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Metabolic Syndrome and Leptin Level Associated With Fructose Consumption in Spain

This study has been completed.
Sponsor:
Information provided by:
Hospital Mateo Orfila
ClinicalTrials.gov Identifier:
NCT00651001
First received: March 28, 2008
Last updated: August 3, 2009
Last verified: August 2009
History of Changes
  Purpose

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.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Prevalence of Cardiovascular Risk Factors in Minorca - Spain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Mateo Orfila:

Primary Outcome Measures:
  • Serum leptin levels as it relates to fructose intake [ Time Frame: Epidemiological association ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum and urine collections.


Estimated Enrollment: 800
Study Start Date: June 2008
Estimated Study Completion Date: June 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

800 Adults, age 18 to 70

Criteria

Inclusion Criteria:

  • Adults, 18-70 years of age

Exclusion Criteria:

  • Diabetes
  • Kidney Failure
  • Heart Failure
  • Cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651001

Locations
Spain
Renal Unit of Mateo Orfila Hospital, Balearic Islands - Spain
Menorca, Balearic Islands, Spain, 07703
Sponsors and Collaborators
Hospital Mateo Orfila
  More Information

No publications provided

Responsible Party: Perez-Pozo, Santos E. Lopez-Lillo, Julian. Johnson, Richard, Hospital Mateo Orfila, University of Florida
ClinicalTrials.gov Identifier: NCT00651001     History of Changes
Other Study ID Numbers: IbSalut-M-002
Study First Received: March 28, 2008
Last Updated: August 3, 2009
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Mateo Orfila:
fructose
leptin
metabolic syndrome
blood pressure
inflammation
 Relationship of fructose intake to leptin levels
Relationship of fructose to metabolic syndrome
Relationship of fructose to inflammation parameters
Relationship of fructose to blood pressure

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013