Impaired Glucose Tolerance Clinical Trial
Official title:
Effect of Adding Continuous Glucose Monitoring (CGM) to Lifestyle Changes on Insulin Sensitivity in Patients With Impaired Glucose Tolerance
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | March 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 16 Years |
Eligibility | Inclusion Criteria: 1. Children 10 to <17 years old (i.e., before their 17th birthday) 2. Impaired glucose tolerance based on standardized oral glucose tolerance test (OGTT) or fasting glucose per American Diabetes Association criteria, 3. Overweight or obese (BMI =85th percentile for age/sex) 4. Patients are pubertal, defined as females with breast Tanner stage II or above, or males with testicular volume =4 mL Exclusion Criteria: 1. Existing diagnosis of type 1 or type 2 diabetes 2. Prepubertal 3. Taking medications that affect insulin sensitivity (e.g.,chronic corticosteroids whether systemic or inhaled). Metformin allowed if stable dose. 4. Patients and/or families not willing to wear the CGM for the duration of the study period or lack of compliance after recruitment |
Country | Name | City | State |
---|---|---|---|
United States | Nemours Children's Clinic | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Nemours Children's Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Insulin Sensitivity Score (ISS) | Change in insulin sensitivity as measured by insulin sensitivity Score (ISS). The ISS directly correlates with insulin sensitivity. Higher scores indicate higher insulin sensitivity; lower scores indicate more insulin resistance. | Baseline to 6 months | |
Secondary | QUICKI insulin sensitivity | Change in insulin sensitivity as measured by QUICKI | Baseline to 3 months | |
Secondary | QUICKI insulin sensitivity | Change in insulin sensitivity as measured by QUICKI | Baseline to 6 months | |
Secondary | Insulin Sensitivity Score | Change in insulin sensitivity as measured by insulin sensitivity Score (ISS). The ISS directly correlates with insulin sensitivity. Higher scores indicate higher insulin sensitivity; lower scores indicate more insulin resistance. | Baseline to 3 months | |
Secondary | Glycemic levels | Change in characteristics of glycemic levels obtained from the CGM data. This will include:
mean, standard deviation of glucose levels time in range (glucose between 70-140 mg/dL) percent of time with hyperglycemia (>140 mg/dL) percent of time with hypoglycemia (<70 mg/dL) |
Baseline to 3 and 6 months | |
Secondary | Mean, standard deviation of sensor glucose levels | Change in characteristics of glycemic levels obtained from the CGM data, including mean and standard deviation of sensor glucose levels (mg/dL). | Baseline to 3 and 6 months | |
Secondary | Time in range of sensor glucose levels | Change in glycemic levels obtained from the CGM data: Percent of time in range (glucose between 70-140 mg/dL) | Baseline to 3 and 6 months | |
Secondary | Percent of sensor glucose levels in hypoglycemic range | Change in glycemic levels obtained from the CGM data: Percent of time with hypoglycemia (<70 mg/dL) | Baseline to 3 and 6 months | |
Secondary | Percent of sensor glucose levels in hyperglycemic range | Change in glycemic levels obtained from the CGM data: Percent of time with hyperglycemia (>140 mg/dL) | Baseline to 3 and 6 months | |
Secondary | Physical activity questionnaires | Questionnaires will be used to assess amount of time participants are active. Two questions regarding physical activity will be asked, with a scale set up as follows:
How many minutes of continuous physical activity per week were completed? Possible answers will be <10, 11-20, 21-30, 31-60, 61-90, 91-120, or 121-150. How many days per week of physical activity longer than 30 minutes? Possible answers will be 0, 1, 2, 3, 4, 5, 6, or 7. |
3 and 6 months | |
Secondary | Dietary compliance questionnaires | Questionnaires will be used to assess particpants' compliance witih dietary changes. Four questions regarding their diet will be asked, with a scale set up as follows:
How many sugary drinks per week? Possible answers will be 0, 1-2, 3-5, or >5. How many unhealthy snacks per week? Possible answers will be 0, 1-2, 3-5, or >5. How many times junk food was consume in the past week? Possible answers will be 0, 1-2, 3-5, or >5. How often were the proper portion sizes followed (as per control plate)? Possible answers will be always, most days, occasionally, or never. |
3 and 6 months |
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