A Dose-response of the Effects of Exendin-9,39 on GI Symptoms and Food Intake

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Diabetes; Obesity; Roux-en-Y Gastric Bypass

Treatments: Other: Saline; Drug: Exendin-9,39

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02128581

UL1RR024150 (U.S. NIH Grant/Contract)

R01DK082396 (U.S. NIH Grant/Contract)

14-002150

Details and patient eligibility

About

Exendin-(9,39) has been shown to have effects on beta-cell function, and after gastric bypass, to accelerate gastrointestinal transit. - infused at rates of 300pmol/kg/min. Given that gastrointestinal transit is typically delayed by Glucagon-Like Peptide-1 (GLP-1) and also that this hormone causes decreased food intake through increased satiation, it is reasonable to expect an effect of Exendin-9,39 on appetite. This may help explain the effects of gastric bypass on food intake. To examine the effect of Exendin on food intake we propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion. We will examine the presence of gastrointestinal symptoms as well as food intake in the immediate aftermath of a test meal and the subsequent hours.

Enrollment: 3 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have undergone Roux en-Y Gastric Bypass at least 6 months prior to enrollment in the study.
• Subjects without active systemic illness.

Exclusion criteria

• Subjects <20 years of age will not be studied to minimize the possibility of type 1 diabetes.
• Subjects >70 years of age will not be studied to minimize the potential confounding effects of age on glucose tolerance.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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3 participants in 3 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

a saline infusion will be started and maintained till the end of the study at 1300 (300 minutes).

Treatment:

Other: Saline

Exendin-9,39 @ 300

Active Comparator group

Description:

Exendin-9,39 @ 300pmol/kg/min

Treatment:

Drug: Exendin-9,39

Exendin-9,39 @ 750

Active Comparator group

Description:

Exendin-9,39 @ 750pmol/kg/min

Treatment:

Drug: Exendin-9,39