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Sponsors and Collaborators: |
KineMed Daiichi Sankyo Inc. University Medical Centre Groningen Diabetes & Glandular Disease Research Associates |
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Information provided by: | KineMed |
ClinicalTrials.gov Identifier: | NCT00476710 |
This project will compare the amount of bile acids and their kinetics in overweight and obese people with normal glucose metabolism, impaired glucose tolerance and frank type 2 diabetes. We hypothesize that bile acids will behave differently in these groups. We will also explore the effects of Colesevelam HCl, a medicine that lowers LDL cholesterol by binding bile acids, on bile acids in those groups. We hypothesize the drug may have different actions on bile acids in subjects with different degrees of abnormal glucose metabolism.
Condition | Intervention |
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Type 2 Diabetes Mellitus Impaired Glucose Tolerance |
Drug: Colesevelam HCl |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Effects of Colesevelam HCl On Bile Acid Pools And Kinetic Parameters in Normal Subjects, Subjects With Impaired Glucose Tolerance, And Subjects With Type 2 Diabetes Mellitus |
Estimated Enrollment: | 36 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2007 |
Bile acids, which are synthesized from cholesterol in the liver, play a key role in digestion as they solubilize dietary lipids and aid their absorption in the digestive tract. While for many years bile acids have been characterized by this digestive role, recent research indicates that bile acids play other important roles. Because bile acids have been shown to act in signaling pathways that affect metabolism, there has been renewed interest in investigations of their effects. This study explores potential differences in bile acid kinetics based on insulin resistance or type 2 diabetes at baseline.
Colesevelam HCl is a bile acid sequestrant, which in addition to its primary role in lowering serum LDL-C levels, has secondarily been implicated in lowering blood glucose levels. This study explores the relationship between insulin resistance and type 2 diabetes and changes in bile acid pool sizes and kinetics with colesevelam treatment. Isotopically labeled bile acids will be administered to subjects before and after treatment with colesevelam and comparisons will be made in bile acid pool size, fractional turnover rate, and synthesis rate in the three study groups.
Ages Eligible for Study: | 40 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Diabetic Subjects
Normal Subjects
Impaired Glucose Tolerance Subjects
Exclusion Criteria:
United States, Texas | |
Diabetes & Glandular Disease Research Associates, Inc. | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Bruce Slade 210-615-5565 bslade@dgdresearch.com | |
Principal Investigator: Sherwyn L Schwartz, MD |
Principal Investigator: | Elizabeth J Murphy, MD | KineMed, Inc. |
Principal Investigator: | Folkert Kuipers, PhD | University Medical Centre Groningen |
Study ID Numbers: | KM-11B |
Study First Received: | May 18, 2007 |
Last Updated: | May 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00476710 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Type 2 diabetes mellitus Bile acid Stable isotope Colesevelam HCl Impaired Glucose Tolerance |
Colesevelam Hyperglycemia Metabolic Diseases Glucose Intolerance Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Antilipemic Agents Anticholesteremic Agents Pharmacologic Actions |