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
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 |
|---|---|
| James.Illingworth@hey.nhs.uk |
Study information
| Study design | Single-centre randomised double-blind placebo-controlled cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/07/2003 |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 patients |
| 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
- England
- United Kingdom
Study participating centre
Hull York Medical School
Hull
HU3 2RW
United Kingdom
HU3 2RW
United Kingdom
Sponsor information
Hull and East Yorkshire Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
220 - 236 Anlaby Road
Hull
HU3 2RW
England
United Kingdom
| Website | http://www.hey.nhs.uk/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
