Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02871986 - Pubertal Induction in Individuals With Hypogonadism N/A
Completed NCT00851942 - Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test Phase 4
Completed NCT00507104 - Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
Completed NCT01088399 - A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults N/A
Completed NCT00027430 - Androgen Replacement Therapy in Women With Hypopituitarism N/A
Recruiting NCT04897802 - Identification and Clinical Relevance of an Oxytocin Deficient State (GLP1 Study) Phase 4
Not yet recruiting NCT06014398 - Improving Survivorship and Health-related Quality of Life in Patients With Primary Brain Tumours N/A
Recruiting NCT04121780 - Growth Hormone Replacement Therapy for Retried Professional Football Players Phase 2
Not yet recruiting NCT01666964 - Hormone Deficiency After Brain Injury During Combat N/A
Completed NCT01028742 - Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity N/A
Completed NCT00139945 - Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients N/A
Completed NCT05188131 - Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium Phase 4
Completed NCT05206149 - Stimulation Test With Intranasal Glucagon for Corticotroph, Somatotroph and Antidiuretic Axes Phase 4
Completed NCT00133354 - Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys Phase 2/Phase 3
Not yet recruiting NCT03708523 - Next Day Growth Hormone Predicting Pituitary Function After Adenomectomy
Completed NCT01007071 - Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults With Growth Hormone Deficiency Phase 3
Not yet recruiting NCT06326853 - Neuroendocrine Mechanisms in Adiposity: An Integrated Approach to the Characterization of Potential Pharmacological Novel Targets Based on Experimental and Clinical Models
Completed NCT00080483 - Testosterone and Growth Hormone for Bone Loss in Men Phase 2
Completed NCT01009905 - An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone) N/A
Completed NCT01209416 - The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin N/A