PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment (PRuDENTE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03194009|
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Prediabetic State||Drug: Metformin Behavioral: Lifestyle intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3060 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Masking:||None (Open Label)|
|Official Title:||Public Healthcare Systems and Diabetes Prevention Among People of Mexican Origin: The PRuDENTE Initiative of Mexico City.|
|Actual Study Start Date :||August 10, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2022|
Active Comparator: 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).
Behavioral: Lifestyle intervention
The patient will received recommendations to modify their diet and increase their physical activity every three months towards prevention of diabetes
Active Comparator: 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).
The patient will received metformin 1 tablet of 850mg every 12 hrs besides lifestyle modification recommendations
- Diabetes. measured by HbA1c and Fasting blood glucose (FBG) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Every 3 months during the 36 month period ]From food-frequency questionnaires.
- Physical Activity [ Time Frame: Every 3 months during the 36 month period ]Expresses ad the average metabolic equivalents (METs)-hours/week
- Implementation process outcomes at the clinic level. Using a questionnaire [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 5 years ]Analyse the cost-utility of the implementation of this intervention in primary-care health. Using direct and indirect health-care cost data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194009
|Contact: Luz María Sánchez-Romero, MD, PhD||+52 (55) 54871000 ext email@example.com|
|Contact: Alberto Gallardo, MD||+52 (55) 50381700 ext firstname.lastname@example.org|
|Centros de Salud. Secretaría de Salud Ciudad de México||Recruiting|
|Mexico City, Mexico, 06820|
|Contact: Alberto Gallardo, MD +52 (55) 50381700 ext 1597 email@example.com|
|Contact: Carmen Vanegas, MD +52(55) 50381700 ext 1067 firstname.lastname@example.org|
|Principal Investigator:||Simón Barquera, MD, PhD||Instituto Nacional de Salud Pública|