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| ID | Type | Description | Link |
|---|---|---|---|
| 3130035.000.213130035.31165200 | Other Grant/Funding Number | Fellows Research account |
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| Name | Class |
|---|---|
| Children's of Alabama | OTHER |
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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.
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:
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:
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:
What The Study Expect to Find
The investigators believe that teens who follow a low-carb diet will have:
This study will help us understand whether reducing carbs is a safe and effective way to improve diabetes in teens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low carb diet | Active Comparator | 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. |
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| Standard of care | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low carb diet | Behavioral | diet based on low carb with max 50-80 grams of carbohydrates daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | HbA1c levels will be measured to assess long-term glycemic control. Unit of Measure: Percent (%). | Base line, 3 months, 6 months |
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 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 | Base line, 3 months, 6 months |
| Whole Body Insulin Sensitivity Index (WBISI) | 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 | Base line, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI | 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 | Base line, 3 months, 6 months |
| Change in blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ortal Resnick, MD | Contact | 205-638-9107 | oresnick@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ortal Resnick, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham/ Children's of Alabama | Recruiting | Birmingham | Alabama | 35233 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D003927 | Diet, Diabetic |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| diabetic diet | Behavioral | Balanced diet based on standard of care recommendations for type 2 diabetes |
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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) |
| Base line, 3 months, 6 months |
| Change in lipid profile | 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) | Base line, 3 months, 6 months |
| Change in body composition | 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 (%) | Base line, 3 months, 6 months |
| D004700 | Endocrine System Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |