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Central Hypothyroidism and Cardiovascular Risk

NCT ID: NCT01574859

Last Updated: 2013-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypopituitarism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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hypopituitarism

group of patients with hypopituitarism

levothyroxine

Intervention Type OTHER

titration of T4 according to biochemical values

Interventions

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levothyroxine

titration of T4 according to biochemical values

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients with pituitary hypopituitarism

Exclusion Criteria

* Unavailability of data
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Ulla Feldt-Rasmussen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulla Feldt-Rasmussen, Professor

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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T4-CVR-12

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

T4-CVR-12

Identifier Type: -

Identifier Source: org_study_id

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