Clinical trial NCT04128995: Surgical or Medical Treatment
Official title: Surgical or Medical Treatment for Pediatric Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Pediatric Obesity
Bariatric Surgery Candidate
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
First posted: 2019-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label prospective clinical trial. Primary comparison is medical (n=45) vs surgical (n=45) groups. Patients with obesity and no diabetes (n=10) are a comparator group.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Glycemic Control
timeFrame: At one year
Secondary outcomes:
measure: Glycemic Control
timeFrame: At two years
measure: Glycemic Variability
timeFrame: At one year
measure: Beta Cell Function
timeFrame: at 1 and 2 years
measure: Alpha cell function
timeFrame: at 1 and 2 years
measure: Incretin Response
timeFrame: at 1 and 2 years
measure: Fatty Liver Disease
timeFrame: at 1 and 2 years
measure: Dyslipidemia
timeFrame: at 1 and 2 years
measure: Hypertension
timeFrame: at 1 and 2 years
measure: Diabetic Kidney Disease
timeFrame: At 1 and 2 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
city: Cincinnati
country: United States
facility: Cincinnati Childrens
state: Ohio
Study officials:
affiliation: Cincinnati Childrens Hospital Medical Center
name: Amy S Shah, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Colorado
name: Kristen J Nadeau, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Michael A Helmrath, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Lurie Children's Hospital
name: Thomas H Inge, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah AS, Helmrath MA, Inge TH, Xanthakos SA, Kelsey MM, Jenkins T, Trout AT, Browne L, Nadeau KJ. Study protocol: a prospective controlled clinical trial to assess surgical or medical treatment for paediatric type 2 diabetes (ST2OMP). BMJ Open. 2021 Aug 13;11(8):e047766. doi: 10.1136/bmjopen-2020-047766.