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

Early Phase 1

Not yet recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT06902077
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Study Start: 2025-07-01
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	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)	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

Secondary Outcome Measures

Name	Time	Method
Change in lipid profile	Base line, 3 months, 6 months	Fasting lipid profile will be assessed via venous blood sample. Parameters will include total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides.; Unit of Measure: Milligrams per deciliter (mg/dL)
Change in body composition	Base line, 3 months, 6 months	Body composition will be assessed using a validated bioelectrical impedance analysis (BIA) scale, which estimates fat mass, lean mass, and total body water.; Measurement Tool: Bioelectrical impedance analysis (BIA) scale; Unit of Measure: Percent body fat (%) and lean mass (%)
Change in BMI	Base line, 3 months, 6 months	Weight and height will be combined to report BMI. Weight in kilograms divided by height in meters squared (kg/m²). Height will be measured using a wall-mounted stadiometer.; Unit of Measure: kg/m²
Change in blood pressure	Base line, 3 months, 6 months	Systolic and diastolic blood pressure will be measured in triplicate using an automated oscillometric blood pressure monitor after the participant has been seated quietly for 5 minutes.; Measurement Tool: Automated oscillometric blood pressure monitor; Unit of Measure: Millimeters of mercury (mmHg)

Trial Locations

Locations (1)

University of Alabama at Birmingham/ Children's of Alabama; 🇺🇸 Birmingham, Alabama, United States