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NCT01574859 Clinical Trial

Central Hypothyroidism and Cardiovascular Risk

Hypopituitarism Clinical Trial

Official title:
Central Hypothyroidism and Cardiovascular Risk Factors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01574859
Other study ID # T4-CVR-12
Secondary ID T4-CVR-12
Status Completed
Phase N/A
First received April 7, 2012
Last updated March 30, 2013
Start date April 2012
Est. completion date March 2013

Study information
Verified date March 2013
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date March 2013
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients with pituitary hypopituitarism

Exclusion Criteria:

- Unavailability of data

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• levothyroxine
titration of T4 according to biochemical values

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary cholesterol March 2002 - March 2013 No
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