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Influence of Bariatric Surgery on Serum Levels of 26RFa (RFa-Ba-S)

Primary Purpose

Diabetes, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Meal test taking and hormones measure including 26RFa
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes focused on measuring 26RFa, sleeve gastrectomy, diabetes, obesity

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers
  1. Patients :

    1. Inclusion Criteria:

      • Obese patients (with or without type 2 diabetes) with a planned sleeve gastrectomy
    2. Exclusion Criteria:

      • HbA1c >11 %.
  2. Healthy volunteers :

    1. Inclusion Criteria:

      • 20 ≤ BMI ≤ 25 kg/m²,
      • with no treatment that may influence the glycemic control,
      • normal electrocardiogram,
      • no disturbance of the following blood tests: CBC, serum electrolytes, glucose,
      • negative serology of HIV, hepatitis B and C,
      • does not participate at another clinical trial in the last 3 months
    2. Exclusion Criteria:

      • severe medical or surgical history, particularly endocrine or cardiac,
      • oedema syndrome,
      • hypertension.

Sites / Locations

  • University Hospital Rouen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Obese patients with type 2 diabetes

Obese patients witout diabetes

healthy volonteers

Arm Description

Meal test taking and hormones measure including 26RFa

Meal test taking and hormones measure including 26RFa

Meal test taking and hormones measure including 26RFa

Outcomes

Primary Outcome Measures

Serum 26RFa levels
Serum 26RFa levels will be measured in fasting conditions before a sleeve gastrectomy in obese patients with or without diabetes.

Secondary Outcome Measures

Kinetics of 26RFa levels during a test meal
levels of 26RFa levels will be measured during a meal test before and after a sleeve gastrectomy in obese patients with or without diabetes, and once a time in healthy volunteers.
kinetics of classical hormones implicated in glucose control and obesity
levels of classical hormones implicated in glucose control and obesity will be measured during a meal test before and after a sleeve gastrectomy in obese patients with or without diabetes, and once a time in healthy volunteers.
Levels of 26RFa and classical hormones implicated in glucose control and obesity just after a sleeve gastrectomy
Levels of 26RFa and classical hormones implicated in glucose control and obesity just after a sleeve gastrectomy (D3) in obese patients with or without diabetes.
score of satiety
Score satiety will be calculated using a questionary before and after a sleeve gastrectomy : once a time at D3, and at T0, T90 and T180 during a meal test at D30 and D180, in obese patients with or without diabetes. It will be also calculated in healthy volunteers at T0, T90 and T180 during a test meal.

Full Information

First Posted
October 16, 2013
Last Updated
June 26, 2020
Sponsor
University Hospital, Rouen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT01982019
Brief Title
Influence of Bariatric Surgery on Serum Levels of 26RFa
Acronym
RFa-Ba-S
Official Title
Determination of Serum Levels of the Orexigenic Neuropeptide 26RFa in Obese Female Patients With or Without Diabetes. Influence of Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 4, 2014 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The 26RFa was recently discovered in the hypothalamus. In rodents it seems to be related to glucose metabolism and obesity. However, no data exists in obese patients or in patients with diabetes. Thus, the investigators planned to dose 26RFa level in obese patients before and after a sleeve gastrectomy in order to study the effect of a weight loss on its levels. The investigators will also dose 26RFa concentrations in obese patients with type 2 diabetes and in healthy volunteers with normal weight. Comparison of these different groups will permit us to better understand the 26RFa involvement in glucose concentration regulation and in obesity.
Detailed Description
The 26RFa is an orexigenic neuropeptide of the Rfamides family, localized in two hypothalamic nuclei. Its increase induced obesity and it is elevated in obese rodents. In addition, in human, it is elevated in anorexic patients. However, no data exists in obese patients or in patients with diabetes. Thus, the investigators planned to measure 26RFa level in obese patients before and after a sleeve gastrectomy in order to study the effect of a weight loss on its levels. The investigators will also dose 26RFa concentrations in obese patients with type 2 diabetes and in healthy volunteers with normal weight. Comparison of these different groups will permit us to better understand the 26RFa involvement in glucose concentration regulation and in obesity. The investigators will also measure other hormones known to have a major role in glucose metabolism and obesity (ie. insulin, adiponectin). A meal test will be given to the volunteers in order to study the kinetics' of these molecules during and after food intake.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Obesity
Keywords
26RFa, sleeve gastrectomy, diabetes, obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obese patients with type 2 diabetes
Arm Type
Other
Arm Description
Meal test taking and hormones measure including 26RFa
Arm Title
Obese patients witout diabetes
Arm Type
Other
Arm Description
Meal test taking and hormones measure including 26RFa
Arm Title
healthy volonteers
Arm Type
Other
Arm Description
Meal test taking and hormones measure including 26RFa
Intervention Type
Behavioral
Intervention Name(s)
Meal test taking and hormones measure including 26RFa
Intervention Description
Meal test taking and blood sampling for the measure of 26RFa and classical hormones implicated in glucose control and obesity
Primary Outcome Measure Information:
Title
Serum 26RFa levels
Description
Serum 26RFa levels will be measured in fasting conditions before a sleeve gastrectomy in obese patients with or without diabetes.
Time Frame
About 1 month before a sleeve gastrectomy
Secondary Outcome Measure Information:
Title
Kinetics of 26RFa levels during a test meal
Description
levels of 26RFa levels will be measured during a meal test before and after a sleeve gastrectomy in obese patients with or without diabetes, and once a time in healthy volunteers.
Time Frame
Before (about 1 month) and after a sleeve gastrectomy (D30 and D180), during a test meal (T0, T30, T60, T90, T120, T150 and T180 )
Title
kinetics of classical hormones implicated in glucose control and obesity
Description
levels of classical hormones implicated in glucose control and obesity will be measured during a meal test before and after a sleeve gastrectomy in obese patients with or without diabetes, and once a time in healthy volunteers.
Time Frame
Before (about 1 month) and after a sleeve gastrectomy (D30 and D180), during a test meal (T0, T30, T60, T90, T120, T150 and T180 )
Title
Levels of 26RFa and classical hormones implicated in glucose control and obesity just after a sleeve gastrectomy
Description
Levels of 26RFa and classical hormones implicated in glucose control and obesity just after a sleeve gastrectomy (D3) in obese patients with or without diabetes.
Time Frame
at D3 after a sleeve gastrectomy
Title
score of satiety
Description
Score satiety will be calculated using a questionary before and after a sleeve gastrectomy : once a time at D3, and at T0, T90 and T180 during a meal test at D30 and D180, in obese patients with or without diabetes. It will be also calculated in healthy volunteers at T0, T90 and T180 during a test meal.
Time Frame
Before (about 1 month) and after a sleeve gastrectomy (D3, D30 and D180)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients : Inclusion Criteria: Obese patients (with or without type 2 diabetes) with a planned sleeve gastrectomy Exclusion Criteria: HbA1c >11 %. Healthy volunteers : Inclusion Criteria: 20 ≤ BMI ≤ 25 kg/m², with no treatment that may influence the glycemic control, normal electrocardiogram, no disturbance of the following blood tests: CBC, serum electrolytes, glucose, negative serology of HIV, hepatitis B and C, does not participate at another clinical trial in the last 3 months Exclusion Criteria: severe medical or surgical history, particularly endocrine or cardiac, oedema syndrome, hypertension.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaëtan Prevost, MD
Organizational Affiliation
University Hospital, Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Rouen
City
Rouen
State/Province
Haute Normandie
ZIP/Postal Code
76000
Country
France

12. IPD Sharing Statement

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Influence of Bariatric Surgery on Serum Levels of 26RFa

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