Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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

This trial accepts healthy volunteers

Qualifiers

age 18-65

healthy control without diabetes or active organ disease

Individuals with bariatric surgery

recurrent hypoglycemia post gastric bypass

Disqualifiers

pregnancy

significant anemia

diabetes currently unless pre-op for bariatric surgery procedure

GI obstruction

Trial design

Design model

Factorial

Treatments tested in this trial

  • exendin-(9-39)

    Drug

    hyperglycemic clamp-meal tolerance test is designed to assess insulin secretion before and after meal ingestion

  • exendin -(9-39)

    Drug

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: hyperglycemic clamp-Meal tolerance testExperimental treatment 1 intervention
Group B: Labeled meal tolerance testExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

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