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

Obesity Clinical Trial

— Microbiome  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762708
• Other study ID #: 15-000179
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: January 6, 2018

Study information

• Verified date: April 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Roux-en-y gastric bypass (RYGB) surgery leads to improvements in diabetes that occurs even before any significant weight loss is seen. What are the reasons for this? There is evidence in animals that changes in the composition of gut bacteria after RYGB may be responsible for improvements in how glucose is metabolized in the body. The study aims to correlate changes in the bacterial composition of the gut that occurs after surgery with improvements in glucose metabolism in people with type 2 diabetes. The investigators will do this by using validated methods to measure glucose metabolism and cutting edge technology to analyze the gut microbiome. A parallel group of patients with similar weight, height and age will undergo caloric restriction alone to mimic weight loss seen after RYGB. Participants will also undergo similar glucose metabolism studies and analysis of their gut bacterial composition. Thus, any difference seen between groups can be attributed to the surgery itself and may lead to identification of novel therapeutic options for diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 6, 2018
• Est. primary completion date: January 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Previous treatment with thiazolidinediones.

• Chronic antibiotic therapy.

• Active microvascular or macrovascular complications of diabetes.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

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

Behavioral:
• Caloric Restriction
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.

Drug:
• Exendin-9,39
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.
• Normal Saline
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Glucose	Blood sample taken after an overnight fast.	At baseline and 12 weeks post intervention
Primary	Fasting Glucose	Blood sample taken after an overnight fast.	4 weeks post intervention
Primary	Peak Glucose	Blood sample taken after a meal.	baseline and 12 weeks post intervention
Primary	Peak Glucose	Blood sample taken after a meal.	4 weeks post intervention
Primary	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
Primary	Changes in the Gut Microbiome Following RYGB or Caloric Restriction	Stool sample collection for gut microbiome analysis	baseline and 12 weeks post intervention

External Links

•   Mayo Clinic Clinical Trials