NCT01843881

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.2 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
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 4, 2013

Status Verified

December 1, 2013

Enrollment Period

1.5 years

First QC Date

April 26, 2013

Last Update Submit

December 3, 2013

Conditions

Type 2 Diabetes Mellitus

Keywords

Gastric Bypassbariatric surgerycarbohydrate metabolism

Outcome Measures

Primary Outcomes (1)

  • Change in Total Disposition Index from Study 1 (Exendin 9,39) to Study 2 (saline)

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

    Day 1, Day 2 (approximately 2 weeks after day 1)

Study Arms (2)

Exendin 9, 39

EXPERIMENTAL

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

Drug: Exendin 9, 39

Placebo

PLACEBO COMPARATOR

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

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 - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

exendin (9-39)

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
CROSSOVER
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

March 1, 2012

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

December 4, 2013

Record last verified: 2013-12

Locations

US(1)