Advanced Medical Therapy and Bariatric Surgery
ProcedureVertical Sleeve Gastrectomy and Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin for youth with type 2 diabetes
NCT Number: NCT04128995
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.
This study is active but is not currently recruiting participants.
13 year–19 year
All sexes
Interventional
Phase 4
Children's Hospital Colorado, Aurora, Colorado, United States
Youth-onset type 2 diabetes (T2D) leads to early dependence on exogenous insulin and progression of T2D co-morbidities, including dyslipidemia, hypertension, non-alcoholic fatty liver disease and diabetic kidney disease. The pathophysiology of T2D in youth differs considerably from adults and current treatment approaches are in-adequate for youth. Thus, exploration of innovative approaches to reduce co-morbidities is critical. Metabolic bariatric surgery (MBS) significantly improves multiple outcomes in adults with T2D. Initial small, uncontrolled studies of Roux-en-Y gastric bypass also suggest beneficial effects in youth with T2D, but definitive studies and understanding of mechanisms in youth-onset T2D are lacking, especially with the now more common form of MBS, vertical sleeve gastrectomy (VSG).
We will test the hypothesis that VSG will be more effective in reducing glycemia and comorbidities than the best currently available medical treatment: advanced medical therapy (AMT), via pancreatic, enterohepatic and/or metabolic changes. To test this hypothesis, 90 adolescents with T2D will be studied to compare the effects of VSG vs. AMT on glycemic control and T2D-associated comorbidities, as well as underlying mechanisms.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for the medical or surgical type 2 diabetes groups
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
Exclusion criteria
for the obese control group
Vertical Sleeve Gastrectomy and Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin for youth with type 2 diabetes
Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin for youth with type 2 diabetes
Vertical Sleeve Gastrectomy for youth without type 2 diabetes
Other names: Vertical Sleeve Gastrectomy
Time frame: At one year
Hemoglobin A1c of <6.5%
Time frame: At two years
Hemoglobin A1c <6.5% at 2 years
Time frame: At one year
Time In Range by Continuous Glucose Monitoring
Time frame: at 1 and 2 years
Oral disposition index= Insulin secretion [insulinogenic index] * insulin sensitivity [1/fasting insulin]
Time frame: at 1 and 2 years
Glucagon area under the curve from mixed meal tolerance testing
Time frame: at 1 and 2 years
GLP-1 area under the curve from mixed meal tolerance testing
Time frame: at 1 and 2 years
Hepatic Fat (<5% )by Magnetic Resonance imaging
Time frame: at 1 and 2 years
LDL <130mg/dL
Time frame: at 1 and 2 years
Blood pressure <130/80 mmHg
Time frame: At 1 and 2 years
Urinary albumin excretion <30μg/mg
Children's Hospital Medical Center, Cincinnati
Other
Surgical or Medical Treatment for Pediatric Type 2 Diabetes
Acronym: ST2OMP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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