Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328211
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2006-05-18
Brief Title:
Intralumenal Effects on Cholesterol AbsorptionSynthesis
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Intralumenal Effects on Cholesterol AbsorptionSynthesis
Status:
COMPLETED
Status Verified Date:
2020-09
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:
The overall goal of this study is to better understand how cholesterol is absorbed and utilized in the bodymetabolism and how serum cholesterol affects the development of hardening of the arteries atherosclerosis The purpose of aim 1 is to assess the role of the amount of different bile acids in the intestine and how they affect the absorption synthesis and digestion of cholesterol The effect that these bile acids have on how fast the gall bladder empties and the release of a hormone in the blood after a meal will also be studied The purpose of aim 2 is to assess the role of phospholipid a fat containing the element phosphorus in the intestine and how it affects the absorption synthesis and digestion of cholesterol in normal people and in people with a genetic condition mdr3 deficiencythat affects phospholipid and bile acid metabolism The purpose of aim 3 is to assess the role of a material that acts like a detergent called Pluronic F-68 which is known to block the absorption of cholesterol The purpose of aim 4 is to determine if the cholesterol from food and the cholesterol made by the body are digested and absorbed differently
Detailed Description:
Cholesterol absorption plays a key role in cholesterol homeostasis and understanding the lumenal events that play key roles in absorption remain poorly understood The aims of the present study are fourfold 1 To determine whether previously observed effects on cholesterol absorption during bile acid feeding are related to changes in pool size and intestinal transit or meal stimulated gall bladder emptying or plasma cholecystokinin levels 2 To determine the effect of dietary sphingomyelin on cholesterol absorption micellar solubilization and synthesis in normal adults and to assess the effects of intralumenal cholesterol solubilization absorption and synthesis in adults with heterozygous mdr 3 deficiency a defect leading to low biliary phospholipid content 3 To determine the mechanism of action of a non-ionic detergent Pluronic F-68 by evaluating its effect on cholesterol solubilization and distribution between micelles and vesicles on cholesterol absorption and synthesis 4 To evaluate the intralumenal solubilization and distribution within micelles and vesicles of biliary compared to dietary cholesterol in humans and assess the impact of ezetimibe treatment on absorption of endogenous or exogenous cholesterol by assessing absorption of human contents in the biliary diverted rat lymph fistula model For each of these aims subjects will be studied while consuming well-controlled diets as outpatients with a combination of human and animal techniques Techniques employed for human studies will include state-of-the art techniques utilizing stable isotopes and isotope ratio mass spectrometry gas chromatography Translational studies in animals will be used including novel techniques to measure fat absorption as well as the use of the lymph fistula rat model for assessment of lipid absorption and hamsters for assessment of bile acid and sterol synthesis Integration of animalhuman techniques will provide tools to characterize the role of modifications of the intralumenal environment on cholesterol solubilization and human cholesterol absorption and synthesis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK068463 | NIH | None | httpsreporternihgovquickSearchR01DK068463 |