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| Name | Class |
|---|---|
| Halyard Health | INDUSTRY |
| Wallace H. Coulter Foundation | OTHER |
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The overall objective is to develop therapy for obesity and diabetes that is as effective as gastric bypass surgery but without the cost and safety concerns.
Gastric bypass leads to rapid, sustained diabetes remission in the majority of patients who undergo this procedure and is also highly effective therapy for obesity. However, currently <1% of medically-eligible patients undergo this or other bariatric operations due to cost and safety concerns. The approach is based on data suggesting that the benefit of gastric bypass is largely due to anatomical rearrangement of the intestine which leads to accelerated delivery of nutrients to the jejunum. This rerouting of nutrients stimulates the release of multiple neural, hormonal and enterokine responses that are associated with appetite suppression and improved glucose control. In this pilot proposal the question under investigation is whether repeated rapid delivery of a mixed meal directly to the jejunum can promote weight loss and glucose control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mixed-Meal | Experimental | Ensure Nutrition Shake |
|
| Electrolyte Solution | Placebo Comparator | Pedialyte Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mixed-Meal | Dietary Supplement | Per 250ml bottle: 220 calories, protein 9g, carbohydrate 33g (15g sugar), fat 6g, sodium 190mg, potassium 390mg; 500mLs by tube daily in 4 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight change between groups | Weight measured in kilograms taken before and immediately following the intervention period between the intervention and control group | Day 0 to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Caloric intake within and between groups | Caloric intake measured in kcal. Determined by consumption of provided food. | Day 0 to Day 14 |
| Weight change within group | Weight measured in kilgrams. Within group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Beale, MD | University of Southern California, Keck School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roybal Diabetes Management Clinic | Los Angeles | California | 90022 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32555148 | Derived | Beale EO, Lee W, Lee A, Lee C, Soffer E, Crookes PF, Eagilen K, Chen R, Mack WJ, Tong H. Effect of bolus enteral tube feeding on body weight in ambulatory adults with obesity and type 2 diabetes: a feasibility pilot randomized trial. Nutr Diabetes. 2020 Jun 17;10(1):22. doi: 10.1038/s41387-020-0125-6. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2014 | Dec 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Electrolyte Solution | Dietary Supplement | Electrolyte Solution 500mLs by tube daily in 4 doses |
|
|
| Day 0 to Day 14 |
| Change in waist and hip measurements | Measured in centimeters. Between groups. | Day 0 to Day 14 |
| Change in systolic and diastolic blood pressure | Measured in mmHg for both. Between groups. | Day 0 to Day 14 |
| Change in heart rate | Measured in beats per minute. Between groups. | Day 0 to Day 14 |
| Changes in gut hormone levels | Including GLP-1, PYY, CCK, C-peptide, and insulin. Between groups. | Day 0 to Day 14 |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |