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| Name | Class |
|---|---|
| Weill Medical College of Cornell University | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| South Asians | Experimental | Participants in this group have only South Asian heritage. The intervention is Fructose + Glucose Beverage. |
|
| Caucasians | Active Comparator | Participants in this group have only Caucasian heritage. The intervention is Fructose + Glucose Beverage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fructose + Glucose Beverage | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Peak Glucose Levels in 2 Study Groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Hudgins, MD | The Rogosin Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Rogosin Institute | New York | New York | 10065 | United States | ||
| Weill Cornell Medical College Clinical and Translational Science Center (CTSC) |
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At the CTSC clinic, consented volunteers had their medical history reviewed and a physical exam performed. A fasting blood sample was obtained to screen for lipid and biochemical abnormalities, thyroid and liver disease, anemia, pregnancy and diabetes/glucose intolerance.
Between 4/2012 and 10/2013 fifteen South Asians and 15 Caucasians were studied as outpatients at the Weill Cornell Medical College Clinical and Translational Science Center (CTSC).
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| ID | Title | Description |
|---|---|---|
| FG000 | Caucasians | Control group: The arm is an oral sugar challenge with blood sampling over 4 hours. 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. |
| FG001 | South Asians | South Asian group: The arm is an oral sugar challenge with blood sampling over 4 hours. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Caucasian | Control group: The arm is an oral sugar challenge with blood sampling over 4 hours. 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. |
| BG001 | South Asians |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | fold change | 4 hours |
|
|
4 hours per participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caucasians | Caucasian control group | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment | Mild nausea after ingestion of beverage in one subject. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Hudgins, M.D. | The Rogosin Institute | 646-317-0805 | lih2013@nyp.org |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| D003920 | Diabetes Mellitus |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005632 | Fructose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 |
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A comparison of peak levels of glucose at one hour. Glucose is expected to increase after ingestion of glucose/fructose. |
| 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. | 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. | 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. | 4 hours |
| 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 |
| 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 |
| 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 |
| 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 |
| New York |
| New York |
| 10065 |
| United States |
Experimental group: The arm is an oral sugar challenge with blood sampling over 4 hours. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | fold change | 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. | Posted | Mean | Standard Deviation | mmol/L | 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. | Posted | Mean | Standard Deviation | IU/L | 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. | Posted | Mean | Standard Deviation | ng/L | 2 hours |
|
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|
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| 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. | Posted | Number | r (correlation coefficient) | 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. | Posted | Mean | Standard Deviation | fold change | 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. | Posted | Mean | Standard Deviation | mmol/L | 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. | Posted | Mean | Standard Deviation | mmol/L | 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. | Posted | Mean | Standard Deviation | mmol/L | 1 hour |
|
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|
|
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | South Asians | South Asian experimental group | 0 | 15 | 0 | 15 | 1 | 15 |
|
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| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Ketoses |
| fold change VLDL TG palmitate 4h:total TG 0h |
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| fold change VLDL TG palmitat: fold change total TG |
|
| fold change VLDL TG palmitate 4h:cholesterol 0h |
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| fold change VLDL TG palmitat 4h:HDL cholesterol 0h |
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| fold change VLDL TG palmita 4h:apolipoprotein B 0h |
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| fold change VDLD TG palm 4h:LDL particle number 0h |
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| fold change VDLD TG palmitate 4h:LDL size 0h |
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| fold change VLDL TG palmitate 4h:glucose 0h |
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| fold change VDLD TG palmitate 4h:glucose AUC |
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| fold change VDLD TG palmitate 4h:insulin 0h |
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| fold change VDLD TG palmitate 4h:insulin AUC |
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| fold change VDLD TG palmitate 4h:NEFA 0h |
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| fold change VDLD TG palmitate 4h:NEFA nadir 2h |
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| fold change VDLD TG palmitate 4h:lactate 0h |
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| fold change VDLD TG palmitate 4h:lactate peak 1h |
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| fold change VDLD TG palmitate 4h:GIP 0h |
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| fold change VDLD TG palmitate 4h:GIP peak 2h |
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| fold change VDLD TG palmitate 4h:HOMA-R 0h |
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| fold change VDLD TG palmitate 4h:HOMA-B% 0h |
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| fold change VDLD TG palmitate 4h:hsCRP 0h |
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