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Central Hypothyroidism and Cardiovascular Risk

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ClinicalTrials.gov Identifier: NCT01574859
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : April 2, 2013
Sponsor:
Information provided by (Responsible Party):
Ulla Feldt-Rasmussen, Rigshospitalet, Denmark

Study Description
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Brief Summary:
Retrospective trial of 300 patients with pituitary insufficiency treated in Department of Medica Endocrinology, Rigshospitalet, Copenhagen University concerning levothyroxine (T4) replacement and cardiovascular risk factors. The hypothesis is that subtle central hypothyroidism is associated with adverse cardiac risk factors, such as body composition and serum lipids, and that improved T4 replacement will eliminate this increased risk, independently of other pituitary hormone replacements.

Condition or disease Intervention/treatment
Hypopituitarism Other: levothyroxine

Detailed Description:
Retrospective trial of 300 patients with pituitary insufficiency treated in Department of Medical Endocrinology, Rigshospitalet, Copenhagen University concerning levothyroxine (T4) replacement and cardiovascular risk profile. The patient files are recruited among hypopituitary patients treated with growth hormone from the period 1993 to 2008. The trial is a retrospective assessment of data already collected for routine purposes and thus an audit of daily clinical practice. All information on the patients is obtained from the paper and electronic files existing in the department and no new measurements are foreseen.
Study Design
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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Central Hypothyroidism and Cardiovascular Risk Factors
Study Start Date : April 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism

Groups and Cohorts
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Group/Cohort Intervention/treatment
hypopituitarism
group of patients with hypopituitarism
 Other: levothyroxine
titration of T4 according to biochemical values


Outcome Measures
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Primary Outcome Measures :
  1. cholesterol [ Time Frame: March 2002 - March 2013 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients at Rigshospitalet treated for pituitary hypothyroidism in the years 1993 to 2008
Criteria

Inclusion Criteria:

  • All patients with pituitary hypopituitarism

Exclusion Criteria:

  • Unavailability of data
Contacts and Locations
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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): NCT01574859


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Ulla Feldt-Rasmussen, Professor Rigshospitalet, Denmark
More Information
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Responsible Party: Ulla Feldt-Rasmussen, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01574859    
Other Study ID Numbers: T4-CVR-12
T4-CVR-12 ( Other Grant/Funding Number: Rigshospitalet )
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: April 2, 2013
Last Verified: March 2013
Keywords provided by Ulla Feldt-Rasmussen, Rigshospitalet, Denmark:
central hypothyroidism
hypopituitarism
levothyroxine replacement
lipids
body composition
Additional relevant MeSH terms:
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Hypopituitarism
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
Pituitary Diseases
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases