Facilitated Release of Endogenous Enterokines

Diabetes Mellitus, Type 2 Clinical Trial

— F2G  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04215328
• Other study ID #: USC HS-13-00748
• Status: Completed
• Phase: N/A
• Start date: November 1, 2014
• Est. completion date: February 28, 2019

Study information

• Verified date: January 2020
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• 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
• Electrolyte Solution
Electrolyte Solution 500mLs by tube daily in 4 doses

Locations

Country	Name	City	State
United States	Roybal Diabetes Management Clinic	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	Halyard Health, Wallace H. Coulter Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change between groups	Weight measured in kilograms taken before and immediately following the intervention period between the intervention and control group	Day 0 to Day 14
Secondary	Caloric intake within and between groups	Caloric intake measured in kcal. Determined by consumption of provided food.	Day 0 to Day 14
Secondary	Weight change within group	Weight measured in kilgrams. Within group	Day 0 to Day 14
Secondary	Change in waist and hip measurements	Measured in centimeters. Between groups.	Day 0 to Day 14
Secondary	Change in systolic and diastolic blood pressure	Measured in mmHg for both. Between groups.	Day 0 to Day 14
Secondary	Change in heart rate	Measured in beats per minute. Between groups.	Day 0 to Day 14
Secondary	Changes in gut hormone levels	Including GLP-1, PYY, CCK, C-peptide, and insulin. Between groups.	Day 0 to Day 14