Facilitated Release of Endogenous Enterokines

NCT ID: NCT04215328

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-01
• Study Completion Date: 2019-02-28

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Mixed-Meal

Ensure Nutrition Shake

Group Type: EXPERIMENTAL

Mixed-Meal

Intervention Type: 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

Electrolyte Solution

Pedialyte Solution

Group Type: PLACEBO_COMPARATOR

Electrolyte Solution

Intervention Type: DIETARY_SUPPLEMENT

Electrolyte Solution 500mLs by tube daily in 4 doses

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Electrolyte Solution

Electrolyte Solution 500mLs by tube daily in 4 doses

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Halyard Health

INDUSTRY

Sponsor Role: collaborator

Wallace H. Coulter Foundation

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Beale

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Beale, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California, Keck School of Medicine

Locations

Roybal Diabetes Management Clinic

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32555148 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

USC HS-13-00748

Identifier Type: -

Identifier Source: org_study_id