RECRUITING

CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance

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

The incidence of type 2 diabetes (T2D) in children is increasing, paralleling the rising incidence of obesity. Preventing children and adolescents from developing T2D is critical. The health benefits of lifestyle modifications are well documented in this population, but success rates are low. Obesity in children and adolescents increases the risk of not only T2D but other complications as well, such as hypertension, dyslipidemias and more. The investigators hypothesize that having real-time glucose data with the use of a continuous glucose monitor (CGM) in obese patients with impaired glucose tolerance will improve adherence to lifestyle modifications. As a result, a decrease in body mass index (BMI) is expected with subsequent improvement in insulin sensitivity, thus reducing risk of obesity-related complications later in childhood/adolescence and adulthood.

Official Title

Effect of Adding Continuous Glucose Monitoring (CGM) to Lifestyle Changes on Insulin Sensitivity in Patients With Impaired Glucose Tolerance

Quick Facts

Study Start:2022-12-01
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05387551

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:10 Years to 16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Children 10 to \<17 years old (i.e., before their 17th birthday)
  2. 2. Impaired glucose tolerance based on standardized oral glucose tolerance test (OGTT) or fasting glucose per American Diabetes Association criteria,
  3. 3. Overweight or obese (BMI ≥85th percentile for age/sex)
  4. 4. Patients are pubertal, defined as females with breast Tanner stage II or above, or males with testicular volume ≥4 mL
  1. 1. Existing diagnosis of type 1 or type 2 diabetes
  2. 2. Prepubertal
  3. 3. Taking medications that affect insulin sensitivity (e.g.,chronic corticosteroids whether systemic or inhaled). Metformin allowed if stable dose.
  4. 4. Patients and/or families not willing to wear the CGM for the duration of the study period or lack of compliance after recruitment

Contacts and Locations

Study Contact

Larry Fox, MD
CONTACT
9046973674
larry.fox@nemours.org
Liezel Riego
CONTACT
9046973431
Liezel.Riego@nemours.org

Principal Investigator

Larry A Fox, MD
PRINCIPAL_INVESTIGATOR
Nemours Children's Health

Study Locations (Sites)

Nemours Children's Clinic
Jacksonville, Florida, 32207
United States

Collaborators and Investigators

Sponsor: Nemours Children's Clinic

  • Larry A Fox, MD, PRINCIPAL_INVESTIGATOR, Nemours Children's Health

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 Date2022-12-01
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2022-12-01
Study Completion Date2025-03-31

Terms related to this study

Keywords Provided by Researchers

  • impaired glucose tolerance
  • obesity
  • adolescents

Additional Relevant MeSH Terms

  • Impaired Glucose Tolerance