Status:
RECRUITING
A Low-Carb Approach to Treat Type 2 Diabetes in Pediatric Patients
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Children's of Alabama
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
The purpose of this project is to test the effect of a low carb diet compared to standard carb diet among adolescents with T2D over a 24-week period.
Detailed Description
Background Type 2 diabetes (T2D) in teenagers is becoming a growing health concern. In the U.S., the number of children and teens diagnosed with T2D nearly doubled between 2002 and 2018. Experts predi...
Eligibility Criteria
Inclusion
- Age 12-18
- Diabetes diagnosis \>3 months to ensure stable baseline glycemic control
- HbA1C between 6.5- 8.5%
- BMI \>85th percentile
- Negative pancreatic autoantibodies
- Stable dose of anti-diabetic drugs GLP-1, metformin, SGLT-2 inhibitors, for 3 months
Exclusion
- Current insulin treatment
- Renal impairment measured as creatinine \> 1 mg/dL
- Hepatic dysfunction measured as AST and ALT \>100 IU/ml
Key Trial Info
Start Date :
November 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06902077
Start Date
November 25 2025
End Date
December 31 2027
Last Update
December 8 2025
Active Locations (1)
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1
University of Alabama at Birmingham/ Children's of Alabama
Birmingham, Alabama, United States, 35233