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

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Mayo Clinic

Status and phase

Completed
Phase 2

Conditions

Type 2 Diabetes Mellitus
Obesity

Treatments

Procedure: Roux-en-Y Gastric Bypass (RYGB)
Drug: Exendin-9,39
Behavioral: Caloric Restriction
Drug: Normal Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT02762708
15-000179

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12 participants in 4 patient groups, including a placebo group

Roux-en-Y Gastric Bypass (RYGB)
Active Comparator group
Description:
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.
Treatment:
Procedure: Roux-en-Y Gastric Bypass (RYGB)
Caloric restriction
Sham Comparator group
Description:
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.
Treatment:
Behavioral: Caloric Restriction
Exendin-9,39
Active Comparator group
Description:
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.
Treatment:
Drug: Exendin-9,39
Normal Saline
Placebo Comparator group
Description:
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.
Treatment:
Drug: Normal Saline

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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