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Surgical or Medical Treatment (ST2OMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04128995
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : April 6, 2023
Sponsor:
Collaborator:
Children's Hospital Colorado
Information provided by (Responsible Party):
Amy Shah, Children's Hospital Medical Center, Cincinnati

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Pediatric Obesity Bariatric Surgery Candidate Procedure: Advanced Medical Therapy and Bariatric Surgery Drug: Advanced Medical Therapy Procedure: Bariatric Surgery Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical or Medical Treatment for Pediatric Type 2 Diabetes
Actual Study Start Date : December 15, 2019
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : September 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Medical Therapy and Bariatric Surgery in Youth with Type 2 Diabetes
Youth with type 2 diabetes undergoing bariatric surgery, n=45
 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
Active Comparator: Medical Therapy in Youth with Type 2 Diabetesin Youth with Type 2 Diabetes
Youth with type 2 diabetes receiving medical management, n=45
 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
Active Comparator: Bariatric Surgery in Youth with Obesity
Youth with no obesity undergoing bariatric surgery, n=10
 Procedure: Bariatric Surgery
Vertical Sleeve Gastrectomy for youth without type 2 diabetes
Other Name: Vertical Sleeve Gastrectomy


Outcome Measures
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Primary Outcome Measures :
  1. Glycemic Control [ Time Frame: At one year ]
    Hemoglobin A1c of <6.5%


Secondary Outcome Measures :
  1. Glycemic Control [ Time Frame: At two years ]
    Hemoglobin A1c <6.5% at 2 years

  2. Glycemic Variability [ Time Frame: At one year ]
    Time In Range by Continuous Glucose Monitoring

  3. Beta Cell Function [ Time Frame: at 1 and 2 years ]
    Oral disposition index= Insulin secretion [insulinogenic index] * insulin sensitivity [1/fasting insulin]

  4. Alpha cell function [ Time Frame: at 1 and 2 years ]
    Glucagon area under the curve from mixed meal tolerance testing

  5. Incretin Response [ Time Frame: at 1 and 2 years ]
    GLP-1 area under the curve from mixed meal tolerance testing

  6. Fatty Liver Disease [ Time Frame: at 1 and 2 years ]
    Hepatic Fat (<5% )by Magnetic Resonance imaging

  7. Dyslipidemia [ Time Frame: at 1 and 2 years ]
    LDL <130mg/dL

  8. Hypertension [ Time Frame: at 1 and 2 years ]
    Blood pressure <130/80 mmHg

  9. Diabetic Kidney Disease [ Time Frame: At 1 and 2 years ]
    Urinary albumin excretion <30μg/mg


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128995


Contacts
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Contact: Amy S Shah, MD 513-636-4744 amy.shah@cchmc.org
Contact: Kristen J Nadeau, MD (720) 777-6128 Kristen.Nadeau@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Amy Baumgartner    720-777-6143    amy.baumgartner@childrenscolorado.org   
Principal Investigator: Kristen J Nadeau, MD         
Sub-Investigator: Megan M Kelsey, MD         
Sub-Investigator: Sarkis Derderian, MD         
United States, Illinois
Lurie Children's Hospital Active, not recruiting
Chicago, Illinois, United States, 60611
United States, Ohio
Cincinnati Childrens Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Allen Riegler    513-636-4744    jenni.sizemore@cchmc.org   
Principal Investigator: Michael A Helmrath, MD         
Principal Investigator: Amy S Shah, MD         
Sub-Investigator: Stavra Xanthakos, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Children's Hospital Colorado
Investigators
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Principal Investigator: Amy S Shah, MD MS Cincinnati Childrens Hospital Medical Center
Principal Investigator: Kristen J Nadeau, MD MS Children's Hospital Colorado
Principal Investigator: Michael A Helmrath, MD MS Children's Hospital Medical Center, Cincinnati
Principal Investigator: Thomas H Inge, MD PhD Lurie Children's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amy Shah, Professor, Department of Pediatrics, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04128995    
Other Study ID Numbers: R01DK119450 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: April 6, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The PI's will also report a of summary results information (including adverse events) after completion of the study. All data from the study including any negative findings will be published in peer reviewed manuscripts.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Pediatric Obesity
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight