NCT03194009

PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment

Public Healthcare Systems and Diabetes Prevention Among People of Mexican Origin: The PRuDENTE Initiative of Mexico City.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,060 (estimated)
• Sponsor: Instituto Nacional de Salud Publica, Mexico · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 2
• Prediabetic State

Interventions

Type	Name	Description
DRUG	Metformin	The patient will received metformin 1 tablet of 850mg every 12 hrs besides lifestyle modification recommendations
BEHAVIORAL	Lifestyle intervention	The patient will received recommendations to modify their diet and increase their physical activity every three months towards prevention of diabetes

Timeline

• Start date: 2017-08-10
• Primary completion: 2020-12-31
• Completion: 2022-12-31
• First posted: 2017-06-21
• Last updated: 2018-03-07

Locations

1 site across 1 country: Mexico