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Central Hypothyroidism and Cardiovascular Risk

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01574859
First Posted: April 10, 2012
Last Update Posted: April 2, 2013
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 (Responsible Party):
Ulla Feldt-Rasmussen, Rigshospitalet, Denmark
  Purpose
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 Intervention
Hypopituitarism Other: levothyroxine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Central Hypothyroidism and Cardiovascular Risk Factors

Resource links provided by NLM:


Further study details as provided by Ulla Feldt-Rasmussen, Rigshospitalet, Denmark:

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

Enrollment: 200
Study Start Date: April 2012
Study Completion Date: March 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
hypopituitarism
group of patients with hypopituitarism
Other: levothyroxine
titration of T4 according to biochemical values

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
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
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Ulla Feldt-Rasmussen, Professor Rigshospitalet, Denmark
  More Information

Responsible Party: Ulla Feldt-Rasmussen, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01574859     History of Changes
Other Study ID Numbers: T4-CVR-12
T4-CVR-12 ( Other Grant/Funding Number: Rigshospitalet )
First Submitted: April 7, 2012
First Posted: April 10, 2012
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:
Hypothyroidism
Hypopituitarism
Thyroid Diseases
Endocrine System Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases


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