A Study of the Metabolome and Microbiome Following Bariatric Surgery, and the Effect on Metabolism in Patients with Type 2 Diabetes
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-000179
NCT ID: NCT02762708
Sponsor Protocol Number: 15-000179
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