NCT06902077 · University of Alabama at Birmingham
A Low-Carb Approach to Treat Type 2 Diabetes in Pediatric Patients
What this study is about
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.
View original scientific description
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.
Interventions
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
Primary outcome measures
Change in HbA1c
Time frame: Base line, 3 months, 6 months
HbA1c levels will be measured to assess long-term glycemic control. Unit of Measure: Percent (%).
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Base line, 3 months, 6 months
HOMA-IR will be calculated using fasting glucose and insulin values collected at baseline. The formula used is: HOMA-IR = (fasting insulin \[μU/mL\] × fasting glucose \[mg/dL\]) / 405. This index reflects hepatic insulin resistance. Units of Measure: Unitless index
Whole Body Insulin Sensitivity Index (WBISI)
Time frame: Base line, 3 months, 6 months
WBISI will be calculated using values from the 2-hour Oral Glucose Tolerance Test (OGTT). The formula is: WBISI = 10,000 / √(fasting glucose × fasting insulin × mean OGTT glucose × mean OGTT insulin). This index reflects peripheral insulin sensitivity. Units of Measure: Unitless index
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Birmingham, Alabama
Collaborators
Children's of Alabama
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 8, 2025 · Source of record for eligibility and locations