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 — BEHAVIORAL
    diet based on low carb with max 50-80 grams of carbohydrates daily
  • diabetic diet — BEHAVIORAL
    Balanced 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 diet
    Participants 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 care
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham/ Children's of AlabamaBirminghamAlabama35233
Ortal Resnick, MD
205-638-9107
Ortal Resnick, MD (PRINCIPAL_INVESTIGATOR)
Ambika Ashraf, MD (SUB_INVESTIGATOR)

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