Metabolic Abnormalities, Obese Adolescents, Obesity & Overweight
Conditions
Keywords
continuous glucose monitor, obesity, overweight, Metabolic abnormality
Brief summary
The objective of this project is to determine the feasibility of introducing CGMs to adolescent patients with obesity and pre-diabetes (Hemoglobin A1C: HbA1C between 5.7-6.5%) to determine whether their eating habits and subsequent glucose profiles are modified by the timely awareness of glucose excursions above the diabetes threshold of 200 mg/dl.
Detailed description
Building on prior UF protocols and national ORBIT-model guidance for early-phase behavioral-treatment development, this study represents a Phase I/IIa feasibility and signal-of-efficacy trial. The study is a comparison of food choice and decision making between a NO CGM group and a Open-label CGM group. Several bio markers are used to determine the consequences of nutritional choices. This information is used in nutritional counselling sessions.
Interventions
DEVICEUse of an unblinded CGM device
Open use of CGM device where patients can see their blood glucose values.
Sponsors
University of Florida
Healthcare Network
Collier County Health Services
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 13-17 years. * BMI ≥ 95 percentile * BMI \>85th and BMI \< 95th percentile for age and sex (CDC growth charts) if the risk factors below are present: Family history of type 2 diabetes in first or second degree relative: * Race/ethnicity Native American, African American, Latino, Asian American, Pacific Islander * Signs of insulin resistance or conditions associated with insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, polycystic ovary syndrome, or small-for-gestational-age birth weight) * Maternal history of diabetes or gestational diabetes mellitus (GDM) during the child's gestation * Receiving care through HCN for pediatric or family medicine clinics. * No structured nutritional intervention in the past 3 months. * Parent/guardian able to provide informed consent and child able to assent. * Family has access to a smartphone or is willing to use a study-provided device for CGM viewing and communication. * Willingness to comply with study visits, CGM wear, and laboratory testing.
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation: * Diabetes by history or HbA1c ≥ 6.5 % in the medical record or at screening. * Unable or unwilling to provide consent or participate fully in study activities. * Conditions predisposing to diabetes or altering normal pubertal development. * Current or planned use of medications affecting glucose dynamics, including: o Insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, metformin, or other glucose-lowering or weight-loss medications within 6 weeks prior to enrollment or planned during the study period. * Known syndromic or monogenic obesity. * Blood disorders that impact HbA1c interpretation (e.g., anemia, and hemoglobin variants). * Major systemic organ disease (renal, hepatic, or cardiac). * History or planned bariatric surgery. * Current pregnancy or plans for pregnancy during the study. * Use or planned use of GnRH agonists, estrogen, or testosterone. * Non-English- or non-Spanish-speaking individuals, as validated questionnaires are available only in these languages.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total caloric intake | Baseline; 3 Months | Total caloric intake as assessed from a validated 24-hour Dietary Recall |
| Total grams of carbohydrates from sugar | Baseline; 3 Months | Total grams of carbohydrates from sugar in food as assessed from a validated 24-hour Dietary Recall |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-point Likert scale Questionnaire of child food understanding | Baseline; 3 Months | Results from a questionnaire assessing the child's understanding of food on a 5-point likert scale |
| Metabolic outcome - Difference in Hba1c | Baseline; 3 Months | Difference in Hba1c, tested per standard of care |
| Metabolic outcome - Difference in BMI Z score | Baseline; 3 Months | Difference in BMI Z score, per standard of care |
| Metabolic outcome - Difference in complete metabolic panel | Baseline; 3 Months | Difference in complete metabolic panel between baseline and 3 months, per standard of care |
| Differences in Fitness assessment scores | Baseline; 3 Months | Difference in Fitness Assessment scores using an already published fitness assessment testing battery given to each patient |
Countries
United States
Contacts
CONTACTAngelina Bernier, MD
CONTACTSalvatore Anzalone, MD
Outcome results
None listed