Recruiting

Low Carb Diet

Sponsor:

University of Alabama at Birmingham

Code:

NCT06902077

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

low carb diet

diabetic diet

Study Details

Brief summary:

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.

Conditions

Type 2 Diabetes

Study ID

NCT06902077

Start date

Nov 25, 2025

Status verified date

Dec, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

low carb diet

diet based on low carb with max 50-80 grams of carbohydrates daily

diabetic diet

Balanced diet based on standard of care recommendations for type 2 diabetes

Primary outcome measure

  • Change in HbA1c [ Time Frame: Base line, 3 months, 6 months ]
  • Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: Base line, 3 months, 6 months ]
  • Whole Body Insulin Sensitivity Index (WBISI) [ Time Frame: Base line, 3 months, 6 months ]

Central Contacts and Locations

Central contacts

Ortal Resnick, MD

205-638-9107oresnick@uabmc.edu

Locations

University of Alabama at Birmingham/ Children's of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Ortal Resnick, MD

205-638-9107oresnick@uabmc.edu

Principal Investigator:

Ortal Resnick, MD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Dec 8, 2025

Last verified

Dec, 2025

Keywords

  • Pediatric type 2 diabetes
  • Type 2 Diabetes
  • low carb diet
  • Low-Carbohydrate Dietary

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-12-08.