Effect of Lifestyle Intervention on Incident Diabetes in Individuals With Impaired Fasting Glucose and Low or High Genetic Risk for the Development of Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Incident diabetes
研究概览
简要总结
The aim of the study is to compare the effect of lifestyle intervention (diet and physical activity) by applying modern approaches to lifestyle changes on the prevention of incident T2DM and the worsening of hyperglycemia in people with high number of T2DM risk alleles and in people with low number of T2DM risk alleles compared to corresponding control groups.
详细描述
AIM: The aim of the study is to compare the effect of lifestyle intervention (diet and physical activity) by applying modern approaches to lifestyle changes on the prevention of incident type 2 diabetes (T2DM) and the worsening of hyperglycemia in people with high number of T2DM risk alleles and in people with low number of T2DM risk alleles compared to corresponding control groups.
STUDY GROUPS. A total of 600 participants will be selected from the METabolic Syndrome In Men (METSIM) study. They are divided into two groups: a) high genetic risk for T2DM on the basis of the genetic risk score (N=300), and b) low genetic risk score for T2DM on the basis of the genetic risk score (N=300). For both of these groups a corresponding control group (N=300) will be selected.
PROTOCOL. 1) The first visit at entry (visit 1) for both intervention and control groups: an interview about physical activity at work and leisure time, smoking, alcohol use, education, occupation, diet, history of medication; clinical measurements: blood pressure, body weight, height, bioimpedance; laboratory measurements including an oral glucose tolerance test, fasting measurements (HbA1c, total cholesterol, HDL cholesterol, total triglycerides, ALT, GAD antibodies); 2) Group sessions (about 15 participants in each) 1-7 described below for the intervention group but not for the control group, 3) A 6 month and 24 month visits (identical to visit 1) for the intervention group but not for the control group; 4) A 3-year visit for both intervention and control groups (identical to visit 1).
Detailed protocol for the intervention group: Dietary guidance in the intervention group is based on the Nordic and Finnish nutrition recommendations and they emphasize appropriate energy intake, meal frequency, consumption of fruits vegetables and berriers, quality of dieatry fat and cardohydrates, including sugar and fiber intake. During the intervention the goals for nutrient and food intake (healthy diet) are: Vegetables, fruits and berries >= 500 g/day, carbohydrates 45-60 E%, sucrose < 10 E%, fiber >=35 g/day, fat 25-40 E%, saturated fat < 10 E%, unsaturated fat >= 2/3 of total fat E%, monosaturated fat 10-20 E%, polysaturated fat 5-10 E%, n-3 fatty acids >= 1E%. The goal for physical activity is brisk walking a minimum of 30 min/day at least five days a week. Walking could be replaced by other types of exercise (e.g. cycling, crioss-country skiing, resistance training, and housework such as leaft raking);
The first year of the intervention will be the most active and includes 4-6 group sessions depending on participants' needs. Group sessions for the intervention group:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participant of the METSIM Study
- •Impaired fasting glucose (IFG) at entry (fasting plasma glucose 5.6-6.9 mmol/l) and with (2-hour glucose 7.8-11.0 mmol/l) or without impaired glucose tolerance (2-hour glucose <7.8 mmol/l) and HbA1c < 6.5%.
- •Age 50-75 years
- •Body mass index ≥ 25 kg/m2
排除标准
- •Age < 50 years or > 75 years
- •Body mass index < 25 kg/m2
- •Type 1 or type 2 diabetes or isolated impaired glucose tolerance (2-hour plasma glucose < 5.6 mmol/l and 2-hour plasma glucose 7.8-11.0 mmol/l) or HbA1c ≥ 6.5%
- •Chronic diseases preventing to participate in the trial
结局指标
主要结局
Incident diabetes
时间窗: 3 years
Incident diabetes is defined by fasting plasma glucose ≥ 7.0 mmol/l or 2-hour glucose in an oral glucose tolerance test ≥ 11.1 mmol/l or HbA1c ≥ 6.5% or drug treatment started for diabetes during a 3-year follow-up.
次要结局
- The change in insulin secretion during a 3 year follow-up(3 years)
- The change in glucose area under the curve in an oral glucose tolerance test(3 years)
- The change in insulin sensitivity during a 3 year follow-up(3 years)
研究者
Markku Laakso
Professor
University of Eastern Finland