Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-05 @ 1:56 AM
Study NCT ID:
NCT00234156
Status:
COMPLETED
Last Update Posted:
2012-01-11
First Post:
2005-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Fructose on Blood Fats in Dialysis Patients and Healthy Volunteers
Sponsor:
Rockefeller University
Organization:
Study Overview
Official Title:
Sensitivity to Fructose-Induced Palmitate Synthesis in End-Stage Renal Disease
Status:
COMPLETED
Status Verified Date:
2012-01
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 study will evaluate how a common dietary sugar (fructose) raises blood fats (triglycerides). We will determine whether the production of fat from fructose is higher in dialysis patients compared to healthy volunteers. Dialysis patients have high levels of hormone-like substances called cytokines that may increase blood fats. The results will help set better guidelines for diets for the general population and patients with kidney disease who are at high risk for heart attack and stroke.
There will be one or two outpatient screening visit(s) and a one-week (6 nights) stay at the Rockefeller University Hospital.
There will be one or two outpatient screening visit(s) and a one-week (6 nights) stay at the Rockefeller University Hospital.
Detailed Description:
Fifteen hemodialysis patients and 15 healthy volunteers will be studied.
Outpatient screening visit(s): consent, fasting blood and urine analysis, a physical exam, an EKG and a 2-hour oral glucose tolerance test to screen for diabetes.
Inpatient admission:
* Standardized diet that follows the guidelines for hemodialysis patients and healthy volunteers to maintain a stable weight.
* Blood and urine sampling. The total amount of blood drawn is less than 1 cup.
* To measure the production of fat from fructose, a trace amount of a non-radioactive labeled precursor of fat (13C-acetate) will be infused through a venous catheter for 22 hours.
At the end of the infusion, a sweet drink (fructose in 1 ounce of water) will be given orally every half hour for 6 hours.
• Two small samples of fat taken right below the skin will be obtained after injection of a small amount of numbing medicine into the abdominal and gluteal regions.
Dialysis patients will receive their usual dialysis at The Rogosin Institute Manhattan, Brooklyn or Queens Dialysis Units.
Outpatient screening visit(s): consent, fasting blood and urine analysis, a physical exam, an EKG and a 2-hour oral glucose tolerance test to screen for diabetes.
Inpatient admission:
* Standardized diet that follows the guidelines for hemodialysis patients and healthy volunteers to maintain a stable weight.
* Blood and urine sampling. The total amount of blood drawn is less than 1 cup.
* To measure the production of fat from fructose, a trace amount of a non-radioactive labeled precursor of fat (13C-acetate) will be infused through a venous catheter for 22 hours.
At the end of the infusion, a sweet drink (fructose in 1 ounce of water) will be given orally every half hour for 6 hours.
• Two small samples of fat taken right below the skin will be obtained after injection of a small amount of numbing medicine into the abdominal and gluteal regions.
Dialysis patients will receive their usual dialysis at The Rogosin Institute Manhattan, Brooklyn or Queens Dialysis Units.
Study Oversight
Has Oversight DMC:
False
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?: