Correlation of cardiac function indices and peripheral muscle mitochondrial changes in patients with severe adult growth hormone deficiency following growth hormone therapy

ISRCTN ISRCTN94165486
DOI https://doi.org/10.1186/ISRCTN94165486
Secondary identifying numbers LREC/02/01/027
Submission date
10/02/2009
Registration date
16/02/2009
Last edited
27/06/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr James Illingworth
Scientific

Research and Development Department
Hull University Teaching Hospitals NHS Trust
Office 14, 2nd Floor Daisy Building
Castle Hill Hospital
Cottingham
HU16 5JQ
United Kingdom

Phone +44 (0)1482 461903
Email James.Illingworth@hey.nhs.uk

Study information

Study designSingle-centre randomised double-blind placebo-controlled cross-over study
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCorrelation of cardiac function indices and peripheral muscle mitochondrial changes in patients with severe adult growth hormone deficiency following growth hormone therapy: a single centre, randomised, double-blind placebo-controlled cross-over study over a six-month period followed by an open-label six-month phase
Study acronymCAMPING study
Study objectivesPatients with severe adult growth hormone deficiency have a twofold increase in cardiovascular death. Tentative evidence suggests that growth hormone therapy has cardiovascular benefits and there are reports of apparent cardiomyopathy being reversible with growth hormone administration. Attempts have been made at using growth hormone as specific therapy in heart failure with variable effects on left ventricular mass, left ventricular size and wall stress. However, there seems to be a consistent improvement in quality of life and increased exercise capacity. Others have assessed growth hormone replacement in adults and suggested there is an improvement in echocardiographic variables.

Studies reporting the effect of physical training on patients with chronic heart failure have shown a significant change in mitochondrial function in those patients in the exercise group. In those studies, the mitochondrial changes were significantly related to changes in oxygen uptake and at the ventilatory threshold. It is proposed that growth hormone treatment may significantly improve mitochondrial function which correlate to cardiac indices, giving a mechanism by which growth hormone may exert a cardioprotective effect.
Ethics approval(s)Hull and East Yorkshire LREC, 17/06/2002, ref: LREC/02/01/027
Health condition(s) or problem(s) studiedAdult growth hormone deficiency
InterventionCross-over phase:
1. Active phase: recombinant growth hormone (rGH, dose = 0.4 mg/day) for 3 months
2. Placebo: sterile diluent containing glycerol and m-cresol or vice versa for 3 months

Patients are then crossed over to receive the alternative treatment. Thereafter, patients continued GH therapy for a further 6 months at same dose.
Intervention typeBiological/Vaccine
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure1. Modification of mitochondrial function in vitro: needle muscle biopsy for measurement of mitochondrial function
2. Modification of cardiovascular function:
2.1. Echocardiogram for wall thickness ejection fraction, fraction with shortening of stroke distance
2.2. Magnetic resonance imaging (MRI) for wall thickness, muscle mass, ventricular volumes and ejection fraction
2.3. Exercise testing, six minute walk, metabolic gas exchange to derive peak VO2 and the ventilatory response to exercise
2.4. Muscle strength

Measured at baseline, 3 months, 6 months, 9 months and 12 months.
Secondary outcome measures1. Blood will be withdrawn for cardiovascular risk indices including:
1.1. Fasting sample for homocysteine, urate, low level C-reactive protein, triglycerides, low density lipoprotein (LDL), high density lipoprotein (HDL)
1.2. Plasminogen activator inhibitor-1 (PAI 1), fibrinogen, factor 7 and 12
1.3. Fasting insulin glucose to determine insulin resistance by the homeostasis model assessment (HOMA) method
1.4. Lipid peroxides
2. Insulin-like Growth Factor-1 (IGF1) levels
3. Percentage of body fat (using bioimpedance technique), waist-hip ratio, blood pressure, weight

Measured at baseline, 3 months, 6 months, 9 months and 12 months.
Overall study start date01/07/2003
Completion date01/01/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20 patients
Total final enrolment17
Key inclusion criteria1. Male or female patients aged between 18 and 75 years of age
2. Proven severe adult growth hormone deficiency by standard criteria
3. Ability to self-administer growth hormone
4. Ability to give informed consent
Key exclusion criteria1. Inability to self-administer growth hormone
2. Patients not wishing for their GP to be informed
Date of first enrolment01/07/2003
Date of final enrolment01/01/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Hull York Medical School
Hull
HU3 2RW
United Kingdom

Sponsor information

Hull and East Yorkshire Hospitals NHS Trust (UK)
Hospital/treatment centre

220 - 236 Anlaby Road
Hull
HU3 2RW
England
United Kingdom

Website http://www.hey.nhs.uk/
ROR logo "ROR" https://ror.org/01b11x021

Funders

Funder type

Industry

Eli Lilly (UK) - unrestricted grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 23/02/2018 27/06/2019 Yes No

Editorial Notes

27/06/2019: Publication reference and total final enrolment added.
13/06/2019: Contact details updated.
19/07/2017: No publications found in PubMed, verifying study status with principal investigator.