Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/04/2010
Date assigned
20/04/2010
Last edited
20/04/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Emilio Ros

ORCID ID

Contact details

Endocrinology and Nutrition Service
Hospital Clinic of Barcelona
Barcelona
08036
Spain
+34 (0)93 2279383
EROS@clinic.ub.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

B2010-1

Study information

Scientific title

Prevalence of the metabolic syndrome and its components in relation to lifestyle in a Spanish community cohort: A cross sectional study

Acronym

DETECTA

Study hypothesis

The metabolic syndrome is a cluster of cardio-metabolic risk factors closely linked to abdominal obesity and insulin resistance that considerably increases the risk of cardiovascular disease and diabetes and is reported to affect close of 25% of the population worldwide. The global obesity epidemic, associated with unhealthy diets and sedentariness, is also present in Spain, where a high frequency of the metabolic syndrome is predicted. This topic has only been partially investigated, no data for the overall Spanish population is available, and associations with socioeconomic and lifestyle factors have not been assessed. We hypothesised an overall 30% prevalence of the metabolic syndrome closely related to age, socioeconomic status and lifestyle.

Ethics approval

The institutional review board of the Hospital Clinic of Barcelona approved on the 11th of March 2010 (ref: 2010/5674)

Study design

Cross-sectional study

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

GP practices

Trial type

Other

Patient information sheet

Not available in web format, please use contact Anna Munoz [anna.munoz@solvay.com] to request a patient information sheet

Condition

Obesity; metabolic syndrome; cardiovascular risk factors; lifestyle (including physical exercise and dietary variables)

Intervention

1. Clinical history
2. Anthropometric, adiposity and blood pressure measurements
3. Dietary and physical activity questionnaires

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Prevalence and geographical distribution of the metabolic syndrome (updated National Cholesterol Education Program Adult Treatment Panel [NCEP ATP] III definition) by:
1. Gender
2. Age ranges 21-40, 41-60 and 61-80 years

Secondary outcome measures

Prevalence of the metabolic syndrome by
1. Ethnic group (definition in immigrants based on waist circumference cut offs defined for different continents)
2. Socioeconomic status
3. Urban or rural residence
4. Main usual diet components
5. Alcohol consumption
6. Physical activity level
7. Smoking status

Overall trial start date

01/05/2010

Overall trial end date

30/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women aged 21-80 years attending family practices throughout Spain
2. Consulting for reasons other than the evaluation or control of cardio-metabolic risk factors or diabetes
3. Blood chemistry including fasting glucose and a lipid profile within the prior 6 months
4. Signed and informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10,000

Participant exclusion criteria

1. Type 1 diabetes
2. Severe chronic disease
3. Active non-skin cancer or cancer surgery within the previous 2 years
4. Prior organ transplantation and/or immunosuppressive treatment
5. Major surgery within the prior 3 months
6. Major psychiatric illness
7. Alcoholism or drug abuse
8. Known positive HIV status
9. Gain or loss of 5 or more kg within the last 3 months, voluntarily or because of illness
10. Inability to understand the purpose of the study

Recruitment start date

01/05/2010

Recruitment end date

30/04/2011

Locations

Countries of recruitment

Spain

Trial participating centre

Endocrinology and Nutrition Service
Barcelona
08036
Spain

Sponsor information

Organisation

Abbott Healthcare S.A. (Spain)

Sponsor details

Avda Diagonal 507
Barcelona
08029
Spain

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Abbott Healthcare S.A. (Spain) - unrestricted grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes