F2G: Facilitated Release of Endogenous Enterokines

Sponsor

University of Southern California (Other)

Overall Status

Completed

CT.gov ID

NCT04215328

Collaborator

Halyard Health (Industry), Wallace H. Coulter Foundation (Other)

Enrollment

Location

Arms

51.9

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Dietary Supplement: Mixed-Meal Dietary Supplement: Electrolyte Solution	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Facilitated Release of Endogenous Enterokines: An Ambulatory Prospective Randomized Controlled Trial

Actual Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Feb 28, 2019

Actual Study Completion Date :

Feb 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mixed-Meal Ensure Nutrition Shake	Dietary Supplement: Mixed-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 Other Names: Ensure Nutrition Shake® (Abbott Park, Illinois, U.S.A.)
Placebo Comparator: Electrolyte Solution Pedialyte Solution	Dietary Supplement: Electrolyte Solution Electrolyte Solution 500mLs by tube daily in 4 doses Other Names: Unflavored Pedialyte ® (Abbott Park, Illinois, U.S.A.)

Arm

Intervention/Treatment

Experimental: Mixed-Meal

Ensure Nutrition Shake

Dietary Supplement: Mixed-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

Other Names:

Ensure Nutrition Shake® (Abbott Park, Illinois, U.S.A.)

Placebo Comparator: Electrolyte Solution

Pedialyte Solution

Dietary Supplement: Electrolyte Solution

Electrolyte Solution 500mLs by tube daily in 4 doses

Other Names:

Unflavored Pedialyte ® (Abbott Park, Illinois, U.S.A.)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Caloric intake within and between groups [Day 0 to Day 14]
Caloric intake measured in kcal. Determined by consumption of provided food.
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.
Change in systolic and diastolic blood pressure [Day 0 to Day 14]
Measured in mmHg for both. Between groups.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.