Change of Fructose to Fat in South Asians

This study is currently recruiting participants.
Verified November 2013 by The Rogosin Institute
Sponsor:
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: November 8, 2013
Last verified: November 2013
  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 ]
    1. 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).
    2. To correlate these markers with the increase in VLDL TG palmitate.


Estimated Enrollment: 36
Study Start Date: March 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (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 646-317-0805 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    646-317-0805    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: November 8, 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 April 23, 2014