Cardiovascular Risk Factors and LCH in Adults - Full Text View

Sponsored by:	Laikon General District Hospital, Athens
Information provided by:	Laikon General District Hospital, Athens
ClinicalTrials.gov Identifier:	NCT00483925

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

Drug Information available for: Insulin Dextrose Lipids

U.S. FDA Resources

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

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 of Results:

Arico M, Girschikofsky M, Genereau T, Klersy C, McClain K, Grois N, Emile JF, Lukina E, De Juli E, Danesino C. Langerhans cell histiocytosis in adults. Report from the International Registry of the Histiocyte Society. Eur J Cancer. 2003 Nov;39(16):2341-8.

Other Publications:

Alexandraki K, Protogerou AD, Papaioannou TG, Piperi C, Mastorakos G, Lekakis J, Panidis D, Diamanti-Kandarakis E. Early microvascular and macrovascular dysfunction is not accompanied by structural arterial injury in polycystic ovary syndrome. Hormones (Athens). 2006 Apr-Jun;5(2):126-36.

Makras P, Samara C, Antoniou M, Zetos A, Papadogias D, Nikolakopoulou Z, Andreakos E, Toloumis G, Kontogeorgos G, Piaditis G, Kaltsas GA. Evolving radiological features of hypothalamo-pituitary lesions in adult patients with Langerhans cell histiocytosis (LCH). Neuroradiology. 2006 Jan;48(1):37-44. Epub 2005 Nov 15.

Study ID Numbers:	ES 511
Study First Received:	June 6, 2007
Last Updated:	June 7, 2007
ClinicalTrials.gov Identifier:	NCT00483925
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

Study placed in the following topic categories:

Lung Diseases, Interstitial
Dilatation, Pathologic
Langerhans cell histiocytosis
Histiocytosis, Langerhans-Cell
Insulin
Histiocytosis X
Lymphatic Diseases

Letterer-Siwe disease
Hypopituitarism
Histiocytosis
Respiratory Tract Diseases
Lung Diseases
Insulin Resistance
Congenital Abnormalities

Additional relevant MeSH terms:

Reticuloendotheliosis

ClinicalTrials.gov processed this record on January 14, 2009