Diabetes Mellitus, Type 2, Prediabetic State
Conditions
Keywords
diabetes, prevention, metformin, Mexico City
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.
Interventions
DRUGMetformin
The patient will received metformin 1 tablet of 850mg every 12 hrs besides lifestyle modification recommendations
BEHAVIORALLifestyle intervention
The patient will received recommendations to modify their diet and increase their physical activity every three months towards prevention of diabetes
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Ministry of Health, Mexico City
University of California, San Francisco
Instituto Nacional de Salud Publica, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | Every 3 months during the 36 month period | Expresses ad the average metabolic equivalents (METs)-hours/week |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Mexico
Contacts
Primary ContactLuz María Sánchez-Romero, MD, PhD
Backup ContactAlberto Gallardo, MD
Outcome results
None listed