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The Effects of Bariatric Surgeries on Glucose Metabolism

Primary Purpose

Post Bariatric Surgery, Gastric Bypass, Sleeve Gastrectomy

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Exendin-(9-39)
Atropine
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Bariatric Surgery focused on measuring gastric bypass surgery, Hypoglycemia, sleeve gastrectomy, glucose tolerance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Hypoglycemic RYGB patients with documented blood glucose level <50 mg/dl
  • Asymptomatic individuals with bariatric surgery
  • Healthy non-surgical patients with no personal history of diabetes
  • Subjects must physically be able to come to our clinical research center Cedars-Sinai Medical Center

Exclusion Criteria:

  • Active heart, lung, liver, gastrointestinal or kidney disease; unable to give informed consent; pregnancy; uncontrolled high blood pressure or high cholesterol; significant anemia (hemoglobin <11g/dL); prisoners or institutionalized individuals; type 2 diabetes mellitis; development of any serious medical or psychiatric illness during recruitment or studies;
  • RYGB patients will be disqualified if they have gastric outlet obstruction or severe diarrhea.
  • Healthy non-surgical patients with personal history of diabetes

For administration of atropine, the following exclusions also apply:

  • History of glaucoma
  • Uncontrolled hypertension (any subjects with BP>140/90 and history of dyslipidemia
  • Taking any medication that might interact with atropine and cannot be stopped will be excluded from the study)
  • Myasthenia gravis
  • Brain pathology
  • Enlarged prostate in men

Sites / Locations

  • Texas Diabetes Institute - University Health SystemRecruiting
  • South Texas Veterans Health Care SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exendin-(9-39)

Atropine

Arm Description

To evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.

to evaluate the effect of neural activation on insulin secretion and glucose metabolism

Outcomes

Primary Outcome Measures

Insulin levels measured after nutrient ingestion

Secondary Outcome Measures

Full Information

First Posted
October 22, 2015
Last Updated
August 21, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02823665
Brief Title
The Effects of Bariatric Surgeries on Glucose Metabolism
Official Title
The Effects of Bariatric Surgeries on Glucose Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is learn the effect of gastric bypass surgery and sleeve gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after eating.
Detailed Description
The purpose of this study is to determine the weight-independent effects of gastric bypass surgery and sleeve gastrectomy surgery on islet cell response after meal ingestion as mediated by hormonal and neural components of the gut. It will also address the differences between the two procedures. Such information will be critical for the development of novel approaches for treatment of diabetes as well as improvement of glycemic effects of gastric bypass and sleeve gastrectomy in patients with partial diabetes remission or relapse after complete remission.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Bariatric Surgery, Gastric Bypass, Sleeve Gastrectomy, Hypoglycemia After Gastric Bypass
Keywords
gastric bypass surgery, Hypoglycemia, sleeve gastrectomy, glucose tolerance

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exendin-(9-39)
Arm Type
Experimental
Arm Description
To evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.
Arm Title
Atropine
Arm Type
Experimental
Arm Description
to evaluate the effect of neural activation on insulin secretion and glucose metabolism
Intervention Type
Drug
Intervention Name(s)
Exendin-(9-39)
Other Intervention Name(s)
no other name for Exendin-(9-39)
Intervention Description
A physiological study to evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.
Intervention Type
Drug
Intervention Name(s)
Atropine
Other Intervention Name(s)
Atropine sulfate
Intervention Description
A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism.
Primary Outcome Measure Information:
Title
Insulin levels measured after nutrient ingestion
Time Frame
Each study in the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hypoglycemic RYGB patients with documented blood glucose level <50 mg/dl Asymptomatic individuals with bariatric surgery Healthy non-surgical patients with no personal history of diabetes Subjects must physically be able to come to our clinical research center Cedars-Sinai Medical Center Exclusion Criteria: Active heart, lung, liver, gastrointestinal or kidney disease; unable to give informed consent; pregnancy; uncontrolled high blood pressure or high cholesterol; significant anemia (hemoglobin <11g/dL); prisoners or institutionalized individuals; type 2 diabetes mellitis; development of any serious medical or psychiatric illness during recruitment or studies; RYGB patients will be disqualified if they have gastric outlet obstruction or severe diarrhea. Healthy non-surgical patients with personal history of diabetes For administration of atropine, the following exclusions also apply: History of glaucoma Uncontrolled hypertension (any subjects with BP>140/90 and history of dyslipidemia Taking any medication that might interact with atropine and cannot be stopped will be excluded from the study) Myasthenia gravis Brain pathology Enlarged prostate in men
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marzieh Salehi, MD MS
Phone
210-567-6691
Email
salehi@uthscsa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Hansis-Diarte
Phone
210-567-6691
Email
hansisdiarte@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marzieh Salehi, MD, MS
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Diabetes Institute - University Health System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Hansis-Diarte, MPh
Phone
210-567-3208
Email
hansisdiarte@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Marzieh Salehi, MD
Facility Name
South Texas Veterans Health Care System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Hansis-Diarte
Phone
210-567-6691
Email
hansisdiarte@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Marzieh Salehi, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Bariatric Surgeries on Glucose Metabolism

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