End-stage Renal DiseaseNCT00234156
The Effect of Fructose on Blood Fats in Dialysis Patients and Healthy Volunteers
A study testing oral fructose and high fat diet in people with End-stage Renal Disease, run by Rockefeller University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- oral fructose and high fat diet
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- Willing and able to sign an informed consent.
- Willing to refrain from participation in an investigational drug study for the duration of the study.
- 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
- Systemic illnesses, including diabetes (FBS >126 twice or abnormal OGTT), cardiovascular disease, hepatitis, endocrine disease, HIV infection.
- Prescription medications, including contraceptives.
- Acute febrile illness within 1 month of admission.
- BMI >35 (markedly obese) or>10% below maximum weight.
- Weight change of >10% usual weight in the previous 6 months.
- Blood pressure >140/90.
- HB <11 female, <12 male.
- CRP >5.0 on 2 occasions. 7/15/2008 Form version 6/13/2005 #LHU-0471-0407 Page 9of 16f
- Abuse of ethanol (greater than 2 drinks/day) or illicit drugs.
- Cigarette smoking >1/2 pack/day.
- Unusual diet or extreme physical activity (e.g. marathon runner).
- 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.
Who cannot join
- 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
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- 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
- Healthy Controls:
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockefeller University Hospital
New York, New York, 10021
About this study
Official title: Sensitivity to Fructose-Induced Palmitate Synthesis in End-Stage Renal Disease
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.
Read the 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.
- Conditions
- End-stage Renal Disease
- Being tested
- oral fructose and high fat diet
- Keywords
- Fructose, Lipogenesis, Triglycerides, Dialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral fructose and high fat dietProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: oral fructose and high fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak percent de novo palmitate in blood triglycerides after oral fructose
Measured: day 1 and day 6
Secondary outcomes (2)
Relationship between TNF and/or its soluble receptors and % newly formed palmitate
Measured: Day 1 and Day 6
fatty acid composition of TG and adipose tissue
Measured: Day 1 of hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startSep 2004
- Primary completionOct 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert C. Atkins Foundation, The Rogosin Institute
- Responsible party
- Sponsor
- Investigators
- Lisa C. Hudgins, MD, Principal investigator, Rockefeller University, Rogosin Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234156
- Sponsor's protocol ID
- RUH IRB #LHU 0471
- Status last verified
- Jan 2012
- First submitted
- 5 Oct 2005
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21252253
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity to Fructose-Induced Palmitate Synthesis in End-Stage Renal Disease
- ClinicalTrials.gov ID
- NCT00234156
- Acronym / sponsor ID
- RUH IRB #LHU 0471
- Conditions
- End-stage Renal Disease
- Keywords
- Fructose, Lipogenesis, Triglycerides, Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- Robert C. Atkins Foundation, The Rogosin Institute
- Study start
- Sep 2004
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 6 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| renal disease | Active comparator | Procedure: oral fructose and high fat dietHigh 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 | Active comparator | Procedure: oral fructose and high fat dietHigh 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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).
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral fructose and high fat dietHigh 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 or surgery | normal, renal disease |
Primary outcome
Peak percent de novo palmitate in blood triglycerides after oral fructose
Time frame: day 1 and day 6
2 secondary outcomes
Relationship between TNF and/or its soluble receptors and % newly formed palmitate
Time frame: Day 1 and Day 6
fatty acid composition of TG and adipose tissue
Time frame: Day 1 of hospital admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
- Derived from this study: PubMed 21252253Hudgins 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa C. Hudgins, MD principal investigator
Rockefeller University, Rogosin Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral fructose and high fat diet in people with End-stage Renal Disease, run by Rockefeller University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak percent de novo palmitate in blood triglycerides after oral fructose (time frame: day 1 and day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00234156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2012.