Completed

Incretin Hormones' Impact on Glucose Metabolism After Gastric Bypass

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Study Aim

This early phase study aims to understand the basic science behind the impact of incretin hormones on glucose metabolism after gastric bypass surgery, by evaluating the change in total disposition index, a measure of insulin secretion and insulin sensitivity, before and after the procedure.

What is being tested

Exendin 9,39

+ Placebo

Drug
Who is being recruted

Diabetes Mellitus+3

+ Endocrine System Diseases

+ Metabolic Diseases

From 20 to 65 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledEarly Phase 1
Interventional
Study Start: June 2011
See protocol details

Summary

Principal SponsorAdrian Vella
Last updated: December 4, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2011

Actual date on which the first participant was enrolled.

The study is being undertaken to understand how a gastric bypass can affect a subject's diabetes even prior to their losing significant amounts of weight. The hypothesis of this study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration in insulin secretion after Roux-en-Y Gastric Bypass (RYGB) surgery.

NCT01843855
Principal SponsorAdrian Vella
Last updated: December 4, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes Mellitus, Type 2

Criteria

2 inclusion criteria required to participate
Subjects registered to receive a Roux-en-Y Gastric Bypass (RYGB)
Subjects with type 2 diabetes mellitus or impaired fasting glucose concentration of > 110 mg/dL
4 exclusion criteria prevent from participating
For female subject: positive pregnancy test at the time of enrollment in study
Subjects taking thiazolidinediones
Subjects with active microvascular or macrovascular complications of their diabetes
Subjects with active systemic illness

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Subjects randomized to this arm will receive an infusion of exendin 9,39 of 300mmol/kg/min for 360 minutes.

Group II

Placebo
Subjects randomized to this arm will receive a saline infusion for 360 minutes.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Mayo Clinic

Rochester, United StatesOpen Mayo Clinic in Google Maps
CompletedOne Study Center