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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
3,060
The patient will received metformin 1 tablet of 850mg every 12 hrs besides lifestyle modification recommendations
The patient will received recommendations to modify their diet and increase their physical activity every three months towards prevention of diabetes
Centros de Salud. Secretaría de Salud Ciudad de México
Mexico City, Mexico
RECRUITINGDiabetes. measured by HbA1c and Fasting blood glucose (FBG)
We define type 2 diabetes (T2D) as either FBG 100-125 mg/dl or HbA1c of \>= 6.5%
Time frame: 3 years
Lifestyle modifications by decreasing adiposity indicators
We will evaluate this by : weight in Kg, height in mts. They also be combined to report BMI/m2, and waist circumference
Time frame: Will be evaluated every 3 months during the 36 month period
Caloric intake
From food-frequency questionnaires.
Time frame: Every 3 months during the 36 month period
Physical Activity
Expresses ad the average metabolic equivalents (METs)-hours/week
Time frame: Every 3 months during the 36 month period
Implementation process outcomes at the clinic level. Using a questionnaire
Assess the implementation process outcomes at the clinic-, clinician- and patient-levels that will explain the observed effectiveness, and enable future efforts to adapt and disseminate the intervention model across other primary care settings. A questionnaire will be develop to assess the feasibility and limitations for the longterm implementation of this intervention
Time frame: 5 years
Implementation process outcomes at the clinician level. Using a questionnaire
A questionnaire will be develop to assess the limitations of recruitment at the clinic . As well as to evaluate the feasibility of continuing this intervention in outside patients.
Time frame: 5 years
Implementation process outcomes patient level. Assess via questionnaire
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Assess the implementation process at the patient-levels using a questionnaire that show data regarding adherence to treatment and lifestyle modifications.
Time frame: 5 years
Cost-utility of Metformin. Measured using cost per QALYS
Analyse the cost-utility of the implementation of this intervention in primary-care health. Using direct and indirect health-care cost data.
Time frame: 5 years