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| Name | Class |
|---|---|
| Cornell University | OTHER |
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The purpose of this study is to test the relationship between frequency of meals and hepatic fat content and insulin sensitivity. We, the researchers at Rockefeller University, hypothesize that low plasma insulin levels (as achieved by periods of fasting) will prevent insulin resistance and reduce hepatic lipid content. In contrast, frequent, carbohydrate-rich meals will predispose to hepatic steatosis (non-alcoholic) and insulin resistance.
This is a 6 week inpatient study.
The hypothesis will be tested by studying two groups of normal subjects who will receive a defined weight maintenance diet: one group will be given meals twice a day and other group will be given eight meals (snacks) per day. At the beginning of the study period and after 4 weeks following the specified frequency of meals, the study subjects will have their whole body insulin sensitivity and hepatic fat content measured by the euglycemic-hyperinsulinemic clamp and MRI of the liver, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high frequency meals group | Active Comparator | High carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks. |
|
| twice-a -day meals | Active Comparator | high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high frequency of meals | Other | high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| We will determine total body insulin sensitivity with the help of the hyperinsulinemic-euglycemic clamp. We will also assess hepatic steatosis by conducting MRI scans on our subjects. | days 8,9,11 41 and 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight, waist and hip circumference, fasting glucose and insulin, serum ketones, lipids and lipoproteins including VLDL and apolipoprotien B100, liver function tests, serum adiponectin (marker for insulin resistance), and measures of hunger. | days 1-42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Stoffel, MD, PHD | Rockefeller University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rockefeller University Hospital | New York | New York | 10021 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| twice a day meals | Other | high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks. |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |