The Effect of Bariatric Surgery on Metabolism, the Metabolome and Microbiome in Patients With Type 2 Diabetes

NCT02762708 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 15-000179
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2 diabetes outside of weight loss alone?

Conditions

Type 2 Diabetes Mellitus; Obesity

Keywords

Bariatric Surgery; Weight loss

Outcome Measures

Primary Outcomes (6)

• Fasting Glucose

  Blood sample taken after an overnight fast.

  At baseline and 12 weeks post intervention

• Fasting Glucose

  Blood sample taken after an overnight fast.

  4 weeks post intervention

• Peak Glucose

  Blood sample taken after a meal.

  baseline and 12 weeks post intervention

• Peak Glucose

  Blood sample taken after a meal.

  4 weeks post intervention

• Glucose AUC

  Area under the curve calculated from Oral Glucose Tolerance Test

  0 to 360 minutes post-meal at Baseline and 12 weeks post-intervention

• Changes in the Gut Microbiome Following RYGB or Caloric Restriction

  Stool sample collection for gut microbiome analysis

  baseline and 12 weeks post intervention

Study Arms (4)

Roux-en-Y Gastric Bypass (RYGB)

ACTIVE COMPARATOR

Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB.

Procedure: Roux-en-Y Gastric Bypass (RYGB)

Caloric restriction

SHAM COMPARATOR

Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery.

Behavioral: Caloric Restriction

Exendin-9,39

ACTIVE COMPARATOR

Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.

Drug: Exendin-9,39

Normal Saline

PLACEBO COMPARATOR

Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.

Drug: Normal Saline

Interventions

Roux-en-Y Gastric Bypass (RYGB) PROCEDURE

Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery.

Also known as: Bariatric Surgery

Roux-en-Y Gastric Bypass (RYGB)

Caloric Restriction BEHAVIORAL

Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician.

Caloric restriction

Exendin-9,39 DRUG

A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.

Exendin-9,39

Normal Saline DRUG

subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.

Normal Saline

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-65 years of age.
• Seen at Mayo Clinic Nutrition Clinic and have received authorization for RYGB surgery.
• Type 2 Diabetes Mellitus or impaired fasting glucose with BMI \>35 AND not interested in surgery but are interested in supervised caloric restriction.

You may not qualify if:

• Previous treatment with thiazolidinediones.
• Chronic antibiotic therapy.
• Active microvascular or macrovascular complications of diabetes.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Weight Loss

Interventions

Gastric Bypass; Bariatric Surgery; Caloric Restriction; Saline Solution

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures; Diet Therapy; Nutrition Therapy; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Only one patient was enrolled in the trial period 'Study 2-Exendin (9,39) Amide study' 4 weeks post operatively. There were logistical challenges to recruiting patients 4 weeks post operatively as operation dates were not always known to the study team in time and patients did not feel well enough to come in for a study.

Results Point of Contact

• Title: Meera Shah, MB, ChB
• Organization: Mayo Clinic

Shah.Meera@mayo.edu

507-284-0106

Study Officials

• Meera Shah, MBChB

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 5, 2016
• Study Start: March 1, 2016
• Primary Completion: January 6, 2018
• Study Completion: January 6, 2018
• Last Updated: May 3, 2022
• Results First Posted: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)