Clinical trial NCT06902077: A Low-Carb Approach to Treat Type 2 Diabetes in Pediatric Patients
Official title: Carb Control: Low-Carbohydrate Dietary Intervention for Pediatric Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Type 2 Diabetes
Keywords: Pediatric type 2 diabetes
Type 2 Diabetes
low carb diet
Low-Carbohydrate Dietary
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Children's of Alabama
First posted: 2025-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in HbA1c
timeFrame: Base line, 3 months, 6 months
measure: Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Base line, 3 months, 6 months
measure: Whole Body Insulin Sensitivity Index (WBISI)
timeFrame: Base line, 3 months, 6 months
Secondary outcomes:
measure: Change in BMI
timeFrame: Base line, 3 months, 6 months
measure: Change in blood pressure
timeFrame: Base line, 3 months, 6 months
measure: Change in lipid profile
timeFrame: Base line, 3 months, 6 months
measure: Change in body composition
timeFrame: Base line, 3 months, 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham/ Children's of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ortal Resnick, MD
role: PRINCIPAL_INVESTIGATOR
References: