Title
systemic inflammation
Description
changes of inflammation markers: TNFα
Time Frame
8 weeks
Title
systemic inflammation
Description
changes of inflammation markers: TNFα
Time Frame
1 year
Title
systemic inflammation
Description
changes of inflammation markers: IL-1α
Time Frame
8 weeks
Title
systemic inflammation
Description
changes of inflammation markers: IL-1α
Time Frame
1 year
Title
systemic inflammation
Description
changes of inflammation markers: IL-1RA
Time Frame
8 weeks
Title
systemic inflammation
Description
changes of inflammation markers: IL-1RA
Time Frame
1 year
Title
systemic inflammation
Description
changes of inflammation markers: IL-17
Time Frame
8 weeks
Title
systemic inflammation
Description
changes of inflammation markers: IL-17
Time Frame
1 year
Title
systemic inflammation
Description
changes of inflammation markers: IL-21
Time Frame
8 weeks
Title
systemic inflammation
Description
changes of inflammation markers: IL-21
Time Frame
1 year
Title
systemic inflammation
Description
changes of inflammation markers: adiponectin
Time Frame
8 weeks
Title
systemic inflammation
Description
changes of inflammation markers: adiponectin
Time Frame
1 year
Title
systemic inflammation
Description
changes of inflammation markers: leptin
Time Frame
8 weeks
Title
systemic inflammation
Description
changes of inflammation markers:leptin
Time Frame
1 year
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: E2F1
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ASK1/2
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: LC3-II
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: family of ATGs
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:p-62
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TRAL
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TL-1A
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CCL5
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:RB1
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:LEPTIN.
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CCL2,
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CCL8
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CD68
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: BECN1
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TFDP1
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ADIPOQ,
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: NCK2
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: TP53
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: COL6A1
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: COL3A1
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: KIT
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CMA1
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: RIPK1
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:TNF
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD36
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: IL-6
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ELN
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD11C
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:CD206
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD163
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CD209
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: CTGF
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: PEPD
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: PAI-1
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: BCKDHB
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated:HADHA
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: MMUT
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: ALDH6A1
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: endogenous control-PGK1
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Real time PCR - mRNA will be extracted, cDNA will be generated and the following genes will be evaluated: endogenous control PPIA
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Western blot analysis -The following proteins will be evaluated: E2F1
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Western blot analysis -The following proteins will be evaluated: ASK1
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Western blot analysis -The following proteins will be evaluated: p-62
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Western blot analysis -The following proteins will be evaluated: TRAL
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Western blot analysis -The following proteins will be evaluated: TL-1A,
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Western blot analysis -The following proteins will be evaluated: PEPD
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Western blot analysis -The following proteins will be evaluated: PAI-1
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Western blot analysis -The following proteins will be evaluated: family of ATGs
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Western blot analysis -The following proteins will be evaluated: endogenous control -beta-actin
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
ELISA: adiponectin
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
ELISA: leptin
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
ELISA: TNF
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
ELISA: IL-6
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
histological studies :Adipocyte size distribution.
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
histological studies : CD68 staining
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
histological studies :,c-kit staining
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Culture of explants in media for up to 1 week for obtaining medium with secreted products of the tissue. Following secreted products will be measured using ELISA: adiponectin
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Culture of explants in media for up to 1 week for obtaining medium with secreted products of the tissue. Following secreted products will be measured using ELISA: leptin
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Culture of explants in media for up to 1 week for obtaining medium with secreted products of the tissue. Following secreted products will be measured using ELISA: TNF
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Culture of explants in media for up to 1 week for obtaining medium with secreted products of the tissue. Following secreted products will be measured using ELISA: IL-6
Time Frame
8 weeks
Title
omental and subcutaneous fat inflammation
Description
Culture of explants in media for up to 1 week for obtaining medium with secreted products of the tissue. Following secreted products will be measured using ELISA: CTRP6/12/2 (ng/ml).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65 Diabetes Mellitus type 2 HBA1C < or= 9 BMI >35 eligible for bariatric surgery (after a hospital bariatric committee) Advanced diarem>6 Signed an informed consent - Exclusion Criteria: HBA1C above 9 Prior bariatric surgery in the past 6 years secondary diabetes steroid therapy uncontrolled hypertension(>180/100) Arythmia: paroxysmal tachyarythmia or high degree AV-Block
Facility Information:
Facility Name
Soroka Unuversity Medical Center
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Pre-operative Intranasal Oxytocin for Enhancing Bariatric-induced Diabetes Remission

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