NCT00483925

Brief Summary

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.

Trial Health

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Trial Health Score

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Geographic Reach
1 country

1 active site

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2007

Completed
Last Updated

June 8, 2007

Status Verified

June 1, 2007

First QC Date

June 6, 2007

Last Update Submit

June 7, 2007

Conditions

Keywords

Langerhans cell histiocytosisflow mediated dilatationintima media thicknessinsulin resistancehypopituitarismglucose and lipid metabolism,structural arterial and functional endothelial properties in patients with multisystem LCH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnostic criteria for "definitive diagnosis" of LCH

You may not qualify if:

  • not participate in strenuous physical activities, on a balanced isocaloric diet for at least 4 weeks prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Endocrinology, Department of Pathophysiology, Laiko University Hospital,

Athens, 11527, Greece

RECRUITING

Related Publications (3)

  • 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. doi: 10.14310/horm.2002.11176.

    PMID: 16807225BACKGROUND
  • 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. doi: 10.1007/s00234-005-0011-x. Epub 2005 Nov 15.

    PMID: 16292545BACKGROUND
  • 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. doi: 10.1016/s0959-8049(03)00672-5.

MeSH Terms

Conditions

Histiocytosis, Langerhans-CellInsulin ResistanceHypopituitarism

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesHistiocytosisLymphatic DiseasesHemic and Lymphatic DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Gregory Kaltsas, MD, FRCP

    Division of Endocrinology, Department of Pathophysiology, Laiko University Hospital

    STUDY DIRECTOR

Central Study Contacts

Gregory Kaltsas, MD, FRCP

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2007

First Posted

June 8, 2007

Study Start

September 1, 2005

Last Updated

June 8, 2007

Record last verified: 2007-06

Locations