Clinical trial NCT04215328: Facilitated Release of Endogenous Enterokines
Official title: Facilitated Release of Endogenous Enterokines: An Ambulatory Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Obesity
Diabetes Mellitus, Type 2
Nutrient
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Halyard Health
name: Wallace H. Coulter Foundation
First posted: 2020-01-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Weight change between groups
timeFrame: Day 0 to Day 14
Secondary outcomes:
measure: Caloric intake within and between groups
timeFrame: Day 0 to Day 14
measure: Weight change within group
timeFrame: Day 0 to Day 14
measure: Change in waist and hip measurements
timeFrame: Day 0 to Day 14
measure: Change in systolic and diastolic blood pressure
timeFrame: Day 0 to Day 14
measure: Change in heart rate
timeFrame: Day 0 to Day 14
measure: Changes in gut hormone levels
timeFrame: Day 0 to Day 14
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Roybal Diabetes Management Clinic
state: California
Study officials:
affiliation: University of Southern California, Keck School of Medicine
name: Elizabeth Beale, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.