Central Hypothyroidism and Cardiovascular Risk

March 30, 2013 updated by: Ulla Feldt-Rasmussen, Rigshospitalet, Denmark

Central Hypothyroidism and Cardiovascular Risk Factors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients at Rigshospitalet treated for pituitary hypothyroidism in the years 1993 to 2008

Description

Inclusion Criteria:

  • All patients with pituitary hypopituitarism

Exclusion Criteria:

  • Unavailability of data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hypopituitarism
group of patients with hypopituitarism
Other: levothyroxine
titration of T4 according to biochemical values

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cholesterol
Time Frame: March 2002 - March 2013
March 2002 - March 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

April 7, 2012

First Submitted That Met QC Criteria

April 9, 2012

First Posted (ESTIMATE)

April 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 2, 2013

Last Update Submitted That Met QC Criteria

March 30, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T4-CVR-12 (OTHER_GRANT: Rigshospitalet)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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