Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014781
Status:
COMPLETED
Last Update Posted:
2009-03-12
First Post:
2001-04-10
Brief Title:
Study of Hepatic Glucose Production and De Novo Lipogenesis in Patients With Cystic Fibrosis
Sponsor:
University of Utah
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-03
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:
OBJECTIVES
I Determine the amount of hepatic glucose production derived from gluconeogenesis and glycogenolysis in the post-absorptive state in patients with cystic fibrosis
II Determine de novo lipogenesis in relationship to resting energy expenditure in this patient population
I Determine the amount of hepatic glucose production derived from gluconeogenesis and glycogenolysis in the post-absorptive state in patients with cystic fibrosis
II Determine de novo lipogenesis in relationship to resting energy expenditure in this patient population
Detailed Description:
PROTOCOL OUTLINE
Patients undergo an oral glucose tolerance test OGTT in which blood is drawn from an IV in the arm 6 times over 3 hours After the first blood draw patients receive a beverage containing sugar and write down everything they ate and drank during the 24 hours before study entry Patients also undergo a dual energy x-ray absorptiometry DEXA scan over 15 minutes
Within 2 weeks after the OGTT patients keep a journal of everything they ate and drank over 3 days Patients are fed a selected meal the following evening and receive saline fluids IV overnight During the night patients receive 2 doses of oral doubly labeled water The next morning patients receive 12-13Cacetate IV A liquid mixed meal Ensure Plus is ingested hourly throughout the day Patients also undergo hood indirect calorimetry over 30 minutes twice to measure resting energy expenditure All urine is collected
Patients undergo an oral glucose tolerance test OGTT in which blood is drawn from an IV in the arm 6 times over 3 hours After the first blood draw patients receive a beverage containing sugar and write down everything they ate and drank during the 24 hours before study entry Patients also undergo a dual energy x-ray absorptiometry DEXA scan over 15 minutes
Within 2 weeks after the OGTT patients keep a journal of everything they ate and drank over 3 days Patients are fed a selected meal the following evening and receive saline fluids IV overnight During the night patients receive 2 doses of oral doubly labeled water The next morning patients receive 12-13Cacetate IV A liquid mixed meal Ensure Plus is ingested hourly throughout the day Patients also undergo hood indirect calorimetry over 30 minutes twice to measure resting energy expenditure All urine is collected
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UUSOM-IRB-7835-00 | None | None | None |
| UUSOM-R03DK5660401 | None | None | None |