Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476710
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2007-05-18
Brief Title:
Effects of Colesevelam HCl On Bile Acid Kinetics
Sponsor:
KineMed
Organization:
KineMed
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None