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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypopituitarism Hydrocortisone Lipids Fatty Acids, Nonesterified Insulin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Higher hydrocortisone dose

Established hydrocortisone replacement therapy plus 10mg of hydrocortisone

Group Type OTHER

Hydrocortisone

Intervention Type DRUG

Established Hydrocortisone replacement therapy plus Hydrocortisone (10mg/day)

Lower hydrocortisone dose

Established hydrocortisone replacement therapy plus placebo

Group Type OTHER

Placebo

Intervention Type DRUG

Established Hydrocortisone replacement therapy plus Placebo (0mg Hydrocortisone)

Interventions

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Hydrocortisone

Established Hydrocortisone replacement therapy plus Hydrocortisone (10mg/day)

Intervention Type DRUG

Placebo

Established Hydrocortisone replacement therapy plus Placebo (0mg Hydrocortisone)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No