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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 : January 2, 2020
Sponsor:
Collaborator:
Children's Hospital Colorado
Information provided by (Responsible Party):
Amy Shah, Children's Hospital Medical Center, Cincinnati

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: Bariatric Surgery Drug: Advanced Medical Therapy 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label prospective clinical trial
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 : January 5, 2022
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bariatric Surgery Procedure: Bariatric Surgery
Vertical Sleeve Gastrectomy and Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin

Active Comparator: Medical Therapy Drug: Advanced Medical Therapy
Use of combination medical therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin




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



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:

  • Age 13-19.9 years of age at time of consent
  • Type 2 diabetes by the American Diabetes Association criteria
  • Negative diabetes-associated antibodies
  • BMI greater than or equal to 35
  • Willingness to take oral medications and/or diabetes subcutaneous medications as medically indicated

Exclusion Criteria:

  • Known type 1 diabetes of maturity onset diabetes on the young (MODY) or secondary diabetes
  • Chronic kidney or liver disease (except NAFLD or DKD)
  • Pregnancy or breast-feeding
  • Genetic cause of obesity or hypothalamic obesity
  • Prior bariatric surgery
  • History of malignancy
  • Current participating in another clinical trial affecting study outcomes

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: Susan Gross, MS RD    720-777-6143    susan.gross@childrenscolorado.org   
Principal Investigator: Kristen J Nadeau, MD         
Principal Investigator: Thomas H Inge, MD         
Sub-Investigator: Megan M Kelsey, MD         
United States, Ohio
Cincinnati Childrens Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Kelsey S Frenck    513-636-4744    kelsey.frenck@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 Children's Hospital Colorado
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Responsible Party: Amy Shah, Associate Professor, 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: January 2, 2020
Last Verified: December 2019
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
Overnutrition
Nutrition Disorders
Overweight
Body Weight