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Recruiting NCT06902077
A Low-Carb Approach to Treat Type 2 Diabetes in Pediatric Patients
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Plain-language summary for patients
Trial Parameters
Condition Type 2 Diabetes
Sponsor University of Alabama at Birmingham
Study Type INTERVENTIONAL
Phase N/A
Enrollment 40
Sex ALL
Min Age 12 Years
Max Age 18 Years
Start Date 2025-11-25
Completion 2027-08-31
Interventions
low carb dietdiabetic diet
Eligibility Fast-Check
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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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Current insulin treatment * Renal impairment measured as creatinine \> 1 mg/dL * Hepatic dysfunction measured as AST and ALT \>100 IU/ml
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