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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK067561 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to determine the effect of meal size and texture on the levels of incretin hormone, GLP-1, after Gastric Bypass Surgery (GBP). Patterns of food intake change after bariatric surgery and patients often eat multiple small low-calorie meals, a pattern that may affect blood glucose as well as incretin levels. Whether the release of GLP-1 after an oral challenge or a single liquid meal has any physiological relevance in 'real life' setting of multiple small meals diet is unclear.
The main goal is to study the effect of meal size and texture on incretin levels after GBP. Patients will be studied before GBP (T0) and 12-15 months after GBP (T1). At T0 and T1, patients will come for 2 study days for 8 hours: On one study day, a single meal will be served, on the second study day, three small meals, with the order of the conditions randomly assigned. The total amount of calories (600 kcal) and the over all nutrient composition (55% CHO, 15 % protein, 30% fat) will be equivalent between conditions. The meals will be either all solid or all liquid. Patients enrolled in the study will be randomly assigned to solid or liquid test meals.
Recruitment and data gathering for this study were performed at St. Luke's Hospital in New York, NY. Data Analysis was performed at Columbia University Medical Center in New York, NY.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solid Meal Study Group A | Other | Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as one, 600 kcal, meal. |
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| Liquid Meal Study Group A | Other | Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as one, 600 kcal, meal |
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| Solid Meal Study Group B | Other | Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as three, 200 kcal, meals. |
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| Liquid Meal Study Group B | Other | Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as three, 200 kcal, meals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solid Meal | Other | Subjects will receive solid meals during meal study |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in GLP-1 levels before and after gastric bypass surgery | Investigators will assess GLP-1 levels in subjects pre and post-GBP | 12-15 months |
| Difference in glucose levels before and after gastric bypass surgery | Investigators will assess glucose in subjects pre and post-GBP | 12-15 months |
| Difference in insulin levels before and after gastric bypass surgery | Investigators will assess insulin levels in subjects pre and post-GBP | 12-15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in GLP-1 levels in solid vs liquid meals | Investigators will assess GLP-1 levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points | 12-15 months |
| Difference in glucose levels in solid vs liquid meals |
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Inclusion Criteria: morbidly obese individuals, BMI above 35 and less than 50 kg/m2 who chose GBP as treatment for their obesity
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Blandine Laferrere, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center | New York | New York | 10025 | United States |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D012847 | Single Person |
| D062407 | Meals |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Liquid Meal | Other | Subjects will receive liquid meals, during meal study |
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| Acetaminophen | Drug | All subjects given acetaminophen to measure gastric emptying |
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| Single, 600 kcal meal | Other | Subjects will receive a single, 600 kcal meal during meal study |
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| Multiple, 200 kcal meals | Other | Subjects will receive three, 200 kcal meals, during meal study |
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Investigators will assess glucose levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points |
| 12-15 months |
| Difference in insulin levels in solid vs liquid meals | Investigators will assess insulin levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points | 12-15 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |