Surgical or Medical Treatment

Diabetes Mellitus, Type 2 Clinical Trial

— ST2OMP  

Official title:

Surgical or Medical Treatment for Pediatric Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04128995
• Other study ID #: R01DK119450
• Status: Recruiting
• Phase: Phase 4
• Start date: December 15, 2019
• Est. completion date: December 1, 2025

Study information

• Verified date: August 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Amy S Shah, MD
• Phone: 513-636-4744
• Email: amy.shah[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Diabetes Mellitus, Type 2
• Pediatric Obesity

Intervention

Procedure:
• Advanced Medical Therapy and Bariatric Surgery
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

Drug:
• Advanced Medical Therapy
Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin for youth with type 2 diabetes

Procedure:
• Bariatric Surgery
Vertical Sleeve Gastrectomy for youth without type 2 diabetes

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Lurie Children's Hospital	Chicago	Illinois
United States	Cincinnati Childrens	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Control	Hemoglobin A1c of <6.5%	At one year
Secondary	Glycemic Control	Hemoglobin A1c <6.5% at 2 years	At two years
Secondary	Glycemic Variability	Time In Range by Continuous Glucose Monitoring	At one year
Secondary	Beta Cell Function	Oral disposition index= Insulin secretion [insulinogenic index] * insulin sensitivity [1/fasting insulin]	at 1 and 2 years
Secondary	Alpha cell function	Glucagon area under the curve from mixed meal tolerance testing	at 1 and 2 years
Secondary	Incretin Response	GLP-1 area under the curve from mixed meal tolerance testing	at 1 and 2 years
Secondary	Fatty Liver Disease	Hepatic Fat (<5% )by Magnetic Resonance imaging	at 1 and 2 years
Secondary	Dyslipidemia	LDL <130mg/dL	at 1 and 2 years
Secondary	Hypertension	Blood pressure <130/80 mmHg	at 1 and 2 years
Secondary	Diabetic Kidney Disease	Urinary albumin excretion <30µg/mg	At 1 and 2 years