Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass
NCT ID: NCT01803451
Last Updated: 2025-09-09
Study Results
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Basic Information
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RECRUITING
EARLY_PHASE1
80 participants
INTERVENTIONAL
2005-11-30
2027-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
OTHER
SINGLE
Study Groups
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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
exendin-(9-39)
hyperglycemic clamp-meal tolerance test is designed to assess insulin secretion before and after meal ingestion
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
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.
Interventions
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exendin-(9-39)
hyperglycemic clamp-meal tolerance test is designed to assess insulin secretion before and after meal ingestion
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* healthy control without diabetes or active organ disease
* Individuals with bariatric surgery
* recurrent hypoglycemia post gastric bypass
Exclusion Criteria
* significant anemia
* diabetes currently unless pre-op for bariatric surgery procedure
* GI obstruction
18 Years
65 Years
ALL
Yes
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Marzieh Salehi, MD,MS
Role: PRINCIPAL_INVESTIGATOR
Marzieh Salehi
Locations
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Texas Diabetes Institute - University Health System
San Antonio, Texas, United States
South Texas Veterans Health Care System
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Salehi M, Gastaldelli A, D'Alessio DA. Blockade of glucagon-like peptide 1 receptor corrects postprandial hypoglycemia after gastric bypass. Gastroenterology. 2014 Mar;146(3):669-680.e2. doi: 10.1053/j.gastro.2013.11.044. Epub 2013 Dec 4.
Other Identifiers
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DK083554
Identifier Type: OTHER
Identifier Source: secondary_id
HSC20180070H
Identifier Type: -
Identifier Source: org_study_id
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