Public Healthcare Systems and Diabetes Prevention Among People of Mexican Origin: The PRuDENTE Initiative of Mexico City.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,060
- 试验地点
- 1
- 主要终点
- Diabetes. measured by HbA1c and Fasting blood glucose (FBG)
研究概览
简要总结
The PRuDENTE study proposes to assess if metformin therapy a viable, efficient and cost-effective intervention to decrease the incidence of type 2 diabetes (DMT2) in adult subjects with obesity and pre-diabetes in Mexico City. Half of the individuals recruited will receive as intervention, metformin and lifestyle modification therapy and the other half will receive only lifestyle modification therapy.
详细描述
Diabetes in Mexico is considered a national emergency given its high prevalence, incidence, mortality and costs. Mexico has one of the highest prevalence of diabetes; in only 6 years (2000 to 2006) this prevalence increased from 7.5% to 14.4%. In 2015, 151 deaths per 100,000 inhabitants occurred in Mexico due to diabetes complications.
Metformin is a hypoglycemia drug and it´s the first line medication for the treatment of type 2 diabetes.There is currently a significant amount of evidence that metformin administration reduces the progression from pre-diabetes to diabetes and, despite its monotherapy being less effective than lifestyle changes, the good biosafety profile and low cost have made it the drug of choice in a joint treatment.
The PRuDENTE study proposes to perform this intervention in a real environment in the clinics of the first level of care of the Ministry of Health of the Government of Mexico City, in order to provide evidence about the cost-effectiveness of metformin as a public health intervention for the prevention of diabetes.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having received primary care in the chosen health center (ideally two or more visits to that clinic in the prior year).
- •Subscribers to "Seguro Popular" ( Mexican national health insurance)
- •Body mass index >=30 kg / m2
- •Results of fasting serum glucose with values for pre-diabetes diagnosis (glucose between 100 and 125 mg / dl)
- •Family history of DMT2 (1st grade relative).
- •Previous diagnosis of hypertension or dyslipidaemia.
- •Have received antihypertensive medication and / or for cholesterol / lipids.
- •History of gestational diabetes mellitus.
排除标准
- •Renal insufficiency (Glomerular Filtration Rate (GFR) <30 ml/min).
- •Known hepatic impairment or altered liver enzymes (aspartate aminotransferase (AST) AST or alanine aminotransferase (ALT) three times above normal values)
- •Active alcoholism or drug addiction
- •Allergies or previous known intolerance to exercise or metformin.
- •Current pregnancy.
- •Plans to leave the area in the next three years.
- •Previous diagnosis of type 2 diabetes mellitus
研究组 & 干预措施
Lifestyle Intervention
The prediabetic individuals from the primary care centres that belong to this arm, will receive only recommendations for lifestyle modifications (physical activity and diet).
干预措施: Lifestyle intervention (Behavioral)
Metformin
The prediabetic individuals from the primary care centres that belong to this arm, will receive metformin treatment and lifestyle modifications recommendations (physical activity and diet).
干预措施: Metformin (Drug)
结局指标
主要结局
Diabetes. measured by HbA1c and Fasting blood glucose (FBG)
时间窗: 3 years
We define type 2 diabetes (T2D) as either FBG 100-125 mg/dl or HbA1c of \>= 6.5%
Lifestyle modifications by decreasing adiposity indicators
时间窗: Will be evaluated every 3 months during the 36 month period
We will evaluate this by : weight in Kg, height in mts. They also be combined to report BMI/m2, and waist circumference
Caloric intake
时间窗: Every 3 months during the 36 month period
From food-frequency questionnaires.
Physical Activity
时间窗: Every 3 months during the 36 month period
Expresses ad the average metabolic equivalents (METs)-hours/week
次要结局
- Implementation process outcomes at the clinic level. Using a questionnaire(5 years)
- Implementation process outcomes at the clinician level. Using a questionnaire(5 years)
- Cost-utility of Metformin. Measured using cost per QALYS(5 years)
- Implementation process outcomes patient level. Assess via questionnaire(5 years)
研究者
Simon Barquera
Director Nutrition and Health Research Center (CINyS)
Instituto Nacional de Salud Publica, Mexico