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Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)

NCT00990184 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2012-11-21

Study results available
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Summary

The objective of this study is to determine the effect of 8 weeks of treatment with colesevelam HCl 3.75 g once daily with the evening meal on ß-cell function by evaluating the acute insulin response (AIRg) to an intravenous glucose load in subjects with prediabetes (impaired fasting glucose).

Conditions

Interventions

DRUG

Colesevelam

colesevelam HCl 3.75 g once daily orally with the evening meal

OTHER

placebo

tablet (s) orally given with evening meal

Sponsors & Collaborators

  • VA Puget Sound Health Care System

    collaborator FED

  • Seattle Institute for Biomedical and Clinical Research

    lead OTHER

Principal Investigators

  • Steven E Kahn, MB CHB · VA Puget Sound Health Care System

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-10-31
Completion
2010-10-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00990184 on ClinicalTrials.gov