The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass

Adrian Vella

Status and phase: Completed; Early Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Exendin 9, 39

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01843881

11-007667

UL1RR024150 (U.S. NIH Grant/Contract)

R01DK082396 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The study is being undertaken to understand how the Roux-en-Y Gastric Bypass procedure can affect insulin secretion after meals. The hypothesis of this study is the Disposition Index is decreased in subjects who had previously undergone Roux-en-Y Gastric Bypass by glucagon-like peptide-1 (GLP-1) receptor blockade.

Enrollment: 20 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Roux-en-Y Gastric Bypass (RYGB)Subjects:

• Subjects who have undergone RYGB

Inclusion Criteria Healthy Subjects:

• Must match RYGB subjects in age, weight, and gender
• Subjects will be without active systemic illness

Exclusion Criteria all Subjects:

• Subjects <20 years old and >70 years old
• For Female Subjects: positive pregnancy text at the time of enrollment or study
• Subjects with functional or organic bowel symptoms.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Exendin 9, 39

Experimental group

Description:

Exendin 9, 39 will be infused at 300pmol/kg/min in either first intervention period or second intervention period.

Treatment:

Drug: Exendin 9, 39

Placebo

Placebo Comparator group

Description:

A saline infusion will be administered in either first intervention period or second intervention period.

Treatment:

Drug: Placebo