Clinical trial NCT01803451: Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass
Official title: The Role of Glucagon Like Peptide-1 in Glucose Metabolism and Weight Loss Following Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Post-bariatric Surgery
Keywords: gastric bypass
glucose metabolism
hypoglycemia
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2013-03-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: up to 1 year (10 sessions)
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Texas Diabetes Institute - University Health System
state: Texas
city: San Antonio
country: United States
facility: South Texas Veterans Health Care System
state: Texas
Study officials:
affiliation: Marzieh Salehi
name: Marzieh Salehi, MD,MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.