TerminatedNot Applicable

The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids in Patients With Corticotropic Hypopituitarism

Switzerland30 participantsStarted 2015-01

Plain-language summary

This study aims at assessing the effect of today's standard of hydrocortisone dosage versus previous hydrocortisone dosage on flexibility and partitioning of ectopic lipid depots (IMCL and IHCL) after a standardised fat load followed by a short-term aerobic exercise in patients with corticotropic pituitary insufficiency.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent * Male and female patients * Corticotropic pituitary insufficiency * Capable to exercise during 120 minutes on a bicycle * Normal ECG during ergometry Exclusion Criteria * Concomitant medication with NSAID, anticoagulants, digoxin, salbutamol, anticonvulsants, cholinesterase inhibitor, pancuronium * Abnormal liver, renal or thyroid function, heart failure * Hemophilia * Diabetes mellitus * Severe dyslipidemia * Active neoplasia * Women who are pregnant or breast feeding * Intention to become pregnant during the course of the study * Lack of safe contraception * Known or suspected non-compliance * Drug or alcohol abuse * Inability to follow the procedures of the study * Participation in another study with investigational drug within the 30 days preceding and during the study * Previous enrolment into current study * Enrolment of the investigator, his/her family members, employees and other dependent persons * Inability to exercise * Contraindications to exposure to a 3 T magnetic field * Major depression, psychosis, claustrophobia

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in flexibility of Intramyocellular Lipids (IMCL) Measured in mmol/L

Timeframe: 3 months

Change from baseline in flexibility of Intrahepatocellular Lipids (IHCL) Measured in mmol/L

Timeframe: 3 months

Trial details

NCT IDNCT02360046

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12

View on ClinicalTrials.gov More Hypopituitarism trials