Prediabetes Clinical Trial
Official title:
A Single-Blind Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)
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).
Colesevelam is a bile acid sequestrant that was initially approved for treatment of patients
with dyslipidemia. Subsequently it was observed that patients with type 2 diabetes receiving
this medication had improved glucose control. However, the mechanism(s) by which it lowers
glucose concentrations has not been determined.
Glucose metabolism is enhanced following oral nutrient ingestion by the action of the
incretin hormones. The two major incretin hormones are the peptides glucagon-like peptide-1
(GLP-1) and glucose-dependent insulinotropic peptide (GIP), which are released from the
intestinal tract wall in response to a meal. Of these two peptides, GLP-1 appears to be more
important in regulating glucose metabolism. In the presence of elevated plasma glucose,
GLP-1 promotes insulin release from the ß-cells of the pancreas. GLP-1 also suppresses
glucagon release, and thereby inhibits hepatic glucose output. Administration of GLP-1 by
infusion or by subcutaneous injection has been shown to improve glucose tolerance in type 2
diabetic patients.
The purpose of this study is therefore to determine in a cohort of individuals with
prediabetes, who have an elevated fasting plasma glucose and are at increased risk of
developing type 2 diabetes, whether the glucose lowering properties of colesevelam occur by
it improving insulin sensitivity, islet ß-cell function or both. Further, by assessing the
effect of colesevelam on incretin hormone release, it will be possible to determine whether
any improvement in islet ß-cell function is due to enhanced incretin stimulation.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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