Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Public Healthcare Systems and Diabetes Prevention Among People of Mexican Origin: The PRuDENTE Initiative of Mexico City.
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.
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