ClinicalTrials.gov
ClinicalTrials.gov Menu

Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass (GLP-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01803451
Recruitment Status : Recruiting
First Posted : March 4, 2013
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:

The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism.

The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins that improve insulin secretion and glucose metabolism. The study is divided into three specific aims.

  1. To determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp.
  2. To compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals.
  3. To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.

Condition or disease Intervention/treatment Phase
Post-bariatric Surgery Drug: exendin-(9-39) Drug: exendin -(9-39) Early Phase 1

Detailed Description:

The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism.

The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins that improve insulin secretion and glucose metabolism. The study is divided into three specific aims.

  1. To determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp.
  2. To compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals.
  3. To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The Role of Glucagon Like Peptide-1 in Glucose Metabolism and Weight Loss Following Gastric Bypass Surgery
Study Start Date : November 2005
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: hyperglycemic clamp-Meal tolerance test
these studies are to evaluate the effect of exendin-9 on insulin secretion before and after meal ingestion in patients after bariatric surgeries compared to non-surgical controls
Drug: exendin-(9-39)
hyperglycemic clamp-meal tolerance test is designed to assess insulin secretion before and after meal ingestion
Other Name: no other name for exendin-(9-39)
Experimental: Labeled meal tolerance test
The effect of GLP-1 receptor blockade on glucose tolerance and glucose kinetics are evaluated in the group patients with bariatric surgery vs. nonsurgical using exendin-9-39 infusion during one of the the 2-day dual tracer studies of meal tolerance test
Drug: exendin -(9-39)
2-day meal tolerance tests with labeled oral and IV glucose using exendin-(9-39) infusion are designed to evaluate the role of GLP-1 signaling on glucose tolerance and glucose kinetics.
Other Name: no other name for exendin-(9-39)



Primary Outcome Measures :
  1. The investigator measure glucose, islet and GI hormonal levels in response to meal ingestion as a composite measure and the percentage of contribution of GLP-1 contribution to postprandial insulin levels will also be calculated [ Time Frame: up to 1 year (10 sessions) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18-65
  • healthy control without diabetes or active organ disease
  • Individuals with bariatric surgery
  • recurrent hypoglycemia post gastric bypass

Exclusion Criteria:

  • pregnancy
  • significant anemia
  • diabetes currently unless pre-op for bariatric surgery procedure
  • GI obstruction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803451


Contacts
Contact: Marzieh Salehi, MD MS 210-567-6691 salehi@uthscsa.edu
Contact: Andrea Hansis-Diarte 210-567-6691 HansisDiarte@uthscsa.edu

Locations
United States, Texas
South Texas Veterans Health Care System Recruiting
San Antonio, Texas, United States, 78229
Contact: Marzieh Salehi, MD MS    210-567-6691    salehi@uthscsa.edu   
Contact: Andrea Hansis-Diarte    210-567-6691    HansisDiarte@uthscsa.edu   
Principal Investigator: Marzieh Salehi, MD         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Marzieh Salehi, MD,MS Marzieh Salehi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01803451     History of Changes
Other Study ID Numbers: HSC20180070H
DK083554 ( Other Identifier: NIDDK )
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Keywords provided by The University of Texas Health Science Center at San Antonio:
gastric bypass
glucose metabolism
hypoglycemia

Additional relevant MeSH terms:
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins