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Central Hypothyroidism and Cardiovascular Risk

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulla Feldt-Rasmussen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01574859
First received: April 7, 2012
Last updated: March 30, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • cholesterol [ Time Frame: March 2002 - March 2013 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574859

Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Ulla Feldt-Rasmussen, Professor Rigshospitalet, Denmark
  More Information

No publications provided

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
Study First Received: April 7, 2012
Last Updated: March 30, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
central hypothyroidism
hypopituitarism
levothyroxine replacement
lipids
body composition

Additional relevant MeSH terms:
Hypopituitarism
Hypothyroidism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on May 16, 2013