Experimental Study to Validate the Modified Glucose Disposal Test

February 22, 2011 updated by: Bristol-Myers Squibb

Experimental Medicine Study to Validate the Modified Glucose Disposal Test in Healthy Subjects and Subjects With Type 2 Diabetes

Evaluate the modified GDT as a measure of key metabolic characteristics in healthy subjects and those with type 2 diabetes mellitus

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Profil Institute For Clinical Research, Inc. (Picr)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Type 2 diabetes
  • Clinically healthy
  • Drug naive or on a stable dose of metformin monotherapy and/or a secretagogue

Exclusion Criteria:

  • Type 1 Diabetes
  • History of significant heart disease.
  • Bariatric surgery
  • Exposure to fibrates, thiazolidinediones, insulin, exenatide, pramlintide or DPP-IV inhibitors

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Beta cell function by frequently sampled intravenous glucose tolerance test
Procedure: Insulin, glucose and staple isotopes
Other: Arm 2
Modified glucose disposal test assessment of insulin sensitivity, endogenous glucose production and insulin secretion
Procedure: Insulin, glucose and staple isotopes
Other: Arm 3
Endogenous glucose production and insulin sensitivity by isotope dilution and isoglycemic, heperinsulinemic clamp
Procedure: Insulin, glucose and staple isotopes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucose (labeled and unlabeled), insulin and c-peptide will be measured to calculate insulin sensitivity, endogenous glucose production and insulin secretion
Time Frame: within 24 hours
within 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Characterize the patterns of intermediate metabolites in healthy subjects and subjects with type 2 diabetes mellitus
Time Frame: within 24 hours
within 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

June 16, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 29, 2010

Study Record Updates

Last Update Posted (Estimate)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 22, 2011

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB122-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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