Elevated TriglyceridesPhase 1NCT00535535
Fructose-Induced Palmitate Synthesis in Overweight Subjects
A Phase 1 study testing Fructose and Fructose and Glucose in people with Elevated Triglycerides and Diabetes, run by Rockefeller University at 1 site in United States.
Trial summary
Dietary fructose potently exacerbates the dyslipidemia associated with obesity, insulin resistance and accelerated atherosclerosis. In a randomized crossover outpatient study of 15 overweight adults, we will measure the increase over 4 hours in serum VLDL triglyceride palmitate made by the liver from each single oral… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Elevated Triglycerides, Diabetes, Cardiovascular Disease
- What is being tested?
- Fructose and Fructose and Glucose
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2011
- Phase
- Phase 1
- 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
- Males and females, 18-75 years of age
- Body mass index (BMI) 25-35 and within 10% of maximum weight
- Willing and able to stop fish oil, psyllium, other non-prescribed vitamins/supplements for 1 week prior to study until completion of study
- Willing to not drink alcohol for 24 h before each day of blood sampling
Who cannot join
- Diabetes or other endocrine disorder, hepatitis or other liver disorder, HIV, or autoimmune disease
- Medication(s) known to affect lipids, including hormonal contraceptives
- Recent acute illness
- Gastrointestinal disease resulting in significant GI dysfunction or malabsorption
- History of fasting TG >800 mg/dl
- History of ethanol abuse (current intake >2 drinks/d) or illicit drugs
Show all 11Show fewer
- History of severe psychiatric illness
- If female, pregnant or breastfeeding
- Participation in an investigational drug study within one month of screening
- Unusual diet or extreme level of physical activity
- Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Dietary fructose potently exacerbates the dyslipidemia associated with obesity, insulin resistance and accelerated atherosclerosis. In a randomized crossover outpatient study of 15 overweight adults, we will measure the increase over 4 hours in serum VLDL triglyceride palmitate made by the liver from each single oral dose of fructose (0.5 g/kg), fructose:glucose 1:1 (1 g/kg) or fructose:glucose 1:1 (2 g/kg). Our hypotheses are that the synthesis of palmitate from dietary fructose will be 1) greater when consumed with glucose and 2) show a dose-response. The lipogenic responses will be compared and correlated with markers of carbohydrate and lipid flux measured after fasting and post-fructose. The results will serve as a guide to the development of a new outpatient probe of the de novo lipogenic pathway in subjects who vary in their lipogenic response to oral fructose. These studies should ultimately yield valuable new information about the mechanisms linking dietary carbohydrate to elevated triglycerides, diabetes and cardiovascular disease.
- Conditions
- Elevated Triglycerides, Diabetes, Cardiovascular Disease
- Being tested
- Fructose, Fructose and Glucose
- Keywords
- Elevated triglycerides, Diabetes, Cardiovascular disease
- Medical subject headings
- Hypertriglyceridemia, Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FructoseDietary supplement
Fructose, 0.5 g/kg
Fructose and GlucoseDietary supplement
Fructose:Glucose 1:1, 1 g/kg
Fructose and GlucoseDietary supplement
Fructose:Glucose 1:1, 2g/kg
What is being measured
The primary outcome is the main question the study is designed to answer.
A comparison of the iAUC in VLDL TG palmitate 4 hours after F:G1:1, 1g/kg, vs. 1) fructose 0.5g/kg, and 2) F:G:1:1, 2g/kg.
Secondary outcomes (1)
Linear regression analysis of the relationship between the iAUC in VLDL TG palmitate after oral fructose and markers of carbohydrate and lipid flux
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2011
- Study completionDec 2011
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 Elevated TriglyceridesStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- The Rogosin Institute
- Responsible party
- Sponsor
- Investigators
- Lisa C Hudgins, MD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535535
- Sponsor's protocol ID
- LHU-0616
- Status last verified
- Sep 2013
- First submitted
- 24 Sep 2007
- Last updated
- 23 Sep 2013
- Results posted
- 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 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fructose-Induced Palmitate Synthesis in Overweight Subjects
- ClinicalTrials.gov ID
- NCT00535535
- Acronym / sponsor ID
- LHU-0616
- Conditions
- Elevated Triglycerides, Diabetes, Cardiovascular Disease
- Keywords
- Elevated triglycerides, Diabetes, Cardiovascular disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- The Rogosin Institute
- Study start
- Aug 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Sep 2007 (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.
Dietary fructose potently exacerbates the dyslipidemia associated with obesity, insulin resistance and accelerated atherosclerosis. In a randomized crossover outpatient study of 15 overweight adults, we will measure the increase over 4 hours in serum VLDL triglyceride palmitate made by the liver from each single oral dose of fructose (0.5 g/kg), fructose:glucose 1:1 (1 g/kg) or fructose:glucose 1:1 (2 g/kg). Our hypotheses are that the synthesis of palmitate from dietary fructose will be 1) greater when consumed with glucose and 2) show a dose-response. The lipogenic responses will be compared and correlated with markers of carbohydrate and lipid flux measured after fasting and post-fructose. The results will serve as a guide to the development of a new outpatient probe of the de novo lipogenic pathway in subjects who vary in their lipogenic response to oral fructose. These studies should ultimately yield valuable new information about the mechanisms linking dietary carbohydrate to elevated triglycerides, diabetes and cardiovascular disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females, 18-75 years of age
- Body mass index (BMI) 25-35 and within 10% of maximum weight
- Willing and able to stop fish oil, psyllium, other non-prescribed vitamins/supplements for 1 week prior to study until completion of study
- Willing to not drink alcohol for 24 h before each day of blood sampling
Key exclusion criteria (11 listed)
- Diabetes or other endocrine disorder, hepatitis or other liver disorder, HIV, or autoimmune disease
- Medication(s) known to affect lipids, including hormonal contraceptives
- Recent acute illness
- Gastrointestinal disease resulting in significant GI dysfunction or malabsorption
- History of fasting TG >800 mg/dl
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 |
|---|---|---|
| FructoseFructose, 0.5 g/kg | Dietary supplement | – |
| Fructose and GlucoseFructose:Glucose 1:1, 1 g/kg | Dietary supplement | – |
| Fructose and GlucoseFructose:Glucose 1:1, 2g/kg | Dietary supplement | – |
Primary outcome
A comparison of the iAUC in VLDL TG palmitate 4 hours after F:G1:1, 1g/kg, vs. 1) fructose 0.5g/kg, and 2) F:G:1:1, 2g/kg.
1 secondary outcome
Linear regression analysis of the relationship between the iAUC in VLDL TG palmitate after oral fructose and markers of carbohydrate and lipid flux
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 23 Sep 2013.
- 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.
Related trials for Elevated Triglycerides
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Hypertriglyceridemia, Severe Hypertriglyceridemia
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fructose and Fructose and Glucose in people with Elevated Triglycerides and Diabetes, 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 4 inclusion and 11 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 23 Sep 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
A comparison of the iAUC in VLDL TG palmitate 4 hours after F:G1:1, 1g/kg, vs. 1) fructose 0.5g/kg, and 2) F:G:1:1, 2g/kg.. 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 NCT00535535, 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 23 Sep 2013.