ACTIVE_NOT_RECRUITING

Surgical or Medical Treatment

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Conditions

Diabetes Mellitus, Type 2Pediatric ObesityBariatric Surgery Candidate

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Surgical or Medical Treatment for Pediatric Type 2 Diabetes

Quick Facts

Study Start:2019-12-15
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04128995

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Amy S Shah, MD MS
PRINCIPAL_INVESTIGATOR
Cincinnati Childrens Hospital Medical Center
Kristen J Nadeau, MD MS
PRINCIPAL_INVESTIGATOR
Children's Hospital Colorado
Michael A Helmrath, MD MS
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Thomas H Inge, MD PhD
PRINCIPAL_INVESTIGATOR
Lurie Children's Hospital

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Lurie Children's Hospital
Chicago, Illinois, 60611
United States
Cincinnati Childrens
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Amy S Shah, MD MS, PRINCIPAL_INVESTIGATOR, Cincinnati Childrens Hospital Medical Center
  • Kristen J Nadeau, MD MS, PRINCIPAL_INVESTIGATOR, Children's Hospital Colorado
  • Michael A Helmrath, MD MS, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati
  • Thomas H Inge, MD PhD, PRINCIPAL_INVESTIGATOR, Lurie Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-15
Study Completion Date2026-12

Study Record Updates

Study Start Date2019-12-15
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

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