Facilitated Release of Endogenous Enterokines (F2G)

University of Southern California

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Dietary Supplement: Electrolyte Solution

Dietary Supplement: Mixed-Meal

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04215328

USC HS-13-00748

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.