Experimental Study to Validate the Modified Glucose Disposal Test
Phase 1
Completed
- Conditions
- Diabetes
- Interventions
- Procedure: Insulin, glucose and staple isotopes
- Registration Number
- NCT01152372
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Evaluate the modified GDT as a measure of key metabolic characteristics in healthy subjects and those with type 2 diabetes mellitus
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Clinical diagnosis of Type 2 diabetes
- Clinically healthy
- Drug naive or on a stable dose of metformin monotherapy and/or a secretagogue
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Exclusion Criteria
- Type 1 Diabetes
- History of significant heart disease.
- Bariatric surgery
- Exposure to fibrates, thiazolidinediones, insulin, exenatide, pramlintide or DPP-IV inhibitors
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Insulin, glucose and staple isotopes Beta cell function by frequently sampled intravenous glucose tolerance test Arm 2 Insulin, glucose and staple isotopes Modified glucose disposal test assessment of insulin sensitivity, endogenous glucose production and insulin secretion Arm 3 Insulin, glucose and staple isotopes Endogenous glucose production and insulin sensitivity by isotope dilution and isoglycemic, heperinsulinemic clamp
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Characterize the patterns of intermediate metabolites in healthy subjects and subjects with type 2 diabetes mellitus within 24 hours
Trial Locations
- Locations (1)
Profil Institute For Clinical Research, Inc. (Picr)
🇺🇸Chula Vista, California, United States