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).
Status | Completed |
Enrollment | 21 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Males or females (postmenopausal, surgically sterile or using double-barrier method of contraception), aged 18-75 years, FPG 100-115 mg/dl at screening (average of 2 measurements during screening; no individual measurement outside of the range 92-125 mg/dl) - In good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis - HbA1c <6.5% at screening - Body mass index (BMI) in the range of 22-40 kg/m2 inclusive and with a stable (+/-2.5 kg) weight for the last 6 months - Subjects must be willing to: - Maintain prior exercise and dietary habits throughout the study - Comply with all study requirements - Provide written informed consent Exclusion Criteria: - Pregnant or lactating females - Patients diagnosed with type 2 diabetes or that have taken glucose-lowering agents or insulin, except during pregnancy - Chronic oral or parenteral corticosteroid treatment (>7 consecutive days of treatment) within 8 weeks prior to screening - HIV protease inhibitors - Warfarin or phenytoin use - Triglycerides >500 mg/dl - History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection - History of dysphagia, swallowing disorders or intestinal motility disorder - History of pancreatitis - Uncontrolled hypothyroidism - Individuals with clinical hepatic disease or liver function tests greater than =2 times upper limits of normal within 30 days preceding the first dose of study drug - On a weight loss program with ongoing weight loss, or starting an intensive exercise program within 4 weeks of study initiation - Current or prior (within the past 3 months) treatment with a bile acid sequestrant (colesevelam, colestipol, colestimide, or cholestyramine) - Use of any investigational drug in the last 30 days - Donation of one unit (500 ml) or more of blood, significant blood loss equaling at least one unit of blood within the past 2 weeks or a blood transfusion within 8 weeks prior to screening - Employment by the research center |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Seattle Institute for Biomedical and Clinical Research | VA Puget Sound Health Care System |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute Insulin Response (AIRg) to Intravenous Glucose | Increase in insulin following glucose injection. AIRg is measured as the magnitude of the insulin response to an intravenous glucose injection calculated over the 10 minutes following glucose administration. | Baseline and 8 weeks | No |
Secondary | Insulin Sensitivity | Tissue response to circulating insulin in the blood. Insulin sensitivity is measured using a mathematical model that quantifies the fractional rate of change in glucose concentrations per unit of insulin. Low values are insulin resistant and high values are insulin sensitive. *Please note: the "-1" in the Unit of Measure should be a superscripted value. | Baseline and 8 weeks | No |
Secondary | Glucose Disappearance Rate | Rate of fall of glucose in the blood | Baseline and 8 weeks | No |
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