Experimental Study to Validate the Modified Glucose Disposal Test

Bristol-Myers Squibb36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Diabetes

Interventions

Insulin, glucose and staple isotopesPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Profil Institute For Clinical Research, Inc. (Picr)

Chula Vista, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Characterize the patterns of intermediate metabolites in healthy subjects and subjects with type 2 diabetes mellitus

Time frame: within 24 hours

Data from ClinicalTrials.gov

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