Blood Glucose Variability in Obese Youth Participating in a Lifestyle Modification Program (NCT02296034) | Clinical Trial Compass
WithdrawnNot Applicable
Blood Glucose Variability in Obese Youth Participating in a Lifestyle Modification Program
Stopped: Unable to recruit participants
0Started 2015-09
Plain-language summary
The purpose of this study is to measure blood glucose variation in youth prior to and after participation in a healthy lifestyle intervention program. The hypothesis is that youth with more severe obesity and those further along in puberty will have more glycemic variability, and that glycemic variability will be improved by participation in the lifestyle intervention program.
Who can participate
Age range7 Years – 16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Obese (BMI \>95 percentile for age based on CDC growth charts)
* Willing to wear a CGM initially before and after the Bright Bodies program
* Willing to check fingersticks 3 times a day while wearing the CGM
* Willing to keep a food record before and after the Bright Bodies program
* Be in good general health without other acute or chronic illness that in the judgment of the investigator could interfere with the study or jeopardize subject safety
* Able to give consent (permission from parents and subject assent will be required)
* Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods
Exclusion Criteria:
* Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
* Prior participation in the Bright Bodies program.
* Diagnosis of diabetes
* Participation in a concurrent lifestyle modification (exercise/nutrition) program
* Use of any medications known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy
* Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
* Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
* Subjects and/or parents who are not proficient in speaking/understanding the English language
* Subjects who discontinue participation in the Bright Bodies program during the study period will be excluded…