Surgical or Medical Treatment (NCT04128995) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Surgical or Medical Treatment
United States88 participantsStarted 2019-12-15
Plain-language 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.
Who can participate
Age range13 Years – 19 Years
SexALL
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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 interfer…
What they're measuring
1
Glycemic Control
Timeframe: At one year
Trial details
NCT IDNCT04128995
SponsorChildren's Hospital Medical Center, Cincinnati