Surgical or Medical Treatment

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Oct 14, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether metabolic bariatric surgery is more effective than intensive medical therapy for managing type 2 diabetes in young people. The goal is to see if surgery can help these patients maintain better blood sugar control and reduce related health issues over time. The trial is open to teenagers aged 13 to 19 who have been diagnosed with type 2 diabetes and meet specific criteria.

Participants in the trial can expect to be assigned to either the surgery or medical treatment group, and will be monitored for their health outcomes. To be eligible, they should not have type 1 diabetes, certain other health conditions, or have had previous bariatric surgery. It's important for interested individuals to understand that they will be part of a research study, which means that their progress will be closely observed, and they will be helping to learn more about treating diabetes in young people.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria for the medical or surgical type 2 diabetes groups
• • Age 13-19.9 years of age at time of signing the consent
• • Type 2 diabetes by the American Diabetes Association criteria
• • Negative diabetes-associated antibodies
• • Exclusion Criteria for the medical or surgical type 2 diabetes groups Known type 1 diabetes, maturity onset diabetes of the young (MODY), or secondary diabetes
• • Any chronic oral steroids use within 60 days of enrollment
• • Current pancreatotoxic drugs
• • Chronic kidney or liver disease (except NAFLD or DKD)
• • Pregnancy, breast-feeding or intension of becoming pregnant
• • Prior bariatric surgery
• • History of malignancy
• • Current participation in another clinical trial that may affect study outcomes
• • Other conditions, that in the determination of the study investigator, may interfere with study participation
• • Inclusion Criteria for the Obese control group
• • Age 13-19.9 years of age at time of signing the consent
• • Clinical indication to receive bariatric surgery
• • Exclusion Criteria for the obese control group
• • Known diabetes
• • Any chronic oral steroids use within 60 days of enrollment
• • Current pancreatotoxic drugs
• • Chronic kidney or liver disease (except NAFLD or DKD)
• • Pregnancy, breast-feeding or intension of becoming pregnant
• • Prior bariatric surgery
• • History of malignancy
• • Current participation in another clinical trial that may affect study outcomes
• • Other conditions, that in the determination of the study investigator, may interfere with study participation