A Low-Carb Approach to Treat Type 2 Diabetes in Pediatric Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: low carb diet, diabetic diet.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Carb Control: Low-Carbohydrate Dietary Intervention for Pediatric Patients With Type 2 Diabetes
Overview
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.
Interventions
- Behavioral low carb diet
diet based on low carb with max 50-80 grams of carbohydrates daily - Behavioral diabetic diet
Balanced diet based on standard of care recommendations for type 2 diabetes
Primary outcome measures
- 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]
Secondary outcome measures (4)
- Change in BMI [Time frame: Base line, 3 months, 6 months]
- Change in blood pressure [Time frame: Base line, 3 months, 6 months]
- Change in lipid profile [Time frame: Base line, 3 months, 6 months]
- Change in body composition [Time frame: Base line, 3 months, 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Alabama at Birmingham/ Children's of Alabama — Birmingham
Identifiers
NCT: NCT06902077 · IRB-300014030 · 3130035.000.213130035.31165200