Experimental Study to Validate the Modified Glucose Disposal Test
Experimental Medicine Study to Validate the Modified Glucose Disposal Test in Healthy Subjects and Subjects With Type 2 Diabetes
1 other identifier
interventional
36
1 country
1
Brief Summary
Evaluate the modified GDT as a measure of key metabolic characteristics in healthy subjects and those with type 2 diabetes mellitus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 diabetes
Started Jun 2010
1 active site
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
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 16, 2010
CompletedFirst Posted
Study publicly available on registry
June 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFebruary 23, 2011
August 1, 2010
5 months
June 16, 2010
February 22, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Glucose (labeled and unlabeled), insulin and c-peptide will be measured to calculate insulin sensitivity, endogenous glucose production and insulin secretion
within 24 hours
Secondary Outcomes (1)
Characterize the patterns of intermediate metabolites in healthy subjects and subjects with type 2 diabetes mellitus
within 24 hours
Study Arms (3)
Arm 1
OTHERBeta cell function by frequently sampled intravenous glucose tolerance test
Arm 2
OTHERModified glucose disposal test assessment of insulin sensitivity, endogenous glucose production and insulin secretion
Arm 3
OTHEREndogenous glucose production and insulin sensitivity by isotope dilution and isoglycemic, heperinsulinemic clamp
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Type 2 diabetes
- Clinically healthy
- Drug naive or on a stable dose of metformin monotherapy and/or a secretagogue
You may not qualify if:
- Type 1 Diabetes
- History of significant heart disease.
- Bariatric surgery
- Exposure to fibrates, thiazolidinediones, insulin, exenatide, pramlintide or DPP-IV inhibitors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Profil Institute For Clinical Research, Inc. (Picr)
Chula Vista, California, 91911, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 16, 2010
First Posted
June 29, 2010
Study Start
June 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
February 23, 2011
Record last verified: 2010-08