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(LHU-0471) Sensitivity to Fructose-Induced Palmitate Synthesis in End-Stage Renal Disease


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Sensitivity to Fructose-Induced Palmitate Synthesis in End-Stage Renal Disease (LHU-0471)

Principal Investigator:
Lisa Cooper Hudgins M.D.

Investigators:

Contact Information:
Lisa Hudgins, MD
Rockefeller University
1230 York Avenue
New York, NY 10021
Alt. Telephone: 1800-RU CARES
FAX: 212-327-7131
Contact Information:
Aline Baday
Telephone: 718-457-3000 x138
Alt. Telephone:
E-Mail: badaya@rockefeller.edu


Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
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.

If you join this study, you will have one or two outpatient screening visit(s) and a one-week (7 nights) stay at the Rockefeller University Hospital.



Detailed Description of Protocol:
We want to study 15 hemodialysis patients and 15 healthy volunteers.

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.

• Blood and urine sampling.

• To measure the production of fat from fructose, a trace amount of a non-radioactive labeled precursor of fat (13C-acetate) will be infused for 22 hours. During 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 (the size of a sesame seed, taken right below the skin) will be obtained after a small amount of numbing medicine. This procedure will take only a couple minutes.

If you are a dialysis patient, you will receive your usual dialysis at The Rogosin Institute Manhattan, Brooklyn or Queens Dialysis Units.

Profile:
Men and women ages 18-75 who are healthy volunteers or, who receive hemodialysis three times a week for at least six months



What specifically makes a person eligible for the study?
You may be eligible to enter this study:

• no diabetes, any unstable clinical condition, chronic infection (including hepatitis, HIV), or serious digestive problems

• no major obesity (BMI up to 35)

• cigarette smoking no more than half a pack per day

• for healthy volunteers: total cholesterol less than 240 mg/dL and triglycerides less than 150 mg/dL, no prescription medicines, stable weight

• for dialysis patients: total cholesterol less than 300 mg/dL and triglycerides less than 600 mg/dL, no cholesterol-lowering medicine, able to change from Renagel (has lipid effects) to Phoslo or Fosrenol for the duration of the study, able to stop Sensipar for 2 weeks



Gender:
Both

Age(s):
18-75 years

Children permitted to participate:
No

Potential Benefits.....
There will be no direct benefit to you. However, if you have kidney disease, you may benefit in the future from what we learn from this study. Others may also benefit from new information which links diet and heart disease.



Compensation:
There is no cost to you for being in this research study.

To help pay for your costs and time spent being in this study, you will receive a $425 stipend.