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| Name | Class |
|---|---|
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | OTHER |
| Ministry of Health, Mexico City | UNKNOWN |
| University of California, San Francisco | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Intervention | Active Comparator | 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 | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | The patient will received metformin 1 tablet of 850mg every 12 hrs besides lifestyle modification recommendations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes. measured by HbA1c and Fasting blood glucose (FBG) | We define type 2 diabetes (T2D) as either FBG 100-125 mg/dl or HbA1c of >= 6.5% | 3 years |
| Lifestyle modifications by decreasing adiposity indicators | We will evaluate this by : weight in Kg, height in mts. They also be combined to report BMI/m2, and waist circumference | Will be evaluated every 3 months during the 36 month period |
| Caloric intake | From food-frequency questionnaires. | Every 3 months during the 36 month period |
| Physical Activity | Expresses ad the average metabolic equivalents (METs)-hours/week | Every 3 months during the 36 month period |
| Measure | Description | Time Frame |
|---|---|---|
| Implementation process outcomes at the clinic level. Using a questionnaire | 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 |
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Inclusion Criteria:
Optional:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luz MarÃa Sánchez-Romero, MD, PhD | Contact | +52 (55) 54871000 | 4144 | luz.sanchez@insp.mx |
| Alberto Gallardo, MD | Contact | +52 (55) 50381700 | 1597 | albgallardo@yahoo.com.mx |
| Name | Affiliation | Role |
|---|---|---|
| Simón Barquera, MD, PhD | Instituto Nacional de Salud Pública | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centros de Salud. SecretarÃa de Salud Ciudad de México | Recruiting | Mexico City | 06820 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32580032 | Derived | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D011236 | Prediabetic State |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Primary health care clinics will be allocated to one of the two arms of the intervention. A) lifestyle modification, B) Metformin and lifestyle modification
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| Lifestyle intervention | Behavioral | The patient will received recommendations to modify their diet and increase their physical activity every three months towards prevention of diabetes |
|
| 5 years |
| Implementation process outcomes at the clinician level. Using a questionnaire | 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. | 5 years |
| Implementation process outcomes patient level. Assess via questionnaire | Assess the implementation process at the patient-levels using a questionnaire that show data regarding adherence to treatment and lifestyle modifications. | 5 years |
| Cost-utility of Metformin. Measured using cost per QALYS | Analyse the cost-utility of the implementation of this intervention in primary-care health. Using direct and indirect health-care cost data. | 5 years |