ClinicalTrials.gg
CompletedNCT01574859Updated Apr 2, 2013

Central Hypothyroidism and Cardiovascular Risk

An observational study in Hypopituitarism, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2013-04-02.

Sponsored by Rigshospitalet, Denmark · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypopituitarism

Keywords

  • central hypothyroidism
  • hypopituitarism
  • levothyroxine replacement
  • lipids
  • body composition
03

In context

Hypopituitarism

47 studies on the registry are indexed under Hypopituitarism; 8 are open to participants now.

This study's enrollment of 200 is above the median of 137 across 17 observational studies indexed under Hypopituitarism.

Browse Hypopituitarism studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients with pituitary hypopituitarism

Exclusion criteria

Exclusion Criteria:

  • Unavailability of data
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (actual)

Groups and cohorts

  • hypopituitarism

    group of patients with hypopituitarism

    Other: levothyroxine

Interventions

  • Otherlevothyroxine

    titration of T4 according to biochemical values

06

What researchers measure

Primary outcomes

  1. cholesterol

    Time frame: March 2002 - March 2013

07

Study locations

1 site
  • Rigshospitalet
    Copenhagen, 2100, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01574859
Responsible party
Ulla Feldt-Rasmussen (Professor, Rigshospitalet, Denmark) — Principal investigator
First posted
Apr 10, 2012
Start date
Apr 2012
Primary completion
Nov 2012
Completion
Mar 2013
Last update
Apr 2, 2013

Study contacts

Ulla Feldt-Rasmussen, Professor
principal investigator · Rigshospitalet, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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