Type 2 Diabetes Prevention
PIZARRA
Prevention of Type 2 Diabetes Mellitus (Egabro-Pizarra Study)
2 other identifiers
interventional
390
0 countries
N/A
Brief Summary
It will be selected 1274 subject older than 40 years of the population of Cabra in order to realize a sociodemographic and habits (toxic, food, of physical activity) survey. It will be realized a physical exploration including anthropometry, blood pressure, oral glucose tolerance test, blood extractions (basal and after 120 ' of the OGTT). Several biochemical determinations will be realized (p.e. marker of fat intake and marker of inflammation) The proposed intervention consists of a series of clinical visits and phone calls programmed with the aim to change the dietetic and physical activity habits of people. The Pizarra study (financed with other grants and realised with the same methodology) will be use as cohort control. Though the basic aim of the project is to achieve a reduction of the of diabetes incidence with a hygienic - sanitary intervention, the ambition of knowing the major number of possible factors that can participate in this process constitutes a complex project capable of analyzing the problem from diverse points of view. Endocrinologists (of two Andalusian hospitals), clinical biochemists, geneticists and dietitians they join in this project to approach an integral way the etiopathogeny of the diabetes type 2.
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 Jan 2009
Longer than P75 for not_applicable diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 25, 2015
CompletedFirst Posted
Study publicly available on registry
September 7, 2015
CompletedSeptember 9, 2015
May 1, 2015
5 years
May 25, 2015
September 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of type 2 diabetes in subjects at risk
Incidence (at 12 and 24 months) of type 2 diabetes diagnosed by oral glucose tolerance test (OGTT) according WHO criteria in subjects with impaired OGTT.
12 and 24 months
Study Arms (2)
Control
ACTIVE COMPARATORGeneral dietary and physical exercise recommendations
Intervention
EXPERIMENTALIntensive intervention on dietary and physical exercise habits.
Interventions
General recommendations about a healthy diet and physical activity and referral to their general physician with a report of the study results in the event of detecting any risk factor or pathological finding
Based on office visits each 3 months during the first year, as well as monthly telephone calls during the first year. Each subject will also attend a group educational meeting each 6 months. At each visit they will be given a series of recommendations and their degree of adherence evaluated and the evolution of their weight checked. The recommendations are designed to re-educate the subjects concerning their dietary and physical activity habits
Eligibility Criteria
You may qualify if:
- impaired fasting glucose and/or impaired oral glucose tolerance test.
You may not qualify if:
- type 2 diabetes mellitus previously diagnosed. In the last 6 months: serious illness or surgery, delivery or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GEMMA ROJO-MARTINEZ, PhD
Hospital Regional Universitario de Málaga (Spain)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2015
First Posted
September 7, 2015
Study Start
January 1, 2009
Primary Completion
January 1, 2014
Study Completion
January 1, 2015
Last Updated
September 9, 2015
Record last verified: 2015-05