Facilitated Release of Endogenous Enterokines (F2G)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: Mixed-Meal; Dietary supplement: Electrolyte Solution

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90022
      • Roybal Diabetes Management Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Wallace H. Coulter Foundation; Halyard Health
• Investigators: Principal Investigator: Elizabeth Beale, MD, University of Southern California, Keck School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: December 26, 2019
• First Submitted That Met QC Criteria: December 29, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Obesity; Diabetes Mellitus, Type 2; Nutrient
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: USC HS-13-00748

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No