Actively Recruiting
Carb Control: Low-Carbohydrate Dietary Intervention for Pediatric Patients With Type 2 Diabetes
Led by University of Alabama at Birmingham · Updated on 2025-12-08
40
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
C
Children's of Alabama
Collaborating Sponsor
AI-Summary
What this Trial Is About
Type 2 diabetes (T2D) in teenagers is an increasing health concern with rising diagnoses and unique challenges compared to adults. This research aims to study the effects of a low-carbohydrate diet (LCD) compared to a standard diabetes diet in adolescents with T2D over a 24-week period. The goal is to see if reducing carbohydrates can improve blood sugar control, insulin function, weight, and cholesterol in young patients. Participants will be randomly assigned to follow either a low-carb diet with 50-80 grams of carbohydrates daily or the current standard diabetes diet based on usual guidelines. Both groups will track their food intake and meet regularly with a dietitian to support adherence. The study lasts for 24 weeks, allowing careful comparison between the two dietary approaches. During the study, participants will undergo tests at baseline, 3 months, and 6 months to measure blood sugar control (HbA1c), insulin resistance, insulin sensitivity, body mass index, blood pressure, lipid profiles, and body composition. These assessments will help evaluate the diet's impact on diabetes management. The research is conducted by the University of Alabama at Birmingham and includes close monitoring of health and medication use throughout the study.
CONDITIONS
Brief Title
A Low-Carb Approach to Treat Type 2 Diabetes in Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 18 years
- Diagnosed with type 2 diabetes for more than 3 months
- HbA1c between 6.5% and 8.5%
- Body mass index (BMI) above the 85th percentile
- Negative pancreatic autoantibodies
- Stable dose of anti-diabetic drugs (GLP-1, metformin, SGLT-2 inhibitors) for 3 months or more
You will not qualify if you...
- Currently receiving insulin treatment
- Kidney problems with creatinine levels above 1 mg/dL
- Liver dysfunction with AST or ALT levels above 100 IU/ml
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks (6 months)
Participants follow either a low-carbohydrate diet or a standard diabetes diet while tracking their food intake and meeting regularly with a dietitian to support their progress.
Regular visits with a dietitian during the 24 weeks
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham/ Children's of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
Research Team
O
Ortal Resnick, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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