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

March 5, 2018 updated by: Simon Barquera, Instituto Nacional de Salud Publica, Mexico

Public Healthcare Systems and Diabetes Prevention Among People of Mexican Origin: The PRuDENTE Initiative of Mexico City.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

3060

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Luz María Sánchez-Romero, MD, PhD
  • Phone Number: 4144 +52 (55) 54871000
  • Email: luz.sanchez@insp.mx

Study Contact Backup

Study Locations

  • Mexico
      • Mexico City, Mexico, 06820
        • Recruiting
        • Centros de Salud. Secretaría de Salud Ciudad de México
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
3 years
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
Will be evaluated every 3 months during the 36 month period
Caloric intake
Time Frame: Every 3 months during the 36 month period
From food-frequency questionnaires.
Every 3 months during the 36 month period
Physical Activity
Time Frame: Every 3 months during the 36 month period
Expresses ad the average metabolic equivalents (METs)-hours/week
Every 3 months during the 36 month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years
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.
5 years
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.
5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Salud Publica, Mexico

Collaborators

University of California, San Francisco
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Ministry of Health, Mexico City

Investigators

  • Principal Investigator: Simón Barquera, MD, PhD, Instituto Nacional de Salud Publica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (Actual)

June 21, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102/100/00/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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