Effect on Glycemic Variability, Weight and Oxidative Stress Markers FGF 21 in a Low Calorie Diet of Three Meals Compared With a Conventional Low Calorie Plan of Six Meals in Patients With Type 2 Diabetes With Overweight or Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Impact of 3 stroke diet in glycemic variability compared to a 6 stroke diet
研究概览
简要总结
The frequency of meals is a very important aspect of nutrition, with profound effects on human health and in life expectancy. Excessive energy consumption is totally associated with a significant increase in the incidence of chronic diseases including diabetes. That is why nutritional therapy is recommended for all people with diabetes mellitus type 1 and 2 as an effective complement to your medical treatment. For overweight or obese type 2 diabetic patients, a low-calorie diet along with healthy eating patterns are recommended for weight loss. Similarly, modest body weight decrease may provide clinical benefits in patients, such as improved blood glucose, blood pressure, lipid profile, and others. Data about the role of nutritional habits and energy density being important precursors of obesity and diabetes are well known. On the other hand, data regarding frequency and timing of meals and how these factors relate to corporal weight are not totally understood.
详细描述
In general, hypocaloric plans for patients with type 2 diabetes mellitus are consumed in five or six small meals per day. Eating more often is presumed to reduce hunger and thus energy consumption. However, the effects of meal frequency on human health and longevity are unclear.
Therefore, this study will be carried out in which the differences in the impact of nutritional therapy between a hypocaloric conventional 6 times meal versus a 3-meal low-calorie plan will be demonstrated.
The procedures will be as follows:
50 patients with DM2 from the Institute's Diabetes Clinic who are overweight or obese and between 40 and 70 years of age and who are found to have oral hypoglycemic agents, HbA1c less than 9% and less than 10 years old will be recruited of evolution.
Clinical evaluation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Oral hypoglycemic agents
- •HbA1c <9%
- •Less than 10 years of evolution
- •Diabetes Mellitus type 2
- •Overweight or obese
- •Age 40-70 years
- •BMI ≥25 to < 40 kg/m
排除标准
- •Obesity 3rd grade
- •Hospitalization in the last 3 months
- •>10 years of evolution
- •HbA1c >9%
- •Pregnancy
结局指标
主要结局
Impact of 3 stroke diet in glycemic variability compared to a 6 stroke diet
时间窗: 12 weeks
Patients from both groups (3 stroke and 6 stroke diet) will be monitored for 7 days using intensive capillar blood glucose measurements 4 times per day (Fasting, 2 hours post breakfast, 2 hours post meal and 2 hours post dinner). The basal intensive blood glucose meaasurement monitoring will start at week 1 (first visit), and will end at day 7 and final intensive blood glucose meaasurement monitoring will start at week 11 and will end 7 days after (final visit) comparing glycemic variability between them. Mean difference of glycaemic variability (MAGE) calculated in mmol/L.
次要结局
- Impact of 3 stroke diet in fasting glucose levels compared to a 6 stroke diet(12 weeks)
- Impact of 3 stroke diet in cholesterol levels compared to a 6 stroke diet(12 weeks)
- Impact of 3 stroke diet in systolic and diastolic blood pressure compared to a 6 stroke diet(12 weeks)
- Impact of 3 stroke diet in triglycerides levels compared to a 6 stroke diet(12 weeks)
- Impact of 3 stroke diet in satiety compared to a 6 stroke diet(12 weeks)
- Impact of 3 stroke diet in glycosylated hemoglobin levels compared to a 6 stroke diet(12 weeks)
- Impact of 3 stroke diet in fibroblast growth factor 21 levels compared to a 6 stroke diet(12 weeks)
- Impact of 3 stroke diet in weight loss compared to a 6 stroke diet(12 weeks)
研究者
Miguel Ángel Gómez Sámano
MD
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran