Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234156
Status:
COMPLETED
Last Update Posted:
2012-01-11
First Post:
2005-10-05
Brief Title:
The Effect of Fructose on Blood Fats in Dialysis Patients and Healthy Volunteers
Sponsor:
Rockefeller University
Organization:
Rockefeller University
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 visits and a one-week 6 nights stay at the Rockefeller University Hospital
There will be one or two outpatient screening visits 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 visits 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 visits 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:
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