Role of GLP-1 in Hyperinsulinemic Hypoglycemia Post-bariatric Surgery
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02550145|
Recruitment Status : Unknown
Verified April 2016 by Tracey McLaughlin, Stanford University.
Recruitment status was: Recruiting
First Posted : September 15, 2015
Last Update Posted : July 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hypoglycemia||Drug: Exendin (9-39) Other: Placebo||Phase 1|
The physiologic mechanisms mediating the glucose-lowering effect of Roux-en-Y Gastric Bypass (RYGB) or post-Vertical Sleeve Gastrectomy (VSG) are unknown. The reduction in glucose excursions prior to weight loss has lead to postulates that the incretin hormone, GLP-1, may play an important role.
The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions in a subset of post-bariatric patients through the pharmacologic blockade of the GLP-1 receptor in post-RYGB or post-VSG patients with severe symptomatic hypoglycemia.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||The Role of GLP-1 in Mediating Glucose Reductions After Bariatric Surgery|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||December 2016|
IV infusion of Exendin (9-39).
Drug: Exendin (9-39)
IV infusion of Exendin (9-39) during standardized oral glucose tolerance test (OGTT).
Placebo Comparator: Placebo
IV infusion of normal saline
IV infusion of Placebo (normal saline) during standardized oral glucose tolerance test (OGTT)
- Plasma glucose area under the curve [ Time Frame: 0 to 180 minutes ]
- Plasma insulin area under the curve [ Time Frame: 0 to 180 minutes ]
- Hypoglycemia symptom score [ Time Frame: 0-180 minutes ]
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): NCT02550145
|Contact: Colleen Craig, M.D.||firstname.lastname@example.org|
|Contact: Tracey McLaughlin, M.D.|
|United States, California|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Colleen Craig, M.D. 650-350-2153 email@example.com|
|Study Director:||Colleen Craig, M.D.||Stanford University|