A Study of the Metabolome and Microbiome Following Bariatric Surgery, and the Effect on Metabolism in Patients with Type 2 Diabetes

Overview

About this study

The purpose of this study is to identify changes to the metabolome (range of chemicals produced in the body) and microbiome (intestine microbe environment) that are unique to Roux-en-Y gastric bypass surgery and assess the associated effect on the metabolism of patients with type 2 diabetes.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Individuals aged 20-65 years
  • Seen for weight management in the Nutrition Clinic at the Mayo Clinic
  • Recruited prior to undergoing Roux-en-Y Gastric Bypass surgery
  • Have a fasting glucose concentration of ≥ 126 mg/dl on two or more occasions
  • Or  have a history of type 2 diabetes or impaired fasting glucose treated with one or two oral agents other than thiazolidinediones
  • Control group with type 2 diabetes or impaired fasting glucose who are not interested in pursuing surgical intervention but are willing to undergo supervised caloric restriction 
    • The 2 groups will be matched for age, gender, BMI and the duration and severity (HbA1c and number of oral medications needed to achieve glycemic control) of diabetes

 

Exclusion Criteria

  • Subjects < 20 years of age will not be studied to minimize the possibility of type 1 diabetes
  • Subjects > 65 years of age will not be studied to minimize the potential confounding effects of age on glucose tolerance
  • Subjects on chronic antibiotic therapy will be excluded due to their influence on gut bacteria
    • Subjects will refrain from using antibiotics for 2 weeks prior to the screening visit until completion of the study, except for routine peri-operative use and as clinically indicated
  • Healthy status will indicate that the participant has no known active systemic illness and no active microvascular or macrovascular complications of their diabetes

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Meera Shah, M.B., Ch.B.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20164526

Mayo Clinic Footer