Effects of Colesevelam HCl On Bile Acid Kinetics
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|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|
- Bile Acid Pool Size and Kinetic Parameters [ Time Frame: 60 days of treatment ]
- Resting Metabolic Rate [ Time Frame: 60 days of treatment ]
|Study Start Date:||May 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476710
|United States, Texas|
|Diabetes & Glandular Disease Research Associates, Inc.|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Elizabeth J Murphy, MD||KineMed, Inc.|
|Principal Investigator:||Folkert Kuipers, PhD||University Medical Centre Groningen|