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

NCT00234156 | Completed

• 1 other identifier: RUH IRB #LHU 0471
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease

Keywords

Fructose; Lipogenesis; Triglycerides; Dialysis

Outcome Measures

Primary Outcomes (1)

• Peak percent de novo palmitate in blood triglycerides after oral fructose

  day 1 and day 6

Secondary Outcomes (2)

• Relationship between TNF and/or its soluble receptors and % newly formed palmitate

  Day 1 and Day 6

• fatty acid composition of TG and adipose tissue

  Day 1 of hospital admission

Study Arms (2)

renal disease

ACTIVE COMPARATOR

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

normal

ACTIVE COMPARATOR

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

Interventions

oral fructose and high fat diet PROCEDURE

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.

normal; renal disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females, 18-75 years of age.
• 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.
• Fasting TG \<600 mg/dl, LDL cholesterol \<190 mg/dl (off lipid-lowering medication)
• 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.
• 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).
• 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.
• Willing and able to sign an informed consent.
• Willing to refrain from participation in an investigational drug study for the duration of the study.

You may not qualify if:

• Diabetes (fasting blood sugar \>126 twice or an abnormal 2 hour OGTT)
• Unstable clinical condition, including acute febrile illness within 1 month of admission
• Chronic infection, including hepatitis and HIV infection
• Gastrointestinal disease resulting in significant GI dysfunction or malabsorption
• Lipid-lowering medication
• 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
• BMI \>35 (markedly obese)
• Hemoglobin \<10.0
• Prednisone, estrogen/progesterone, other steroids, Synthroid, endocrine disease
• Coumadin and an INR \>1.5
• Cigarette smoking \>1/2 pack/day
• Abuse of ethanol (greater than 2 drinks/day) or illicit drugs
• If female, pregnant or breast feeding
• Participation in a study of an investigational drug during the 30 days preceding the start of the screening period
• Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study

Sponsors & Collaborators

• Rockefeller University: lead
• Robert C. Atkins Foundation: collaborator
• The Rogosin Institute: collaborator

Study Sites (1)

Rockefeller University Hospital

New York, New York, 10021, United States

Location

Related Publications (1)

• Hudgins LC, Parker TS, Levine DM, Hellerstein MK. A dual sugar challenge test for lipogenic sensitivity to dietary fructose. J Clin Endocrinol Metab. 2011 Mar;96(3):861-8. doi: 10.1210/jc.2010-2007. Epub 2011 Jan 20.

  PMID: 21252253 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Fructose; Diet, High-Fat

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Lisa C. Hudgins, MD

  Rockefeller University, Rogosin Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2005
• First Posted: October 6, 2005
• Study Start: September 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2009
• Last Updated: January 11, 2012

Record last verified: 2012-01

Locations

US (1)