Efficacy of a Family and Interdisciplinary Intervention to Prevent Diabetes, and Effect on Family Profiles of Insulin Secretion and Insulin Resistance in Patients With Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Individual Insulin Resistance and Insulin Secretion
研究概览
简要总结
The purpose of the study is to evaluate the effect of a family and interdisciplinary approach on individual and family insulin resistance and insulin secretion in patients with prediabetes.
详细描述
This a randomized clinical trial designed to evaluate the efficacy of the following treatments:
- Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months
- Individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months
To improve individual and family insulin resistance and insulin secretion in patients with prediabetes.
Patients will have a follow-up visit every month in the Metabolic Research Laboratory at the University of Guanajuato, Mexico, and will have a fasting measurement of lipids, glucose and insulin every 3 months, as well as 2h oral glucose tolerance test (OGTT) at basal, 6 and 12 months.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with prediabetes (Fasting glucose 100-125mg/dl and/or 2h post OGTT glucose 140-199mg/dl)
- •Family of patients with prediabetes (in case of the patients that are randomized to FAMILY APPROACH)
- •Signing of the inform consent
排除标准
- •Type 2 diabetes
- •Pregnancy
- •Liver disease
- •Renal disease
研究组 & 干预措施
Family and interdisciplinary approach
Family and interdisciplinary approach: Patients in this group will receive a Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months
干预措施: Family and interdisciplinary approach (Other)
individual approach
individual approach: Patients in this group will receive individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months
干预措施: individual approach (Other)
结局指标
主要结局
Individual Insulin Resistance and Insulin Secretion
时间窗: 12 months
Whole body insulin sensitivity as determined by the Matsuda Index was calculated using the following formula: 10,000 divided by the square root of (FPI\* FPG) \* (xGPC\* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher values indicating better insulin sensitivity (better result, the higher the value the better the result of this variable). A value of 2.5 or less is indicative of low insulin sensitivity (worst result).
次要结局
- Family Insulin Resistance and Insulin Secretion (Matsuda Index Measured in the Relatives of the Patients)(12 months)
- Weight(12 months)
- 2h OGTT Glucose(6 and 12 months)
研究者
Rodolfo Guardado Mendoza
Titular Profesor A
Universidad de Guanajuato