Change of Fructose to Fat in South Asians

Diabetes Clinical Trial

Official title:

Fructose-induced Hepatic De Novo Lipogenesis in South Asians

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562782
• Other study ID #: 1110011995
• Status: Completed
• Phase: N/A
• Start date: April 2, 2012
• Est. completion date: October 10, 2013

Study information

• Verified date: March 2024
• Source: The Rogosin Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 10, 2013
• Est. primary completion date: October 10, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Dyslipidemia
• Dyslipidemias
• Elevated Triglycerides
• Hypertriglyceridemia

Intervention

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.

Locations

Country	Name	City	State
United States	The Rogosin Institute	New York	New York
United States	Weill Cornell Medical College Clinical and Translational Science Center (CTSC)	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
The Rogosin Institute	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 hours
Secondary	Fold Changes in VLDL Triglycerides in South Asians and Caucasians	1) A comparison of the fold changes in very low density lipoprotein triglycerides (VLDL TG)in the 2 study groups between 0 and 4 hours.	4 hours
Secondary	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.	1 hour
Secondary	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.	1 hour
Secondary	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.	2 hours
Secondary	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.	4 hours
Secondary	Fold Changes in Triglycerides in 2 Study Groups	1) A comparison of the fold changes in total triglycerides (TG) in the 2 study groups between 0 and 4 hours.	4 hours
Secondary	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.	1 hour
Secondary	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.	2 hours
Secondary	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.	1 hour