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
Protocol serial number	LREC/02/01/027
Sponsor	Hull and East Yorkshire Hospitals NHS Trust (UK)
Funder	Eli Lilly (UK) - unrestricted grant

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

Primary study design	Interventional
Study design	Single-centre randomised double-blind placebo-controlled cross-over study
Secondary study design	Randomised cross over trial
Study type	Participant information sheet
Scientific title	Correlation 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 acronym	CAMPING study
Study objectives	Patients 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) studied	Adult growth hormone deficiency
Intervention	Cross-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 type	Biological/Vaccine
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	1. 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.
Key secondary outcome measure(s)	1. 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.
Completion date	01/01/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	20
Total final enrolment	17
Key inclusion criteria	1. 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 criteria	1. Inability to self-administer growth hormone 2. Patients not wishing for their GP to be informed
Date of first enrolment	01/07/2003
Date of final enrolment	01/01/2005

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Hull York Medical School

Hull
HU3 2RW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.