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Low-Carb Diet for Type 2 Diabetes in Teenagers

This study is looking at how a low-carbohydrate diet compares to a standard diabetes diet for teenagers with Type 2 Diabetes. Researchers want to see if a low-carb diet, which limits carbohydrates to 50-80 grams daily, can help improve blood sugar control and insulin function better than a balanced diet. You might be able to join if you are 12-18 years old, have had Type 2 Diabetes for at least three months, and your HbA1c (a measure of blood sugar over time) is between 6.5% and 8.5%. The study will measure changes in your HbA1c and how well your body uses insulin over six months. The current status of this study is unclear, and it plans to enroll 40 participants.

Study design
This is an interventional study comparing two different diets in 40 participants aged 12-18 with Type 2 Diabetes.
What's involved
Participants will follow a specific diet for 24 weeks. Blood tests for HbA1c, HOMA-IR, and WBISI will be taken at the beginning, at 3 months, and at 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for six months, with measurements taken at baseline, 3 months, and 6 months.

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NCT06902077

A Low-Carb Approach to Treat Type 2 Diabetes in Pediatric Patients

Recruiting
NAAges 12–18InterventionalTreatment
University of Alabama at Birmingham
~40 participants
Updated 2025-12-08 on ClinicalTrials.gov
What's tested:low carb dietdiabetic diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in HbA1c
Measured over Base line, 3 months, 6 months
+2 more outcomes measured

Conditions

Type 2 Diabetes

Explore related trials

Type 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Alabama1

Study leadership

  • Ortal Resnick, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Ortal Resnick, MD
[email protected]
205-638-9107
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Current insulin treatment
Renal impairment measured as creatinine \> 1 mg/dL
Hepatic dysfunction measured as AST and ALT \>100 IU/ml

What this trial measures

  • Change in HbA1cBase 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)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)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