PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment

Not Applicable

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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)

Optional:

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention	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).
Metformin	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).

Primary Outcome Measures

Name	Time	Method
Diabetes. measured by HbA1c and Fasting blood glucose (FBG)	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	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	Every 3 months during the 36 month period	From food-frequency questionnaires.
Physical Activity	Every 3 months during the 36 month period	Expresses ad the average metabolic equivalents (METs)-hours/week

Secondary Outcome Measures

Name	Time	Method
Implementation process outcomes at the clinic level. Using a questionnaire	5 years	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
Implementation process outcomes at the clinician level. Using a questionnaire	5 years	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.
Cost-utility of Metformin. Measured using cost per QALYS	5 years	Analyse the cost-utility of the implementation of this intervention in primary-care health. Using direct and indirect health-care cost data.
Implementation process outcomes patient level. Assess via questionnaire	5 years	Assess the implementation process at the patient-levels using a questionnaire that show data regarding adherence to treatment and lifestyle modifications.

Locations (1): Centros de Salud. Secretaría de Salud Ciudad de México
🇲🇽
Mexico City, Mexico