Alimentation and Diabetes in Lanzarote - ADILAN: a Randomized Cross-over Pilot Trial Comparing a Healthy Diet With Grains and Dairy to a Healthy Diet Without Grains and Dairy in Patients With Type 2 Diabetes
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
- Fasting glucagon
研究概览
简要总结
The purpose of this study is to compare two healthy diets (according to official Spanish guidelines) that have been shown to be effective in the treatment of type 2 diabetes in order to see if one is better than the other.
Another goal is to test the hypothesis that food choice has metabolic effects that are independent of macro/micronutrient composition, fiber content, glycemic load and weight loss in the treatment of type 2 diabetes.
详细描述
There is some uncertainty with respect to the optimal dietary treatment of type 2 diabetes. In addition to energy balance, macronutrient composition, dietary fiber and glycemic load, increasing evidence suggests that the direct endocrine effects of food may be important.
In this trial, the intervention is based on two diets. The healthy diet with grains and dairy is based on whole grains, low-fat dairy, fish, shellfish, fruit, vegetables, legumes, eggs, nuts and refined vegetable oils rich in monounsaturated fatty acids (this is called "healthy diet A"). The healthy diet without grains and dairy is based on fish, shellfish, lean meat, fruit, vegetables, root vegetables, eggs and nuts, but excludes grains, legumes, refined vegetable oils, dairy products and salt (this is called "healthy diet B"). Both diets were classified as very healthy using validated nutritional software, and are considered healthy regarding macronutrient composition, fiber, mineral and vitamin intake according to the official Spanish dietary guidelines. The macro and micronutrient ratios, fiber content and glycemic load in healthy diet A and healthy diet B have been set to be equal.
The goal is to include 15 patients (>18 years) with medical diagnosis of type 2 diabetes, with or without medication, and increased waist circumference (≥80 cm for women and ≥94 cm for men), to a cross-over trial during two periods of 4-weeks separated by a 6-week washout period.
Lunch will be served in a hospital kitchen for control of nutrient intake, while the rest of meals will be eaten at home according to specific directions.
The working hypothesis of this study is that food choice has beneficial effects on the control of glucose beyond macro/micronutrient composition, fiber content, glycemic load and weight loss.
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
- •Medical diagnosis of type 2 diabetes
- •Increased waist circumference (≥80 cm for women and ≥94 cm for men)
- •Unaltered medical diabetes treatment since three months before start of study
- •Stable weight (varied less than 5%) since three months before start of study
- •HbA1c ≥6.0%
排除标准
- •Creatinine >130 μmol/L
- •Change of treatment with betablocker last 3 months
- •Change of treatment with thyroid hormone substitution last 3 months
- •Treatment with anticoagulant medication
- •Oral or injected steroid treatment
- •Elevated liver enzymes (AST, ALT, ALP, GPT > 4 times their respective upper reference value)
- •Physical or psychical illness, or changes in personal circumstances that make it impossible for the patient to continue in the study
结局指标
主要结局
Fasting glucagon
时间窗: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Fasting fructosamine
时间窗: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
次要结局
- Sagittal abdominal diameter(To be assessed at baseline and after 4, 10 and 14 weeks)
- Area under the curve for glucose (AUC glucose0-120) at the oral glucose tolerance test(Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks)
- Area under the curve for glucagon (AUC glucagon0-120) at the oral glucose tolerance test(Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks)
- Triglycerides(Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks)
- Low-density lipoprotein (LDL) cholesterol(Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks)
- Fasting plasma glucose(Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks)
- Total cholesterol(Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks)
- High-density lipoprotein (HDL) cholesterol(Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks)
- Systolic and diastolic blood pressure(To be assessed at baseline and after 4, 10 and 14 weeks)
- High-sensitive C-reactive protein(Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks)
- Waist circumference(To be assessed at baseline and after 4, 10 and 14 weeks)
- Hip circumference(To be assessed at baseline and after 4, 10 and 14 weeks)
- Tricipital, bicipital, suprailiac and subscapular skinfold thickness(To be assessed at baseline and after 4, 10 and 14 weeks)
- Satiation measured on a likert scale at food intake during 4 consecutive days(To be assessed at baseline and after 4, 10 and 14 weeks)
- Quality of life using a validated spanish version of the SF-36 questionnaire(To be assessed at baseline and after 4, 10 and 14 weeks)
- Change in medication(To be assessed at baseline and after 4, 10 and 14 weeks)
- Body weight(To be assessed at baseline and after 4, 10 and 14 weeks)
- Fasting HbA1c(Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks)
研究者
Maelán Fontes-Villalba
PhD Student
Lund University