NCT01843855

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for early_phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 4, 2013

Status Verified

December 1, 2013

Enrollment Period

2.1 years

First QC Date

April 26, 2013

Last Update Submit

December 3, 2013

Conditions

Type 2 Diabetes Mellitus

Keywords

Gastric Bypassbariatric surgeryglucose metabolism

Outcome Measures

Primary Outcomes (1)

  • Change in Total Disposition Index from Study 1 (pre-RYGB) to Study 2 (post-RYGB)

    The total disposition index equals the product of insulin secretion and insulin sensitivity.

    baseline, 4 weeks post-operative intervention

Study Arms (2)

Exendin 9,39

EXPERIMENTAL

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

Drug: Exendin 9,39

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Exendin 9,39DRUG

Exendin 9,39 is a competitive antagonist of endogenous GLP-1.

Exendin 9,39
PlaceboDRUG

A saline infusion will be given to match the study drug infusion.

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with type 2 diabetes mellitus or impaired fasting glucose concentration of \> 110 mg/dL
  • Subjects registered to receive a Roux-en-Y Gastric Bypass (RYGB).

You may not qualify if:

  • Subjects taking thiazolidinediones
  • Subjects with active systemic illness
  • Subjects with active microvascular or macrovascular complications of their diabetes
  • For female subject: positive pregnancy test at the time of enrollment in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905-0001, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Adrian Vella, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant, Endocrinology

Study Record Dates

First Submitted

April 26, 2013

First Posted

May 1, 2013

Study Start

June 1, 2011

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

December 4, 2013

Record last verified: 2013-12

Locations

US(1)