RECRUITINGINTERVENTIONAL
A Low-Carb Approach to Treat Type 2 Diabetes in Pediatric Patients
Carb Control: Low-Carbohydrate Dietary Intervention for Pediatric Patients With Type 2 Diabetes
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- Current insulin treatment
- Renal impairment measured as creatinine \> 1 mg/dL
- Hepatic dysfunction measured as AST and ALT \>100 IU/ml
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
BEHAVIORAL
low carb diet
diet based on low carb with max 50-80 grams of carbohydrates daily
BEHAVIORAL
diabetic diet
Balanced diet based on standard of care recommendations for type 2 diabetes
Locations (1)
University of Alabama at Birmingham/ Children's of Alabama
Birmingham, Alabama, United States