- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00651001
Metabolic Syndrome and Leptin Level Associated With Fructose Consumption in Spain
August 3, 2009 updated by: Hospital Mateo Orfila
Prevalence of Cardiovascular Risk Factors in Minorca - Spain
A Food Frequency Questionnaire (FFQ), will be provided to 800 adults to assess overall fructose intake and this will be related to a number of features related to the metabolic syndrome, including serum leptin, characteristic features of metabolic syndrome (body mass index, waist circumference, plasma lipids, blood pressure, HOMA index,fasting glucose and fasting insulin levels) and other as: CRP, fibrinogen, homocysteine and uric acid.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Balearic Islands
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Menorca, Balearic Islands, Spain, 07703
- Renal Unit of Mateo Orfila Hospital, Balearic Islands - Spain
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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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
800 Adults, age 18 to 70
Description
Inclusion Criteria:
- Adults, 18-70 years of age
Exclusion Criteria:
- Diabetes
- Kidney Failure
- Heart Failure
- Cancer
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum leptin levels as it relates to fructose intake
Time Frame: Epidemiological association
|
Epidemiological association
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relationship of metabolic syndrome features with fructose intake. This includes measuring all 5 components of metabolic syndrome, assessing insulin resistance by HOMA, and measuring some markers of inflammation (CRP, fibrinogen, homocysteine)
Time Frame: Epidemiological
|
Epidemiological
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
June 1, 2008
Primary Completion (Actual)
January 1, 2009
Study Completion
June 1, 2009
Study Registration Dates
First Submitted
March 28, 2008
First Submitted That Met QC Criteria
April 1, 2008
First Posted (Estimate)
April 2, 2008
Study Record Updates
Last Update Posted (Estimate)
August 6, 2009
Last Update Submitted That Met QC Criteria
August 3, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IbSalut-M-002
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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