Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LREC/02/01/027
Study information
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
Acronym
CAMPING study
Study hypothesis
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
Hull and East Yorkshire LREC, 17/06/2002, ref: LREC/02/01/027
Study design
Single-centre randomised double-blind placebo-controlled cross-over study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Primary outcome measure
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.
Secondary outcome measures
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.
Overall trial start date
01/07/2003
Overall trial end date
01/01/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20 patients
Participant exclusion criteria
1. Inability to self-administer growth hormone
2. Patients not wishing for their GP to be informed
Recruitment start date
01/07/2003
Recruitment end date
01/01/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hull York Medical School
Hull
HU3 2RW
United Kingdom
Sponsor information
Organisation
Hull and East Yorkshire Hospitals NHS Trust (UK)
Sponsor details
220 - 236 Anlaby Road
Hull
HU3 2RW
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Eli Lilly (UK) - unrestricted grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list