The Effect of Fructose on Blood Fats in Dialysis Patients and Healthy Volunteers

This study has been completed.
Sponsor:
Collaborators:
Robert C. Atkins Foundation
The Rogosin Institute
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00234156
First received: October 5, 2005
Last updated: January 10, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
End-stage Renal Disease
Procedure: oral fructose and high fat diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Sensitivity to Fructose-Induced Palmitate Synthesis in End-Stage Renal Disease

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Peak percent de novo palmitate in blood triglycerides after oral fructose [ Time Frame: day 1 and day 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship between TNF and/or its soluble receptors and % newly formed palmitate [ Time Frame: Day 1 and Day 6 ] [ Designated as safety issue: No ]
  • fatty acid composition of TG and adipose tissue [ Time Frame: Day 1 of hospital admission ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2004
Study Completion Date: October 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: renal disease

High fat diet: The composition will be: 35% of energy as fat, 50% carbohydrate, 15% protein (~1.3 g/kg), sat:mono:poly 1:3:1, cholesterol 200 mg/d, 30% starch,15% sugar, 3% fructose, and 25 gm fiber/d. This relatively high fat diet, which falls within the recommendations by the National Kidney Foundation for hemodialysis patients, will suppress fatty acid synthesis in normal volunteers.

Fructose in 360 ml water will be orally administered as 1.4 g/kg (~100 g or 400 kcal for a 70 kg person), divided into 30 mL (1 ounce) doses given every 1/2h for 6 hours.

Procedure: oral fructose and high fat diet

High fat diet: The composition will be: 35% of energy as fat, 50% carbohydrate, 15% protein (~1.3 g/kg), sat:mono:poly 1:3:1, cholesterol 200 mg/d, 30% starch,15% sugar, 3% fructose, and 25 gm fiber/d. This relatively high fat diet, which falls within the recommendations by the National Kidney Foundation for hemodialysis patients, will suppress fatty acid synthesis in normal volunteers.

Fructose in 360 ml water will be orally administered as 1.4 g/kg (~100 g or 400 kcal for a 70 kg person), divided into 30 mL (1 ounce) doses given every 1/2h for 6 hours.

Active Comparator: normal

High fat diet: The composition will be: 35% of energy as fat, 50% carbohydrate, 15% protein (~1.3 g/kg), sat:mono:poly 1:3:1, cholesterol 200 mg/d, 30% starch,15% sugar, 3% fructose, and 25 gm fiber/d. This relatively high fat diet, which falls within the recommendations by the National Kidney Foundation for hemodialysis patients, will suppress fatty acid synthesis in normal volunteers.

Fructose in 360 ml water will be orally administered as 1.4 g/kg (~100 g or 400 kcal for a 70 kg person), divided into 30 mL (1 ounce) doses given every 1/2h for 6 hours.

Procedure: oral fructose and high fat diet

High fat diet: The composition will be: 35% of energy as fat, 50% carbohydrate, 15% protein (~1.3 g/kg), sat:mono:poly 1:3:1, cholesterol 200 mg/d, 30% starch,15% sugar, 3% fructose, and 25 gm fiber/d. This relatively high fat diet, which falls within the recommendations by the National Kidney Foundation for hemodialysis patients, will suppress fatty acid synthesis in normal volunteers.

Fructose in 360 ml water will be orally administered as 1.4 g/kg (~100 g or 400 kcal for a 70 kg person), divided into 30 mL (1 ounce) doses given every 1/2h for 6 hours.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and females, 18-75 years of age.
  2. Chronic renal failure with hemodialysis 3x/week for at least 6 months and adequate dialysis as judged by a nephrologist who is not a study investigator.
  3. Fasting TG <600 mg/dl, LDL cholesterol <190 mg/dl (off lipid-lowering medication)
  4. Willing and able to change Renagel, a noncalcemic phosphate binder (poly[allylamine hydrochloride]) which has LDL-lowering effects, to the same amount of another phosphate binder for 1 month prior to the screening visit until the completion of the study.
  5. Willing and able to temporarily stop Sensipar (cinacalcet) for 1 week before the study admission until completion of the study (a total of ~2 weeks).
  6. Willing and able to stop ASA (except low dose ASA in patients with vascular disease), NSAID, fish oil, psyllium, other nonprescribed vitamins/supplements for 1 week prior to study until completion of study.
  7. Willing and able to sign an informed consent.
  8. Willing to refrain from participation in an investigational drug study for the duration of the study.

Exclusion Criteria:

  1. Diabetes (fasting blood sugar >126 twice or an abnormal 2 hour OGTT)
  2. Unstable clinical condition, including acute febrile illness within 1 month of admission
  3. Chronic infection, including hepatitis and HIV infection
  4. Gastrointestinal disease resulting in significant GI dysfunction or malabsorption
  5. Lipid-lowering medication
  6. Mean systolic blood pressure >180 or diastolic pressure >110 taken immediately before 6 dialysis treatments over the 2 weeks before the screening visit 7/15/2008 Form version 6/13/2005 #LHU-0471-0407 Page 8of 16f
  7. BMI >35 (markedly obese)
  8. Hemoglobin <10.0
  9. Prednisone, estrogen/progesterone, other steroids, Synthroid, endocrine disease
  10. Coumadin and an INR >1.5
  11. Cigarette smoking >1/2 pack/day
  12. Abuse of ethanol (greater than 2 drinks/day) or illicit drugs
  13. If female, pregnant or breast feeding
  14. Participation in a study of an investigational drug during the 30 days preceding the start of the screening period
  15. Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study

Healthy Controls:

Inclusion Criteria

1. Male and females, 18-75 years of age 2. LDL <160 mg/dl, HDL-C >30 mg/dl, TG <250 mg/dl 3. Willing and able to stop ASA, NSAID, fish oil, psyllium, other vitamins/supplements for 1 week prior to study until completion of study 4. Willing and able to sign an informed consent 5. Willing to refrain from participation in an investigational drug study for the duration of the study Exclusion Criteria

  1. Systemic illnesses, including diabetes (FBS >126 twice or abnormal OGTT), cardiovascular disease, hepatitis, endocrine disease, HIV infection.
  2. Prescription medications, including contraceptives.
  3. Acute febrile illness within 1 month of admission.
  4. BMI >35 (markedly obese) or>10% below maximum weight.
  5. Weight change of >10% usual weight in the previous 6 months.
  6. Blood pressure >140/90.
  7. HB <11 female, <12 male.
  8. CRP >5.0 on 2 occasions. 7/15/2008 Form version 6/13/2005 #LHU-0471-0407 Page 9of 16f
  9. Abuse of ethanol (greater than 2 drinks/day) or illicit drugs.
  10. Cigarette smoking >1/2 pack/day.
  11. Unusual diet or extreme physical activity (e.g. marathon runner).
  12. If female, pregnant or breast feeding.
  13. Participation in a study of an investigational drug during the 30 days preceding the start of the screening period.
  14. Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00234156

Locations
United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
Robert C. Atkins Foundation
The Rogosin Institute
Investigators
Principal Investigator: Lisa C. Hudgins, MD Rockefeller University, Rogosin Institute
  More Information

No publications provided by Rockefeller University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00234156     History of Changes
Other Study ID Numbers: RUH IRB #LHU 0471
Study First Received: October 5, 2005
Last Updated: January 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Rockefeller University:
Fructose
Lipogenesis
Triglycerides
Dialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on August 20, 2014