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PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment

NCT03194009 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3060

Last updated 2018-03-07

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2
  • Prediabetic State

Interventions

DRUG

Metformin

The patient will received metformin 1 tablet of 850mg every 12 hrs besides lifestyle modification recommendations

BEHAVIORAL

Lifestyle intervention

The patient will received recommendations to modify their diet and increase their physical activity every three months towards prevention of diabetes

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    collaborator OTHER

  • Ministry of Health, Mexico City

    collaborator UNKNOWN

  • University of California, San Francisco

    collaborator OTHER

  • Instituto Nacional de Salud Publica, Mexico

    lead OTHER

Principal Investigators

  • Simón Barquera, MD, PhD · Instituto Nacional de Salud Pública

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-10
Primary Completion
2020-12-31
Completion
2022-12-31

Countries

  • Mexico

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03194009 on ClinicalTrials.gov