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| Correlation of cardiac function indices and peripheral muscle mitochondrial changes in patients with severe adult growth hormone deficiency following growth hormone therapy |
| ISRCTN | ISRCTN94165486 |
| ClinicalTrials.gov identifier | |
| Public title | Correlation of cardiac function indices and peripheral muscle mitochondrial changes in patients with severe adult growth hormone deficiency following growth hormone therapy |
| 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 |
| Serial number at source | LREC/02/01/027 |
| 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. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Hull and East Yorkshire LREC gave approval on the 17th June 2002 (ref: LREC/02/01/027) |
| Study design | Single centre randomised double blind placebo controlled cross-over study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Adult growth hormone deficiency |
| Participants - 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 |
| Participants - exclusion criteria |
1. Inability to self-administer growth hormone
2. Patients not wishing for their GP to be informed |
| Anticipated start date | 01/07/2003 |
| Anticipated end date | 01/01/2005 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 20 patients |
| Interventions |
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. |
| 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. |
| 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. |
| Sources of funding | Eli Lilly (UK) - unrestricted grant |
| Trial website | |
| Publications | |
| Contact name | Prof Stephen Atkin |
| Address |
Head of Academic Endocrinology, Diabetes and Metabolism
Hull York Medical School Michael White Diabetes Centre 220 - 236 Anlaby Road |
| City/town | Hull |
| Zip/Postcode | HU3 2RW |
| Country | United Kingdom |
| Sponsor | Hull and East Yorkshire Hospitals NHS Trust (UK) |
| Address | 220 - 236 Anlaby Road |
| City/town | Hull |
| Zip/Postcode | HU3 2RW |
| Country | United Kingdom |
| Sponsor website: | http://www.hey.nhs.uk/ |
| Date applied | 10/02/2009 |
| Last edited | 14/11/2011 |
| Date ISRCTN assigned | 16/02/2009 |
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