Clinical trial NCT03194009: PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment
Official title: Public Healthcare Systems and Diabetes Prevention Among People of Mexican Origin: The PRuDENTE Initiative of Mexico City.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Prediabetic State
Keywords: diabetes
prevention
metformin
Mexico City
Lead sponsor: Instituto Nacional de Salud Publica, Mexico
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Ministry of Health, Mexico City
name: University of California, San Francisco
First posted: 2017-06-21
Enrollment: 3060
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Primary health care clinics will be allocated to one of the two arms of the intervention. A) lifestyle modification, B) Metformin and lifestyle modification
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

* 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.

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

Primary outcomes:
measure: Diabetes. measured by HbA1c and Fasting blood glucose (FBG)
timeFrame: 3 years
measure: Lifestyle modifications by decreasing adiposity indicators
timeFrame: Will be evaluated every 3 months during the 36 month period
measure: Caloric intake
timeFrame: Every 3 months during the 36 month period
measure: Physical Activity
timeFrame: Every 3 months during the 36 month period
Secondary outcomes:
measure: Implementation process outcomes at the clinic level. Using a questionnaire
timeFrame: 5 years
measure: Implementation process outcomes at the clinician level. Using a questionnaire
timeFrame: 5 years
measure: Implementation process outcomes patient level. Assess via questionnaire
timeFrame: 5 years
measure: Cost-utility of Metformin. Measured using cost per QALYS
timeFrame: 5 years
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Centros de Salud. Secretaría de Salud Ciudad de México
Study officials:
affiliation: Instituto Nacional de Salud Pública
name: Simón Barquera, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodriguez LA, Barquera S, Aguilar-Salinas CA, Sepulveda-Amor J, Sanchez-Romero LM, Denova-Gutierrez E, Balderas N, Moreno-Loaeza L, Handley MA, Basu S, Lopez-Arellano O, Gallardo-Hernandez A, Schillinger D. Design of a cluster-randomized trial of the effectiveness and cost-effectiveness of metformin on prevention of type 2 diabetes among prediabetic Mexican adults (the PRuDENTE initiative of Mexico City). Contemp Clin Trials. 2020 Aug;95:106067. doi: 10.1016/j.cct.2020.106067. Epub 2020 Jun 21.