Status:
WITHDRAWN
Blood Glucose Variability in Obese Youth Participating in a Lifestyle Modification Program
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
7-16 years
Brief 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 obe...
Detailed Description
Healthy lifestyle intervention programs aim to increase exercise and teach youth and about healthier dietary options, in hopes of avoiding obesity complications such as diabetes, and addressing the ro...
Eligibility Criteria
Inclusion
- 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
- 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 from follow-up monitoring
Key Trial Info
Start Date :
September 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02296034
Start Date
September 1 2015
End Date
March 1 2016
Last Update
March 9 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.