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NCT Number: NCT02762708

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Body Weight Changes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Bariatric Surgery

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.

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.

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.

Primary outcomes

  1. Fasting Glucose

    Time frame: At baseline and 12 weeks post intervention

    Blood sample taken after an overnight fast.

  2. Fasting Glucose

    Time frame: 4 weeks post intervention

    Blood sample taken after an overnight fast.

  3. Peak Glucose

    Time frame: baseline and 12 weeks post intervention

    Blood sample taken after a meal.

  4. Peak Glucose

    Time frame: 4 weeks post intervention

    Blood sample taken after a meal.

  5. Glucose AUC

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

    Area under the curve calculated from Oral Glucose Tolerance Test

  6. Changes in the Gut Microbiome Following RYGB or Caloric Restriction

    Time frame: baseline and 12 weeks post intervention

    Stool sample collection for gut microbiome analysis

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: Microbiome

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 5, 2016
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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