Status:
COMPLETED
Effect of NNS on Metformin/GDF15, Pilot
Lead Sponsor:
University of Florida
Conditions:
Obesity, Adolescent
Pre Diabetes
Eligibility:
All Genders
10-21 years
Phase:
NA
Brief Summary
Metformin use for diabetes has the benefit of causing weight loss in some. The investigators in a preclinical trial, demonstrated that mice consuming non-nutritive sweetened (NNS) drinks had worse glu...
Detailed Description
This study will enroll 40 children ages 10-21 years (will be recruited from the University of Florida (UF) Pediatric Obesity\& Metabolic clinic in Gainesville) and randomize eligible participants into...
Eligibility Criteria
Inclusion
- Eligible patients will have already been prescribed Metformin as part of their normal clinical care
- Must also be aged 10-21 years
- Have a diagnosis of obesity (BMI \> 95th%ile or \>30 kg/m2 - whichever is lower) and pre-diabetes (A1c between 5.7 and 6.4%)
Exclusion
- Previous treatment with oral hypoglycemic medications, (2) resting systolic blood pressure (SBP)\>180 mm/Hg or diastolic blood pressure (DBP)\>100mm/Hg, (3) self-reported pregnancy
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT05400863
Start Date
April 21 2022
End Date
August 2 2024
Last Update
August 5 2024
Active Locations (1)
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1
UF pediatric metabolic and obesity clinic
Gainesville, Florida, United States, 32608