An interventional study of Hydrocortisone and Placebo in Hypopituitarism, Hydrocortisone and Lipids, sponsored by Insel Gruppe AG, University Hospital Bern. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Treatment
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.
Background
The investigators and others have shown that long-term hydrocortisone replacement therapy at higher doses of hydrocortisone replacement therapy at higher doses of hydrocortisone replacement (as previously recommended) is associated with higher mortality. The pathophysiology for the association of hydrocortisone-replacement dose and mortality remains unclear. A possible underlying mechanism is nonalcoholic fatty liver disease which is more prevalent in patients with hypopituitarism. Patients with non-alcoholic fatty liver disease are at a higher risk for overall-mortality.
It remains to be established whether the insulin resistance, associated with increased intrahepatocellular lipids and increased intramusculoskeletal lipids, is implicated in the pathophysiology of these epidemiological findings.
Interestingly, it has been shown that a reduction of hydrocortisone replacement dose from 20-30mg/d to 10-15mg/d resulted in a loss of body fat and a significant decrease of plasma total cholesterol and triglyceride concentration. The effect of IMCL and IHCL is so far unknown.
Patients with hypopituitarism with hydrocortisone replacement therapy provide a unique disease model to study the short-term effects of previously recommended dose (higher dose) of hydrocortisone versus lower dose of HC replacement therapy on ectopic lipids (IMCL; IHCL) lipids, as well as on subcutaneous and visceral fat mass and on parameters of insulin resistance. Combining MRI and MR-spectroscopy techniques, different fat mass (subcutaneous and visceral) and ectopic lipids can be repeatedly and non-invasively assessed.
Objective
To investigate the impact of today's standard of hydrocortisone dosage (lower) versus previous (higher) hydrocortisone dosage on flexibility and partitioning of ectopic lipid depots after a standardised fat load followed by a short-term aerobic exercise in patients with corticotropic pituitary insufficiency.
Methods
Ectopic lipids are measured by MR-spectroscopy, separate assessment of visceral and subcutaneous fat mass will be performed by MR-imaging, standardized exercise capacity test using spiroergometry. Short-time exercise consists of 2h aerobic cycling at 50% VO2max. Laboratory analysis include lipid profile, free fatty acids, HOMA-Index, hormones.
47 studies on the registry are indexed under Hypopituitarism; 8 are open to participants now.
This study's planned enrollment of 30 is below the median of 38 across 29 interventional studies indexed under Hypopituitarism.
Browse Hypopituitarism studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Established hydrocortisone replacement therapy plus 10mg of hydrocortisone
Drug: Hydrocortisone
Established hydrocortisone replacement therapy plus placebo
Drug: Placebo
Established Hydrocortisone replacement therapy plus Hydrocortisone (10mg/day)
Established Hydrocortisone replacement therapy plus Placebo (0mg Hydrocortisone)
Change from baseline in flexibility of Intramyocellular Lipids (IMCL) Measured in mmol/L
Measured in mmol/L
Time frame: 3 months
Change from baseline in flexibility of Intrahepatocellular Lipids (IHCL) Measured in mmol/L
Measured in mmol/L
Time frame: 3 months
Free Fatty Acids (FFA) availability during exercise before and after additional hydrocortisone/placebo Measured in mmol/L
Measured in mmol/L
Time frame: At baseline, 3 months
Flexibility of ectopic fat stores, defined as difference between intramyocellular/intrahepatocellular lipid concentration before and after exercise, and their possible relation to insulin sensitivity before and after additional hydrocortisone/placebo
Time frame: At baseline, 3 months
Free Fatty Acids (FFA) availability during exercise and the possible relation to insulin sensitivity before and after additional hydrocortisone/placebo Measured in mmol/L
Measured in mmol/L
Time frame: At baseline, 3 months
Effect of exercise on insulin at baseline
Time frame: At baseline
Effect of exercise on insulin at 3 months
Time frame: 3 months
Effect of exercise on catecholamines at baseline
Time frame: At baseline
Effect of exercise on catecholamines at 3 months
Time frame: 3 months
Effect of exercise on growth hormone at baseline
Time frame: At baseline
Effect of exercise on growth hormone at 3 months
Time frame: 3 months
Effect of exercise on cortisol at baseline
Time frame: At baseline
Effect of exercise on cortisol at 3 months
Time frame: 3 months
Effect of exercise on lactate at baseline
Time frame: At baseline
Effect of exercise on lactate at 3 months
Time frame: 3 months
Effect of exercise on glucose at baseline
Time frame: At baseline
Effect of exercise on glucose at 3 months
Time frame: 3 months
Effect of exercise on inflammatory markers at baseline
Time frame: At baseline
Effect of exercise on inflammatory markers at 3 months
Time frame: 3 months
This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydrocortisone
Insel Gruppe AG, University Hospital Bern →