Metabolic Syndrome and Leptin Level Associated With Fruct... | NCT00651001

Studies
Metabolic Syndrome and Leptin Level Associated With Fructose Consumption in Spain

NCT00651001

Sponsor

Hospital Mateo Orfila

Status

Completed

Last Update Posted

Aug 6, 2009Estimated

Enrollment

800Estimated

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Jun 2009

First Submitted Date

Mar 28, 2008

First Submission Date that Met QC Criteria

Apr 1, 2008

First Posted Date

Apr 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2009

Last Update Posted Date

Aug 6, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Conditions Module

Conditions

Healthy

Keywords

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

800Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum leptin levels as it relates to fructose intake		Epidemiological association

Secondary Outcomes

Measure	Description	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)		Epidemiological

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults, 18-70 years of age

Exclusion Criteria:

Diabetes
Kidney Failure
Heart Failure
Cancer

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

800 Adults, age 18 to 70

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renal Unit of Mateo Orfila Hospital, Balearic Islands - Spain		Menorca	Balearic Islands	07703	Spain

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome
D007249	Inflammation

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided