Diabetes Mellitus, Type 2
Conditions
Keywords
Obesity, Diabetes Mellitus, Type 2, Nutrient
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTMixed-Meal
Per 250ml bottle: 220 calories, protein 9g, carbohydrate 33g (15g sugar), fat 6g, sodium 190mg, potassium 390mg; 500mLs by tube daily in 4 doses
DIETARY_SUPPLEMENTElectrolyte Solution
Electrolyte Solution 500mLs by tube daily in 4 doses
Sponsors
Halyard Health
Wallace H. Coulter Foundation
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes on oral antidiabetic medication * BMI greater than or equal to 30kg/m2 * A1C less than 9%
Exclusion criteria
* Use of any of the following medications: dipeptide-peptidase IV (DPP-IV) inhibitors (e.g., sitagliptin), GLP-1 analogs (e.g., exenatide) or medication that could alter glucose tolerance (e.g. steroids) * Contraindication to tube (e.g. Prior upper gastrointestinal bleed, or history of easy bleeding, altered foregut anatomy due to obstruction or surgery) * Known cardiovascular disease other than controlled hypertension. * Pregnancy or unwilling to take contraception * Active esophagitis * Known hiatal hernia * Active gastric ulcer and/or duodenal ulcers, * Previous restrictive surgery of the gastrointestinal tract * Crohn's disease * Active cancer * History of gastrointestinal hemorrhage * Known upper gastrointestinal lesions with potential to bleed * Use of NSAIDs or anticoagulants * Psychiatric disorders other than mild depression * Likely inability to adhere to study protocol including alcohol or drug dependent patients * Type I diabetes, * Liver, kidney or multi-organ dysfunction. * Known eating disorders * Inability to attend scheduled or unanticipated study visits * Known prior abdominal problems or operations that could lead to adhesions or strictures and that could prevent the spontaneous passage of a 10 French jejunal tube if it were to dislodge distally.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight change between groups | Day 0 to Day 14 | Weight measured in kilograms taken before and immediately following the intervention period between the intervention and control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight change within group | Day 0 to Day 14 | Weight measured in kilgrams. Within group |
| Change in waist and hip measurements | Day 0 to Day 14 | Measured in centimeters. Between groups. |
| Caloric intake within and between groups | Day 0 to Day 14 | Caloric intake measured in kcal. Determined by consumption of provided food. |
| Change in heart rate | Day 0 to Day 14 | Measured in beats per minute. Between groups. |
| Changes in gut hormone levels | Day 0 to Day 14 | Including GLP-1, PYY, CCK, C-peptide, and insulin. Between groups. |
| Change in systolic and diastolic blood pressure | Day 0 to Day 14 | Measured in mmHg for both. Between groups. |
Countries
United States
Outcome results
None listed