A Low-Carb Approach to Treat Type 2 Diabetes in Pediatric Patients
Recruiting · NCT06902077 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alabama at Birmingham
View the official record on ClinicalTrials.gov →Interventions studied
diabetic dietlow carb diet
What this trial is about
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.
Who can take part
Age range
12 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- University of Alabama at Birmingham/ Children's of Alabama - Birmingham, Alabama, United States