DANCE (Diabetes ANd CarbohydratEs). Does the Amount of Dietary Carbohydrates Affect Insulin Requirements and Metabolic Control in Type 1 Diabetes? Comparative Study of Traditional Diabetes, Moderately Low and Strictly Low Carbohydrate Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Change in insulin use
研究概览
简要总结
The scientific basis for dietary recommendations in type 1 diabetes is almost lacking, with the current recommendations being based on type 2 diabetes studies. Therefore the overall purpose of this study is to improve the current evidence for dietary recommendations to people with type 1 diabetes.
Study aim: To compare how a strictly low carbohydrate diet, a moderately low carbohydrate diet and a traditional diabetes diet (with higher amounts of carbohydrates) affect insulin requirements and metabolic control in individuals with type 1 diabetes.
Carbohydrate intake is 50-60% of the total energy intake in the traditional diabetes diet, 30-40% in the moderately low carbohydrate diet and 15-20% in the strictly low carbohydrate diet with a minimum of 50 g carbohydrates/day. A diet with less than 50 g carbohydrates/day is usually called very low carbohydrate diet or ketogenic and will not be tested in this study.
Those who wish to participate and meet the inclusion criteria (and none of the exclusion criteria) will be randomized to one of the three diets. The duration of the intervention is 6 months after which the participants will be able to choose their own diet for another 6 months. The main study visits are at baseline (screening and study start), 3, 6, 9, and 12 months. Shorter visits will be at 3 and 6 weeks. The participants will meet with a study nurse, dietitian and doctor. They will attend two carbohydrate counting courses before the start of the intervention in order to be able to match their insulin to the amount carbohydrates they eat. Participants will receive written materials about their diets with menus and recipes for better adherence to the diet.
The primary endpoint is the change in insulin requirements within and between groups (for secondary endpoints please see relevant section). For assessing the different endpoints the participants will provide blood, urine and feces samples for lab analyses as well as register their insulin use, blood glucose, diet, physical activity and any blood ketones or hypoglycemia electronically or in written forms. Continuous/flash glucose monitoring (CGM/FGM) will be also used. Dietary assessment and adherence will be based on 3-4 day food diaries before every scheduled study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Nurses that will take lab samples as well as laboratory personal that analyses the samples will be masked. Due to the nature of the study, it is not possible to mask the participants or the care providers/investigators.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To have had type 1 diabetes for at least 1 year
- •Age >=20 years old
排除标准
- •Cardiovascular disease NYHA class IIIB or more
- •Kidney disease > stadium 3
- •Liver disease, alanine aminotransferase (ALAT) ≥ 2 µkat/L,
- •BMI < 18.5 kg/m^2
- •c-peptide ≥ 0.3 nmol/l
- •Pregnant/breastfeeding women, women that plan to get pregnant during study period
- •Other circumstances, which, according to the examiner, make it difficult for an individual to participate.
研究组 & 干预措施
traditional diabetes diet
Participants in this arm will follow a diet with carbohydrate intake 50-60% of total energy intake
干预措施: traditional diabetes diet (Behavioral)
strictly low carbohydrate diet
Participants in this arm will follow a diet with carbohydrate intake 15-20% of total energy intake
干预措施: strictly low carbohydrate diet (Behavioral)
moderately low carbohydrate diet
Participants in this arm will follow a diet with carbohydrate intake 30-40% of total energy intake
干预措施: moderately low carbohydrate diet (Behavioral)
结局指标
主要结局
Change in insulin use
时间窗: screening, day 0, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
measured in international units (IU) and percentage.
次要结局
- Change in HbA1c(screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months)
- Change in concentration of triglycerides(screening, 3 months, 6 months, 9 months, 12 months)
- Ratio of LDL/HDL(screening, 3 months, 6 months, 9 months, 12 months)
- Change in weight(screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months)
- Concentration of high sensitivity c-Reactive Protein (Hs-CRP)(screening, 3 months, 6 months, 9 months, 12 months)
- Change in concentration of total cholesterol(screening, 3 months, 6 months, 9 months, 12 months)
- Change in concentration of HDL-cholesterol(screening, 3 months, 6 months, 9 months, 12 months)
- Change in markers of glycemic variability (TIR, TAR, TBR, mean sensor glucose with SD, CV)(screening, 3 months, 6 months, 9 months, 12 months)
- Change in microalbuminuria(screening, 3 months, 6 months, 9 months, 12 months)
- Concentration of glucagon(screening, 3 months, 6 months, 9 months, 12 months)
- Change in abdominal circumference(screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months)
- Concentration of Insulin-like Growth Factor - binding protein 1 (IGFBP-1)(screening, 3 months, 6 months, 9 months, 12 months)
- Score from the Short Form 36 (SF-36) questionnaire(screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months)
- Change in BMI(screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months)
- Concentration of Insulin-like Growth Factor 1 (IGF-I)(screening, 3 months, 6 months, 9 months, 12 months)
- Concentration of leptin(screening, 3 months, 6 months, 9 months, 12 months)
- Concentration of adiponectin(screening, 3 months, 6 months, 9 months, 12 months)
- Concentration of interleukin 6 (IL-6)(screening, 3 months, 6 months, 9 months, 12 months)
- Concentration of Oxidized LDL(screening, 3 months, 6 months, 9 months, 12 months)
- Total Antioxidant Capacity (TAC)(screening, 3 months, 6 months, 9 months, 12 months)
- Plasma metabolites assessed by untargeted liquid chromatography - mass spectrometry (LC-MS) metabolomics(screening, 3 months, 6 months, 9 months, 12 months)
- Change in concentration of LDL-cholesterol(screening, 3 months, 6 months, 9 months, 12 months)
- Change in concentration of p-creatinine(screening, 3 months, 6 months, 9 months, 12 months)
- Change in estimated Glomerular Filtration Rate (eGFR)(screening, 3 months, 6 months, 9 months, 12 months)
- Measurement of lipopolysaccharides (LPS) activity using the Limulus Amebocyte Lysate (LAL) assay(screening, 3 months, 6 months, 9 months, 12 months)
- Concentration of reactive oxygen species (ROS)(screening, 3 months, 6 months, 9 months, 12 months)
- Concentration of glutaredoxin 1 (GRX-1)(screening, 3 months, 6 months, 9 months, 12 months)
- Time taken to complete the Trail making test A+B(screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months)
- Score from the Well-being Questionnaire-12 (WBQ-12)(screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months)
- Score from the Diabetes Treatment Satisfaction Questionnaire (DTSQ)(screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months)
研究者
Anneli Björklund
Principal Investigator, Senior Consultant, Associate Professor
Karolinska Institutet