Facilitated Release of Endogenous Enterokines

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT04215328

Run by

University of Southern California

People needed

16

Starts

2014-11-01

Expected to finish

2019-02-28

Last updated by the study team

2020-01-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetes on oral antidiabetic medication
• BMI greater than or equal to 30kg/m2
• A1C less than 9%

You may not qualify if…

• 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.

Where it is running

• Roybal Diabetes Management Clinic — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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