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

NCT ID: NCT06902077

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-25
• Study Completion Date: 2027-12-31

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.

Detailed Description

Background Type 2 diabetes (T2D) in teenagers is becoming a growing health concern. In the U.S., the number of children and teens diagnosed with T2D nearly doubled between 2002 and 2018. Experts predict that in the next 40 years, the number of young people with T2D could quadruple.

T2D in youth is different from T2D in adults. Teens with T2D have more insulin resistance and their bodies struggle to make enough insulin. Unfortunately, common diabetes medications do not stop the disease from getting worse. Better treatment options for young people with T2D are needed.

T2D happens when the body becomes resistant to insulin and the pancreas struggles to keep up. Diet is a key part of managing T2D, but there are no clear guidelines for the best diet for teens with diabetes.

In adults, low-carbohydrate diets (LCDs) have been shown to:

• Lower blood sugar and improve diabetes control
• Improve insulin function and protect the pancreas
• Reduce the need for diabetes medications
• Help with weight loss, especially in areas of harmful fat like the liver and belly

While LCDs have been well-studied in adults, there is very little research on how they affect adolescents with T2D. A few small studies suggest that reducing carbs may help teens with obesity and fatty liver disease, but we need more evidence to know for sure.

Study Objective This study will test whether a low-carbohydrate diet (LCD) can help improve blood sugar control and insulin function in adolescents with T2D. The investigators will compare it to the standard diet for diabetes care.

How the Study Works

The investigators will conduct a randomized controlled trial (RCT), meaning that participants will be randomly placed into one of two groups:

• Low-Carb Diet (LCD): 50-80 grams of carbohydrates per day
• Standard Diabetes Diet (SCD): A diet based on current guidelines

The study will last 24 weeks (6 months). Participants will keep food records and meet with a dietitian to track their progress.

What The Study Will Measure

The investigators will test whether the low-carb diet helps improve:

• Blood sugar control (measured by HbA1c)
• Insulin function and resistance (measured by an oral glucose tolerance test)
• Weight and fat loss, especially in harmful fat stores
• Triglycerides and cholesterol levels
• Need for diabetes medications

What The Study Expect to Find

The investigators believe that teens who follow a low-carb diet will have:

• Better blood sugar control
• Less insulin resistance
• More weight loss, especially from harmful fat
• Lower triglycerides and better cholesterol levels
• Less need for diabetes medications

This study will help us understand whether reducing carbs is a safe and effective way to improve diabetes in teens.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

low carb diet

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

diabetic diet

Intervention Type: BEHAVIORAL

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

Interventions

low carb diet

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

Intervention Type: BEHAVIORAL

diabetic diet

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's of Alabama

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Ortal Resnick

Fellow- Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ortal Resnick, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham/ Children's of Alabama

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ortal Resnick, MD

Role: CONTACT

oresnick@uabmc.edu

205-638-9107

Facility Contacts

Ortal Resnick, MD

Role: primary

oresnick@uabmc.edu

205-638-9107

Other Identifiers

3130035.000.213130035.31165200

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300014030

Identifier Type: -

Identifier Source: org_study_id