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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02360046
• Date of registration: 16/01/2015
• Prospective Registration: No
• Primary sponsor: University Hospital Inselspital, Berne
• Public title: The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids in Patients With Corticotropic Hypopituitarism Hydrocort
• Scientific title: The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids (Intrahepatocellular IHCL and Intramyocellular IMCL) in Patients With Corticotropic Hypopituitarism, a Randomised Placebo-controlled Double-blind Trial
• Date of first enrolment: January 2015
• Target sample size: 30
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02360046
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Emanuel Christ, MD, PhD
• Affiliation: Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern

• Name: Chris Boesch, MD, PhD
• Affiliation: AMSM; Division of Radiology, University Hopsital of Bern, Inselspital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypopituitarism

Fatty Acids, Nonesterified

Insulin Sensitivity

Hydrocortisone

Lipids

Intervention(s)

Drug: Placebo

Drug: Hydrocortisone

Primary Outcome(s)

Change from baseline in flexibility of Intrahepatocellular Lipids (IHCL) Measured in mmol/L [Time Frame: 3 months]

Change from baseline in flexibility of Intramyocellular Lipids (IMCL) Measured in mmol/L [Time Frame: 3 months]

Secondary Outcome(s)

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]

Effect of exercise on glucose at 3 months [Time Frame: 3 months]

Effect of exercise on lactate 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 3 months [Time Frame: 3 months]

Effect of exercise on catecholamines at baseline [Time Frame: At baseline]

Effect of exercise on cortisol at baseline [Time Frame: At baseline]

Effect of exercise on inflammatory markers at baseline [Time Frame: At baseline]

Effect of exercise on insulin at 3 months [Time Frame: 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 [Time Frame: At baseline, 3 months]

Effect of exercise on cortisol at 3 months [Time Frame: 3 months]

Effect of exercise on growth hormone 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 inflammatory markers at 3 months [Time Frame: 3 months]

Free Fatty Acids (FFA) availability during exercise before and after additional hydrocortisone/placebo Measured in mmol/L [Time Frame: At baseline, 3 months]

Effect of exercise on insulin at baseline [Time Frame: At baseline]

Secondary ID(s)

2014 DR 4137

211/14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors