Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/02/2009
Date assigned
16/02/2009
Last edited
29/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen Atkin

ORCID ID

Contact details

Head of Academic Endocrinology
Diabetes and Metabolism
Hull York Medical School
Michael White Diabetes Centre
220 - 236 Anlaby Road
Hull
HU3 2RW
United Kingdom

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 measures

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

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

http://www.hey.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes