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

The University of Texas System (UT)

Status and phase: Enrolling; Early Phase 1

Conditions: Post-bariatric Surgery

Treatments: Drug: exendin -(9-39); Drug: exendin-(9-39)

Study type: Interventional

Funder types: Other

Identifiers

NCT01803451

HSC20180070H

DK083554 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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80 participants in 2 patient groups

hyperglycemic clamp-Meal tolerance test

Experimental group

Description:

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

Treatment:

Drug: exendin-(9-39)

Labeled meal tolerance test

Experimental group

Description:

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

Treatment:

Drug: exendin -(9-39)