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PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment (PRuDENTE)

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ClinicalTrials.gov Identifier: NCT03194009
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : August 18, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Prediabetic State Drug: Metformin Behavioral: Lifestyle intervention

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3060 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
Official Title: PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment
Actual Study Start Date : August 10, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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).
Drug: Metformin
The patient will received metformin 1 tablet of 850mg every 12 hrs besides lifestyle modification recommendations


Outcome Measures

Primary Outcome Measures :
  1. 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%

  2. 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

  3. Caloric intake [ Time Frame: Every 3 months during the 36 month period ]
    From food-frequency questionnaires.

  4. Physical Activity [ Time Frame: Every 3 months during the 36 month period ]
    Expresses ad the average metabolic equivalents (METs)-hours/week


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Luz María Sánchez-Romero, MD, PhD +52 (55) 54871000 ext 4144 luz.sanchez@insp.mx
Contact: Alberto Gallardo, MD +52 (55) 50381700 ext 1597 albgallardo@yahoo.com.mx

Locations
Mexico
Centros de Salud. Secretaría de Salud Ciudad de México Recruiting
Mexico City, Mexico, 06820
Contact: Alberto Gallardo, MD    +52 (55) 50381700 ext 1597    albgallardo@yahoo.com.mx   
Contact: Carmen Vanegas, MD    +52(55) 50381700 ext 1067    carmenvanegas_5@hotmail.com   
Sponsors and Collaborators
Instituto Nacional de Salud Publica, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Ministry of Health, Mexico City
University of California, San Francisco
Investigators
Principal Investigator: Simón Barquera, MD, PhD Instituto Nacional de Salud Pública
More Information

Responsible Party: Simon Barquera, Director Nutrition and Health Research Center (CINyS), Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier: NCT03194009     History of Changes
Other Study ID Numbers: 102/100/00/16
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Simon Barquera, Instituto Nacional de Salud Publica, Mexico:
diabetes
prevention
metformin
Mexico City

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs