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

NCT02360046 | Terminated

• 2 other identifiers: 211/142014 DR 4137
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypopituitarism; Hydrocortisone; Lipids; Fatty Acids, Nonesterified; Insulin Sensitivity

Outcome Measures

Primary Outcomes (2)

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

  Measured in mmol/L

  3 months

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

  Measured in mmol/L

  3 months

Secondary Outcomes (17)

• Free Fatty Acids (FFA) availability during exercise before and after additional hydrocortisone/placebo Measured in mmol/L

  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

  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

  At baseline, 3 months

• Effect of exercise on insulin at baseline

  At baseline

• Effect of exercise on insulin at 3 months

  3 months

Study Arms (2)

Higher hydrocortisone dose

OTHER

Established hydrocortisone replacement therapy plus 10mg of hydrocortisone

Drug: Hydrocortisone

Lower hydrocortisone dose

OTHER

Established hydrocortisone replacement therapy plus placebo

Drug: Placebo

Interventions

Hydrocortisone DRUG

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

Higher hydrocortisone dose

Placebo DRUG

Established Hydrocortisone replacement therapy plus Placebo (0mg Hydrocortisone)

Lower hydrocortisone dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Male and female patients
• Corticotropic pituitary insufficiency
• Capable to exercise during 120 minutes on a bicycle
• Normal ECG during ergometry

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Berne

Bern, 3010, Switzerland

Location

Related Publications (2)

• Boesch C, Slotboom J, Hoppeler H, Kreis R. In vivo determination of intra-myocellular lipids in human muscle by means of localized 1H-MR-spectroscopy. Magn Reson Med. 1997 Apr;37(4):484-93. doi: 10.1002/mrm.1910370403.

  PMID: 9094069 BACKGROUND

• Danilowicz K, Bruno OD, Manavela M, Gomez RM, Barkan A. Correction of cortisol overreplacement ameliorates morbidities in patients with hypopituitarism: a pilot study. Pituitary. 2008;11(3):279-85. doi: 10.1007/s11102-008-0126-2.

  PMID: 18459045 BACKGROUND

MeSH Terms

Conditions

Hypopituitarism; Insulin Resistance

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Emanuel Christ, MD, PhD

  Division of Endocrinology, Diabetes and Clinical Nutrition, University Hospital Bern

  PRINCIPAL INVESTIGATOR

• Chris Boesch, MD, PhD

  AMSM; Division of Radiology, University Hopsital of Bern, Inselspital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: February 10, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

CH (1)