Effect of the Genetic Variants Typical of the Mestizo Population That Confer Risk of Having Metabolic Diseases on the Response to Common Treatments (Diet, Physical Activity, Metformin, Exercise).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 437
- 试验地点
- 1
- 主要终点
- Change in weigth loss
研究概览
简要总结
The goal of this randomized clinical trial is to determine the impact of the risk haplotype on SLC16A11 on early therapeutic responses in treatments to prevent T2D in Mexican mestizos with prediabetes. The main question[s] it aims to answer are:
- Evaluate the effect of the risk haplotype on weigth loss >3%
- Evualuate the differences in lipid profiles and glycemic parameters (fasting glucose, HbA1c).
Participants will be randomized into two groups: lifestyle intervention (LSI): hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (>150 min medium intensity per week), or LSI + MET (750 mg metformin twice a day).
Researchers will compare carriers and non carriers of the risk haplotype of SLC16A11 to see if there are diferent treatment responses.
详细描述
Objectives: Dietary modification and/or metformin remain the most cost-effective treatment to prevent type 2 diabetes (T2D). Yet, there is an important variation in receiving the benefit among individuals. A haplotype in SLC16A11 is associated with decreased insulin action and risk for T2D in Mexicans. We aim to determine the impact of the risk haplotype on SLC16A11 on early therapeutic responses in treatments to prevent T2D.
Methods: We recrute individuals with at least one prediabetes criteria according to the American Diabetes Association with a body mass index (BMI) between 25 and 45 kg/m2. Participants are randomized into two groups: lifestyle intervention (LSI): hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (>150 min medium intensity per week), or LSI + MET (750 mg metformin twice a day). Standardized dietitians delivere the LSI. The treatment goal is to achieve >3% weight loss during the 12-week follow-up. Participants are genotyped for the risk allele rs13342232 and rs75493593. The effects of the risk haplotype are evaluated with linear and logistic regressions adjusted by age, sex, five genetic principal components, BMI, and prediabetes criteria at baseline. Primary outcome is a significant interaction between the treatment arm and genotype in weight loss goal >3% after the treatment. Secondary outcome are differences in lipid levels and third outcome is differences in glycemic parameters (fasting glucose, HbA1c).
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mexican mestizos
- •At least one prediabetes criteria according to the American Diabetes Association: fasting glucose between 100-124 mg/dL, Glycosylated hemoglobin (HbA1c) between 5.7-6.4, and 2-hour blood sugar between 140 mg/dl-199 mg/dl after an oral load of 75g of glucose) (1);
- •Age ranged between 18-65 years
- •Overweight or obesity (BMI between 25.0 - 40 kg/m2).
排除标准
- •Chronic diseases
- •Pregnancy
- •Chronic use of medications that altered plasma glucose levels.
研究组 & 干预措施
Life Style Intervention
Hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (>150 min medium intensity per week)
干预措施: Life Style Intervention (Behavioral)
Life Style Intervention + Metformin
Hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (>150 min medium intensity per week) + (750 mg metformin twice a day).
干预措施: Life Style Intervention + Metformin (Drug)
结局指标
主要结局
Change in weigth loss
时间窗: 12 weeks
Number of participants in each treatment arm reaching the the goal weight loss \>3%
次要结局
- Change in HbA1c(12 weeks)
- Change in ApoB(12 weeks)
- Change in NonHDL-Cholesterol(12 weeks)
- Change in fasting glucose(12 weeks)
- Change in Total-Cholesterol parameters(12 weeks)
- Change in LDL-Cholesterol parameters(12 weeks)