A Low-Carb Approach to Treat Type 2 Diabetes in Pediatric Patients
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- University of Alabama at Birmingham
- Study ID
- NCT06902077
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- low carb diet — BEHAVIORALdiet based on low carb with max 50-80 grams of carbohydrates daily
- diabetic diet — BEHAVIORALBalanced diet based on standard of care recommendations for type 2 diabetes
Study Details
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.
Key Dates
- Start date
- Nov 25, 2025
- Status verified
- Dec 2025
- Primary completion
- Aug 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Low carb dietParticipants in this group will limit the amount of carbohydrates they eat each day to 50-80 grams. This means eating fewer sugars and starches (like bread, pasta, rice, and sweets). Instead, meals will focus on protein, healthy fats, and non-starchy vegetables. Participants will track their food and meet with a dietitian to help them stick to the plan.
- Active Comparator: Standard of careParticipants in this group will follow the current standard diet for managing diabetes. This includes balanced meals with carbohydrates, protein, and fats, based on regular diabetes guidelines. Participants will track their food and meet with a dietitian to help them stay on track.
Primary Outcome Measure
Change in HbA1c [ Time Frame: Base line, 3 months, 6 months ]
Central Contacts
- Ortal Resnick, MD205-638-9107
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham/ Children's of Alabama | Birmingham | Alabama | 35233 | Ortal Resnick, MD (PRINCIPAL_INVESTIGATOR) Ambika Ashraf, MD (SUB_INVESTIGATOR) |
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