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Facilitated Release of Endogenous Enterokines (F2G)

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mixed-Meal

Electrolyte Solution

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring Obesity, Diabetes Mellitus, Type 2, Nutrient

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Roybal Diabetes Management Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mixed-Meal

Electrolyte Solution

Arm Description

Ensure Nutrition Shake

Pedialyte Solution

Outcomes

Primary Outcome Measures

Weight change between groups

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

Caloric intake measured in kcal. Determined by consumption of provided food.

Weight change within group

Weight measured in kilgrams. Within group

Change in waist and hip measurements

Measured in centimeters. Between groups.

Change in systolic and diastolic blood pressure

Measured in mmHg for both. Between groups.

Change in heart rate

Measured in beats per minute. Between groups.

Changes in gut hormone levels

Including GLP-1, PYY, CCK, C-peptide, and insulin. Between groups.

Full Information

NCT ID

NCT04215328

First Posted

December 26, 2019

Last Updated

January 2, 2020

Sponsor

University of Southern California

Collaborators

Halyard Health, Wallace H. Coulter Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04215328

Brief Title

Facilitated Release of Endogenous Enterokines

Acronym

F2G

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

November 1, 2014 (Actual)

Primary Completion Date

February 28, 2019 (Actual)

Study Completion Date

February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Southern California

Collaborators

Halyard Health, Wallace H. Coulter Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Obesity, Diabetes Mellitus, Type 2, Nutrient

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mixed-Meal

Arm Type

Experimental

Arm Description

Ensure Nutrition Shake

Arm Title

Electrolyte Solution

Arm Type

Placebo Comparator

Arm Description

Pedialyte Solution

Intervention Type

Dietary Supplement

Intervention Name(s)

Mixed-Meal

Other Intervention Name(s)

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

Intervention Description

Per 250ml bottle: 220 calories, protein 9g, carbohydrate 33g (15g sugar), fat 6g, sodium 190mg, potassium 390mg; 500mLs by tube daily in 4 doses

Intervention Type

Dietary Supplement

Intervention Name(s)

Electrolyte Solution

Other Intervention Name(s)

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

Intervention Description

Electrolyte Solution 500mLs by tube daily in 4 doses

Primary Outcome Measure Information:

Title

Weight change between groups

Description

Weight measured in kilograms taken before and immediately following the intervention period between the intervention and control group

Time Frame

Day 0 to Day 14

Secondary Outcome Measure Information:

Title

Caloric intake within and between groups

Description

Caloric intake measured in kcal. Determined by consumption of provided food.

Time Frame

Day 0 to Day 14

Title

Weight change within group

Description

Weight measured in kilgrams. Within group

Time Frame

Day 0 to Day 14

Title

Change in waist and hip measurements

Description

Measured in centimeters. Between groups.

Time Frame

Day 0 to Day 14

Title

Change in systolic and diastolic blood pressure

Description

Measured in mmHg for both. Between groups.

Time Frame

Day 0 to Day 14

Title

Change in heart rate

Description

Measured in beats per minute. Between groups.

Time Frame

Day 0 to Day 14

Title

Changes in gut hormone levels

Description

Including GLP-1, PYY, CCK, C-peptide, and insulin. Between groups.

Time Frame

Day 0 to Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth Beale, MD

Organizational Affiliation

University of Southern California, Keck School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Roybal Diabetes Management Clinic

City

Los Angeles

State/Province

California

ZIP/Postal Code

90022

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32555148

Citation

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.

Results Reference

derived

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Facilitated Release of Endogenous Enterokines

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