PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment
PRuDENTE
Public Healthcare Systems and Diabetes Prevention Among People of Mexican Origin: The PRuDENTE Initiative of Mexico City.
1 other identifier
interventional
3,060
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Aug 2017
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2017
CompletedFirst Posted
Study publicly available on registry
June 21, 2017
CompletedStudy Start
First participant enrolled
August 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 7, 2018
March 1, 2018
3.4 years
June 2, 2017
March 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (4)
Implementation process outcomes at the clinic level. Using a questionnaire
5 years
Implementation process outcomes at the clinician level. Using a questionnaire
5 years
Implementation process outcomes patient level. Assess via questionnaire
5 years
Cost-utility of Metformin. Measured using cost per QALYS
5 years
Study Arms (2)
Lifestyle Intervention
ACTIVE COMPARATORThe 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 COMPARATORThe prediabetic individuals from the primary care centres that belong to this arm, will receive metformin treatment and lifestyle modifications recommendations (physical activity and diet).
Interventions
The patient will received metformin 1 tablet of 850mg every 12 hrs besides lifestyle modification recommendations
The patient will received recommendations to modify their diet and increase their physical activity every three months towards prevention of diabetes
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centros de Salud. Secretaría de Salud Ciudad de México
Mexico City, 06820, Mexico
Related Publications (1)
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.
PMID: 32580032DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simón Barquera, MD, PhD
Instituto Nacional de Salud Pública
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Nutrition and Health Research Center (CINyS)
Study Record Dates
First Submitted
June 2, 2017
First Posted
June 21, 2017
Study Start
August 10, 2017
Primary Completion
December 31, 2020
Study Completion
December 31, 2022
Last Updated
March 7, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share