Change of Fructose to Fat in South Asians
This study is currently recruiting participants.
Verified April 2013 by The Rogosin Institute
Sponsor:
The Rogosin Institute
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
The Rogosin Institute
ClinicalTrials.gov Identifier:
NCT01562782
First received: March 22, 2012
Last updated: April 23, 2013
Last verified: April 2013
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Elevated Triglycerides Diabetes Cardiovascular Disease Dyslipidemia |
Other: Fructose + Glucose Beverage |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Fructose-induced Hepatic De Novo Lipogenesis in South Asians |
Resource links provided by NLM:
Further study details as provided by The Rogosin Institute:
Primary Outcome Measures:
- De novo lipogenesis [ Time Frame: 4 hours ] [ Designated as safety issue: No ]Difference from baseline in plasma VLDL TG %palmitate between South Asians and Caucasians 4 hours after an oral challenge of fructose:glucose, 1:1
Secondary Outcome Measures:
- Biomarkers in South Asians and Caucasians [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- To compare markers of carbohydrate and fatty acid metabolism, i.e. VLDL and total TG, cholesterol, apolipoprotein B, free fatty acids, insulin, glucose, fructose, lactate and glucose-dependent insulinotropic polypeptide (GIP, a marker of gastric emptying).
- To correlate these markers with the increase in VLDL TG palmitate.
| Estimated Enrollment: | 36 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fructose + Glucose Beverage
The arm is an oral sugar challenge with blood sampling over 4 hours.
|
Other: Fructose + Glucose Beverage
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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 OGTT < 140 mg/dL.
- TG <200 mg/dL, HDL cholesterol >30 mg/dL, LDL cholesterol <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.
Exclusion Criteria:
- 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 GI dysfunction or malabsorption.
- Cigarette smoking
- History of ethanol abuse (current intake >2 drinks/day) or illicit drugs.
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562782
Contacts
| Contact: Nancy Olowo | 646-962-8313 | nao2012@med.cornell.edu |
| Contact: Lisa Hudgins, MD | 212-570-3448 | lih2013@nyp.org |
Locations
| United States, New York | |
| Weill Cornell Medical College Clinical and Translational Science Center (CTSC) | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Nancy Olowo 646-962-8313 nao2012@med.cornell.edu | |
| The Rogosin Institute | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Lisa Hudgins, MD 212-570-3448 lih2013@nyp.org | |
Sponsors and Collaborators
The Rogosin Institute
Weill Medical College of Cornell University
Investigators
| Principal Investigator: | Lisa Hudgins, MD | The Rogosin Institute |
More Information
No publications provided
| Responsible Party: | The Rogosin Institute |
| ClinicalTrials.gov Identifier: | NCT01562782 History of Changes |
| Other Study ID Numbers: | 1110011995 |
| Study First Received: | March 22, 2012 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Rogosin Institute:
|
Elevated triglycerides Diabetes Mellitus Dyslipidemia Lipid Metabolic Disorders Body Weight |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Diabetes Mellitus Hypertriglyceridemia Dyslipidemias Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Hyperlipidemias Lipid Metabolism Disorders |
ClinicalTrials.gov processed this record on May 23, 2013