Overview

Surgical or Medical Treatment

Status:
Recruiting
Trial end date:
2024-08-30
Target enrollment:
0
Participant gender:
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 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborator:
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