Carb Control: Low-Carbohydrate Dietary Intervention for Pediatric Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Current insulin treatment
- •Renal impairment measured as creatinine > 1 mg/dL
- •Hepatic dysfunction measured as AST and ALT >100 IU/ml
研究组 & 干预措施
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.
干预措施: low carb diet (Behavioral)
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.
干预措施: diabetic diet (Behavioral)
结局指标
主要结局
Change in HbA1c
时间窗: 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)
时间窗: 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)
时间窗: 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
次要结局
- Change in lipid profile(Base line, 3 months, 6 months)
- Change in body composition(Base line, 3 months, 6 months)
- Change in BMI(Base line, 3 months, 6 months)
- Change in blood pressure(Base line, 3 months, 6 months)
研究者
Ortal Resnick
Fellow- Principal Investigator
University of Alabama at Birmingham