NCT02888691已完成不适用
Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes: A Randomized Crossover Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Percentage of Time Spent in Euglycemia
研究概览
简要总结
The aim of the study is to investigate glycemic control during a low carbohydrate diet compared with during a high carbohydrate diet in adults with insulin pump treated type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes ≥3 years
- •Insulin pump use ≥1 year
- •HbA1c ≥53 mmol/mol (7.0%)
- •BMI 20-27 kg/m2
- •Willingness to count carbohydrates and use the insulin pump bolus calculator for all boluses during the intervention periods
- •Willingness to use continuous glucose monitoring consistently during the intervention periods
排除标准
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- •Use of SGLT-2-inhibitors
- •Use of corticosteroids during or within 30 days prior to the intervention periods
- •Celiac disease
- •Inflammatory bowel disease
- •Macroalbuminuria
- •Active proliferative retinopathy combined with an HbA1c ≥ 75 mmol/mol (9.0%)
- •Known or suspected alcohol or drug abuse
- •Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
结局指标
主要结局
Percentage of Time Spent in Euglycemia
时间窗: 12 weeks - from baseline to end of study
Time spent with glucose values 4.0-10.0 mmol/l assessed by continuous glucose monitoring
次要结局
- Magnesium(12 weeks - from baseline to end of study)
- IL-6(12 weeks - from baseline to end of study)
- Coefficient of Variation of Glucose(12 weeks - from baseline to end of study)
- Change in A1c(From baseline to 12 weeks)
- Total Daily Dose(12 weeks - from baseline to end of study)
- Supar(12 weeks - from baseline to end of study)
- Mean Amplitude of Glycemic Excursions(12 weeks - from baseline to end of study)
- AUC Low(12 weeks - from baseline to end of study)
- Weight(12 weeks - from baseline to end of study)
- Time Spent in Hyperglycemia(12 weeks - from baseline to end of study)
- AUC High(12 weeks - from baseline to end of study)
- Post Breakfast Glucose Excursion(12 weeks - from baseline to end of study)
- Total Daily Basal Insulin 24 Hour(12 weeks - from baseline to end of study)
- Total Nightime Basal Insulin(From baseline to 12 weeks)
- Total Daytime Basal Insulin(12 weeks - from baseline to end of study)
- Total Daily Bolus Insulin(12 weeks - from baseline to end of study)
- Mean Glucose(12 weeks - from baseline to end of study)
- Standard Deviation of Glucose(12 weeks - from baseline to end of study)
- Time Spent in Hypoglycemia(12 weeks - from baseline to end of study)
- Severe Hypoglycemia(From baseline to 12 weeks)
- Cholesterol(12 weeks - from baseline to end of study)
- HDL(12 weeks - from baseline to end of study)
- Albumin(12 weeks - from baseline to end of study)
- Zinc(12 weeks - from baseline to end of study)
- Carbohydrate Servings(12 weeks - from baseline to end of study)
- Heart Rate(12 weeks - from baseline to end of study)
- Free Fatty Acids(12 weeks - from baseline to end of study)
- Potassium(12 weeks - from baseline to end of study)
- Iron(12 weeks - from baseline to end of study)
- Transferrin(12 weeks - from baseline to end of study)
- IL-1(12 weeks - from baseline to end of study)
- Blood Glucose Readings(12 weeks - from baseline to end of study)
- Body Composition(12 weeks - from baseline to end of study)
- Diabetes Treatment Satisfaction(12 weeks - from baseline to end of study)
- Hypoglycemia Fear(12 weeks - from baseline to end of study)
- LDL(12 weeks - from baseline to end of study)
- Creatinine(12 weeks - from baseline to end of study)
- Thrombocytes(12 weeks - from baseline to end of study)
- U-alb-crea Ratio(12 weeks - from baseline to end of study)
- Hip Circumference(12 weeks - from baseline to end of study)
- Waist Circumference(From baseline to 12 weeks)
- Systolic Blood Pressure(12 weeks - from baseline to end of study)
- Diastolic Blood Pressure(12 weeks - from baseline to end of study)
- Triglycerides(12 weeks - from baseline to end of study)
- Urate(12 weeks - from baseline to end of study)
- Hemoglobin(12 weeks - from baseline to end of study)
- Leucocytes(12 weeks - from baseline to end of study)
- Ferritin(12 weeks - from baseline to end of study)
- Folate(12 weeks - from baseline to end of study)
- TNF-alpha(12 weeks - from baseline to end of study)
- Sodium(12 weeks - from baseline to end of study)
- Vitamin B-12(12 weeks - from baseline to end of study)
- IL-8(12 weeks - from baseline to end of study)
- CRP(12 weeks - from baseline to end of study)
研究者
Signe Schmidt
MD PhD
Copenhagen University Hospital, Hvidovre
研究点 (2)
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