Clinical trial NCT01562782: Change of Fructose to Fat in South Asians
Official title: Fructose-induced Hepatic De Novo Lipogenesis in South Asians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elevated Triglycerides
Diabetes
Cardiovascular Disease
Dyslipidemia
Keywords: Elevated triglycerides
Diabetes Mellitus
Dyslipidemia
Lipid Metabolic Disorders
Body Weight
Lead sponsor: The Rogosin Institute
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2012-03-26
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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).

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 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 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.

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 gastrointestinal 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

Primary outcomes:
measure: Fold Change in Plasma Very Low Density Lipoprotein (VLDL) Triglyceride Palmitate
timeFrame: 4 hours
Secondary outcomes:
measure: Fold Changes in VLDL Triglycerides in South Asians and Caucasians
timeFrame: 4 hours
measure: Peak Glucose Levels in 2 Study Groups
timeFrame: 1 hour
measure: Peak Insulin Levels in 2 Study Groups
timeFrame: 1 hour
measure: Peak Gastric Inhibitory Protein (GIP) Levels in the 2 Study Groups
timeFrame: 2 hours
measure: Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism
timeFrame: 4 hours
measure: Fold Changes in Triglycerides in 2 Study Groups
timeFrame: 4 hours
measure: Peak Lactate Levels in 2 Study Groups
timeFrame: 1 hour
measure: Nadir Non-esterified Fatty Acids (NEFA) Levels in 2 Study Groups
timeFrame: 2 hours
measure: Peak Glucose in 2 Study Groups
timeFrame: 1 hour
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rogosin Institute
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College Clinical and Translational Science Center (CTSC)
state: New York
Study officials:
affiliation: The Rogosin Institute
name: Lisa Hudgins, MD
role: PRINCIPAL_INVESTIGATOR
References: