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Completed

NCT Number: NCT04215328

Facilitated Release of Endogenous Enterokines

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roybal Diabetes Management Clinic

Los Angeles, California, 90022, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mixed-Meal

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

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

Electrolyte Solution

Dietary Supplement

Electrolyte Solution 500mLs by tube daily in 4 doses

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

Primary outcomes

  1. Weight change between groups

    Time frame: Day 0 to Day 14

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

Secondary outcomes

  1. Caloric intake within and between groups

    Time frame: Day 0 to Day 14

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

  2. Weight change within group

    Time frame: Day 0 to Day 14

    Weight measured in kilgrams. Within group

  3. Change in waist and hip measurements

    Time frame: Day 0 to Day 14

    Measured in centimeters. Between groups.

  4. Change in systolic and diastolic blood pressure

    Time frame: Day 0 to Day 14

    Measured in mmHg for both. Between groups.

  5. Change in heart rate

    Time frame: Day 0 to Day 14

    Measured in beats per minute. Between groups.

  6. Changes in gut hormone levels

    Time frame: Day 0 to Day 14

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

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Halyard Health
  • Wallace H. Coulter Foundation

Registry information

Official study title

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

Acronym: F2G

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2020
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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