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Cardiovascular Risk Factors and LCH in Adults

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Laikon General District Hospital, Athens.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Laikon General District Hospital, Athens
ClinicalTrials.gov Identifier:
NCT00483925
First received: June 6, 2007
Last updated: June 7, 2007
Last verified: June 2007
History of Changes
  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:

U.S. FDA Resources

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

Study Start Date: September 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 6, 2007
Last Updated: June 7, 2007
Health Authority: Greece: Ethics Committee

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

ClinicalTrials.gov processed this record on June 18, 2013