Elevated TriglyceridesNCT01562782
Change of Fructose to Fat in South Asians
A study testing Fructose + Glucose Beverage in people with Elevated Triglycerides and Diabetes, run by The Rogosin Institute at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether hepatic de novo lipogenesis (DNL) in response to the ingestion of a mixture of glucose and fructose is greater in South Asians compared to controls (Caucasians). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Elevated Triglycerides, Diabetes, Cardiovascular Disease
- What is being tested?
- Fructose + Glucose Beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Apr 2012to 10 Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females, 18-35 years of age.
- South Asian or Caucasian descent through self-identification (South Asians are to have both biological parents with ancestry from India, Pakistan, Sri Lanka, Nepal and Bangladesh and no known non-South Asian ancestry in parents; Caucasians are to have both biological parents who self-identify as Caucasian and no known non-Caucasian ancestry in parents).
- Body mass index (BMI) 18.0-24.9 kg/m2 with no history of obesity.
- Fasting glucose <100 mg/dL, 2h glucose oral glucose tolerance test (OGTT) < 140 mg/dL.
- triglycerides (TG) <200 mg/dL, HDL cholesterol (HDL-C) >30 mg/dL, LDL cholesterol (LDL-C) <160 mg/dL.
- Willing and able to stop fish oil, fiber supplement, other non-prescribed vitamins/supplements for 1 week prior to visit #2 until completion of study.
- Willing to not drink alcohol for 24-hours before visit #2.
- Willing and able to provide informed consent.
Who cannot join
- History of 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 gastrointestinal dysfunction or malabsorption.
- Cigarette smoking
- History of ethanol abuse (current intake >2 drinks/day) 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
2 sites in 1 country.
United States2 sites
The Rogosin Institute
New York, New York, 10065
Weill Cornell Medical College Clinical and Translational Science Center (CTSC)
New York, New York, 10065
About this study
Official title: Fructose-induced Hepatic De Novo Lipogenesis in South Asians
The purpose of this study is to determine whether hepatic de novo lipogenesis (DNL) in response to the ingestion of a mixture of glucose and fructose is greater in South Asians compared to controls (Caucasians).
Read the detailed description
South Asians, who originate from the Indian subcontinent and make up one-fifth of the world's population, are among the highest number who suffer from heart disease and diabetes. The results of many research studies suggest that genes play a role in developing heart disease and diabetes that is made worse by the diet in the United States. Fructose is a sugar widely used in the American diet, and when consumed, it is taken up by the liver and changed into fats through a process called de novo lipogenesis (DNL). The current study will compare this change into fats in the liver between South Asians and Caucasians. The participants will be screened on the initial visit, and on the second visit, the DNL response will be measured in the blood over four hours after drinking one sweetened beverage, containing half glucose, half fructose, similar to a soft drink. We expect that DNL in response to fructose intake is higher in South Asians when compared to Caucasians and may partially explain why South Asians have earlier heart disease and diabetes.
- Conditions
- Elevated Triglycerides, Diabetes, Cardiovascular Disease, Dyslipidemia
- Being tested
- Fructose + Glucose Beverage
- Keywords
- Elevated triglycerides, Diabetes Mellitus, Dyslipidemia, Lipid Metabolic Disorders, Body Weight
- Medical subject headings
- Hypertriglyceridemia, Diabetes Mellitus, Cardiovascular Diseases, Dyslipidemias, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fructose + Glucose BeverageOther
Consumption of a sweet beverage (Fructose:Glucose 1:1, 3g/kg) over 1/2 hour. Blood sampling will occur before and after consumption of beverage.
| Study group | Role | What they receive |
|---|---|---|
| South Asians | Experimental | Participants in this group have only South Asian heritage. The intervention is Fructose + Glucose Beverage. Receives: Other: Fructose + Glucose Beverage |
| Caucasians | Active comparator | Participants in this group have only Caucasian heritage. The intervention is Fructose + Glucose Beverage. Receives: Other: Fructose + Glucose Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold Change in Plasma Very Low Density Lipoprotein (VLDL) Triglyceride Palmitate
Fold change in plasma very low density lipoprotein (VLDL) triglyceride palmitate between South Asians and Caucasians from baseline to 4 hours after an oral challenge of fructose:glucose, 1:1.
Measured: 4 hours
Secondary outcomes (9)
Fold Changes in VLDL Triglycerides in South Asians and Caucasians
- A comparison of the fold changes in very low density lipoprotein triglycerides (VLDL TG)in the 2 study groups between 0 and 4 hours.
Measured: 4 hours
Peak Glucose Levels in 2 Study Groups
A comparison of peak levels of glucose at one hour. Glucose is expected to increase after ingestion of glucose/fructose.
Measured: 1 hour
Peak Insulin Levels in 2 Study Groups
A comparison of the mean peak insulin level at one hour in each group. Insulin is expected to increase after ingestion of glucose/fructose.
Measured: 1 hour
Peak Gastric Inhibitory Protein (GIP) Levels in the 2 Study Groups
A comparison of the mean peak gastric inhibitory protein (GIP) at 2 hours in each group. GIP is expected to increase after ingestion of glucose/fructose.
Measured: 2 hours
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
Correlations between fold change in VLDL TG palmitate at 4 hours with other biomarkers of carbohydrate and fat metabolism in each study group.
Measured: 4 hours
Fold Changes in Triglycerides in 2 Study Groups
- A comparison of the fold changes in total triglycerides (TG) in the 2 study groups between 0 and 4 hours.
Measured: 4 hours
Peak Lactate Levels in 2 Study Groups
A comparison of peak levels of lactate (at one hour). Lactate is expected to increase after ingestion of glucose/fructose.
Measured: 1 hour
Nadir Non-esterified Fatty Acids (NEFA) Levels in 2 Study Groups
A comparison of the nadir level of non-esterified fatty acids (NEFA at 2 hours). NEFA are expected to decrease.
Measured: 2 hours
Peak Glucose in 2 Study Groups
A comparison of peak levels of glucose at 1 hour. Glucose is expected to increase after ingestion of glucose/fructose.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study start2 Apr 2012
- Primary completion10 Oct 2013
- Study completion10 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Rogosin Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Lisa Hudgins, MD, Principal investigator, The Rogosin Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562782
- Sponsor's protocol ID
- 1110011995
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2012
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fructose-induced Hepatic De Novo Lipogenesis in South Asians
- ClinicalTrials.gov ID
- NCT01562782
- Acronym / sponsor ID
- 1110011995
- Conditions
- Elevated Triglycerides, Diabetes, Cardiovascular Disease, Dyslipidemia
- Keywords
- Elevated triglycerides, Diabetes Mellitus, Dyslipidemia, Lipid Metabolic Disorders, Body Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- The Rogosin InstituteUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- 2 Apr 2012 (actual)
- Primary completion
- 10 Oct 2013 (actual)
- Study completion
- 10 Oct 2013 (actual)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Posted 19 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether hepatic de novo lipogenesis (DNL) in response to the ingestion of a mixture of glucose and fructose is greater in South Asians compared to controls (Caucasians).
Detailed description
South Asians, who originate from the Indian subcontinent and make up one-fifth of the world's population, are among the highest number who suffer from heart disease and diabetes. The results of many research studies suggest that genes play a role in developing heart disease and diabetes that is made worse by the diet in the United States. Fructose is a sugar widely used in the American diet, and when consumed, it is taken up by the liver and changed into fats through a process called de novo lipogenesis (DNL). The current study will compare this change into fats in the liver between South Asians and Caucasians. The participants will be screened on the initial visit, and on the second visit, the DNL response will be measured in the blood over four hours after drinking one sweetened beverage, containing half glucose, half fructose, similar to a soft drink. We expect that DNL in response to fructose intake is higher in South Asians when compared to Caucasians and may partially explain why South Asians have earlier heart disease and diabetes.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| South Asians | Experimental | Other: Fructose + Glucose BeverageParticipants in this group have only South Asian heritage. The intervention is Fructose + Glucose Beverage. |
| Caucasians | Active comparator | Other: Fructose + Glucose BeverageParticipants in this group have only Caucasian heritage. The intervention is Fructose + Glucose Beverage. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males and females, 18-35 years of age.
- South Asian or Caucasian descent through self-identification (South Asians are to have both biological parents with ancestry from India, Pakistan, Sri Lanka, Nepal and Bangladesh and no known non-South Asian ancestry in parents; Caucasians are to have both biological parents who self-identify as Caucasian and no known non-Caucasian ancestry in parents).
- Body mass index (BMI) 18.0-24.9 kg/m2 with no history of obesity.
- Fasting glucose <100 mg/dL, 2h glucose oral glucose tolerance test (OGTT) < 140 mg/dL.
- triglycerides (TG) <200 mg/dL, HDL cholesterol (HDL-C) >30 mg/dL, LDL cholesterol (LDL-C) <160 mg/dL.
Key exclusion criteria (11 listed)
- History of 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 gastrointestinal dysfunction or malabsorption.
- Cigarette smoking
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 |
|---|---|---|
| Fructose + Glucose BeverageConsumption of a sweet beverage (Fructose:Glucose 1:1, 3g/kg) over 1/2 hour. Blood sampling will occur before and after consumption of beverage. | Other | Caucasians, South Asians |
Primary outcome
Fold Change in Plasma Very Low Density Lipoprotein (VLDL) Triglyceride Palmitate
Time frame: 4 hours
Fold change in plasma very low density lipoprotein (VLDL) triglyceride palmitate between South Asians and Caucasians from baseline to 4 hours after an oral challenge of fructose:glucose, 1:1.
9 secondary outcomes
Fold Changes in VLDL Triglycerides in South Asians and Caucasians
Time frame: 4 hours
Peak Glucose Levels in 2 Study Groups
Time frame: 1 hour
Peak Insulin Levels in 2 Study Groups
Time frame: 1 hour
Peak Gastric Inhibitory Protein (GIP) Levels in the 2 Study Groups
Time frame: 2 hours
Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
Time frame: 4 hours
Fold Changes in Triglycerides in 2 Study Groups
Time frame: 4 hours
Peak Lactate Levels in 2 Study Groups
Time frame: 1 hour
Nadir Non-esterified Fatty Acids (NEFA) Levels in 2 Study Groups
Time frame: 2 hours
Peak Glucose in 2 Study Groups
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 Hudgins, MD principal investigator
The Rogosin Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructose + Glucose Beverage in people with Elevated Triglycerides and Diabetes, run by The Rogosin Institute at 2 sites 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 8 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 19 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fold Change in Plasma Very Low Density Lipoprotein (VLDL) Triglyceride Palmitate (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.