Overview
Surgical or Medical Treatment
Status:
Recruiting
Recruiting
Trial end date:
2024-08-30
2024-08-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study will test the hypothesis that metabolic bariatric surgery will be more effective at providing durable glycemic control and reduce co-morbidities than intensive medical therapy in youth with type 2 diabetes.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Children's Hospital Medical Center, CincinnatiCollaborator:
Children's Hospital Colorado
Criteria
Inclusion Criteria:- Age 13-19.9 years of age at time of consent
- Type 2 diabetes by the American Diabetes Association criteria
- Negative diabetes-associated antibodies
- BMI greater than or equal to 35
- Willingness to take oral medications and/or diabetes subcutaneous medications as
medically indicated
Exclusion Criteria:
- Known type 1 diabetes of maturity onset diabetes on the young (MODY) or secondary
diabetes
- Chronic kidney or liver disease (except NAFLD or DKD)
- Pregnancy or breast-feeding
- Genetic cause of obesity or hypothalamic obesity
- Prior bariatric surgery
- History of malignancy
- Current participating in another clinical trial affecting study outcomes