Experimental Study to Validate the Modified Glucose Disposal Test

NCT ID: NCT01152372

Last Updated: 2011-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-11-30

Brief Summary

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

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Arm 1

Beta cell function by frequently sampled intravenous glucose tolerance test

Group Type OTHER

Insulin, glucose and staple isotopes

Intervention Type PROCEDURE

Arm 2

Modified glucose disposal test assessment of insulin sensitivity, endogenous glucose production and insulin secretion

Group Type OTHER

Insulin, glucose and staple isotopes

Intervention Type PROCEDURE

Arm 3

Endogenous glucose production and insulin sensitivity by isotope dilution and isoglycemic, heperinsulinemic clamp

Group Type OTHER

Insulin, glucose and staple isotopes

Intervention Type PROCEDURE

Interventions

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Insulin, glucose and staple isotopes

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Profil Institute For Clinical Research, Inc. (Picr)

Chula Vista, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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MB122-003

Identifier Type: -

Identifier Source: org_study_id

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