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Cardiovascular Risk Factors and LCH in Adults

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2007 by Laikon General District Hospital, Athens.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00483925
First Posted: June 8, 2007
Last Update Posted: June 8, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Laikon General District Hospital, Athens
  Purpose

Langerhans-cell histiocytosis (LCH) is a rare disease with features of chronic inflammation and hypopituitarism, conditions associated with increased risk of cardiovascular diseases.

Objective: To investigate glucose and lipid metabolism, insulin resistance, structural arterial and functional endothelial properties in patients with multisystem LCH in a prospective, observational study.

Interventions:Cardiovascular risk factors: arterial blood pressure, lipid profile, mathematical indices of insulin resistance (IR), intima media thickness, brachial artery flow mediated dilatation, dynamic indices of IR, pituitary function and C-reactive protein will be estimated in patients with LCH and in a control group matched for gender, age, BMI and smoking habits.


Condition
Histiocytosis, Langerhans-Cell

Study Type: Observational
Study Design: Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: CARDIOVASCULAR RISK FACTORS IN ADULT PATIENTS WITH MULTISYSTEM LANGERHANS-CELL HISTIOCYTOSIS: EVIDENCE OF GLUCOSE METABOLISM ABNORMALITIES

Resource links provided by NLM:


Further study details as provided by Laikon General District Hospital, Athens:

Study Start Date: September 2005
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diagnostic criteria for “definitive diagnosis” of LCH

Exclusion Criteria:

  • not participate in strenuous physical activities, on a balanced isocaloric diet for at least 4 weeks prior to the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483925


Contacts
Contact: Gregory Kaltsas, MD, FRCP 00302107462657 gkaltsas@endo.gr

Locations
Greece
Division of Endocrinology, Department of Pathophysiology, Laiko University Hospital, Recruiting
Athens, Greece, 11527
Contact: Gregory Kaltsas, MD, FRCP         
Principal Investigator: Krystallenia I Alexandraki, MD, MSc, PhD         
Sponsors and Collaborators
Laikon General District Hospital, Athens
Investigators
Study Director: Gregory Kaltsas, MD, FRCP Division of Endocrinology, Department of Pathophysiology, Laiko University Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00483925     History of Changes
Other Study ID Numbers: ES 511
First Submitted: June 6, 2007
First Posted: June 8, 2007
Last Update Posted: June 8, 2007
Last Verified: June 2007

Keywords provided by Laikon General District Hospital, Athens:
Langerhans cell histiocytosis
flow mediated dilatation
intima media thickness
insulin resistance
hypopituitarism
glucose and lipid metabolism,
structural arterial and functional endothelial properties in patients with multisystem LCH

Additional relevant MeSH terms:
Histiocytosis
Histiocytosis, Langerhans-Cell
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases