Low-carb diet to treat Type 2 diabetes in teens.
Carb Control: Low-Carbohydrate Dietary Intervention for Pediatric Patients With Type 2 Diabetes
This 24-week test will see if a low-carb diet helps control blood sugar and improve insulin function in teens (ages 12–18) with Type 2 diabetes who are not using insulin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06902077 on ClinicalTrials.gov |
What this trial studies
Adolescents with Type 2 diabetes will follow either a low-carbohydrate diet or a standard-carbohydrate diabetic diet for 24 weeks while researchers monitor blood sugar control and markers of insulin function. Participants must have had diabetes for more than three months, HbA1c between 6.5–8.5%, BMI above the 85th percentile, negative pancreatic autoantibodies, and be on a stable dose of permitted diabetic medications; current insulin users and those with significant kidney or liver dysfunction are excluded. The study compares changes in HbA1c, measures of insulin sensitivity, medication needs, and body composition between the two diet groups. Regular clinical visits and laboratory testing will track safety and metabolic outcomes over the trial period.
Who should consider this trial
Good fit: Teens aged 12–18 with Type 2 diabetes for more than three months, HbA1c 6.5–8.5%, BMI above the 85th percentile, negative pancreatic autoantibodies, and on a stable dose of non-insulin diabetic medications are ideal candidates.
Not a fit: Patients who are using insulin, have significant renal or liver impairment, or have diabetes outside the specified HbA1c range are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, a low-carb diet could improve blood sugar control and insulin function, potentially reducing medication needs and excess weight in teens with T2D.
How similar studies have performed: Low-carbohydrate diets have shown benefits for glycemic control and weight in adults, but pediatric data are limited to a few small studies and remain preliminary.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham/ Children's of Alabama — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Ortal Resnick, MD — University of Alabama at Birmingham
- Study coordinator: Ortal Resnick, MD
- Email: oresnick@uabmc.edu
- Phone: 205-638-9107
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.