Correlation of cardiac function indices and peripheral muscle mitochondrial changes in patients with severe adult growth hormone deficiency following growth hormone therapy
Not Applicable
Completed
- Conditions
- Adult growth hormone deficiencyNutritional, Metabolic, EndocrineHypofunction and other disorders of pituitary gland
- Registration Number
- ISRCTN94165486
- Lead Sponsor
- Hull and East Yorkshire Hospitals NHS Trust (UK)
- Brief Summary
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29527190 (added 27/06/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 17
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
Exclusion Criteria
1. Inability to self-administer growth hormone
2. Patients not wishing for their GP to be informed
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Modification of mitochondrial function in vitro: needle muscle biopsy for measurement of mitochondrial function<br> 2. Modification of cardiovascular function:<br> 2.1. Echocardiogram for wall thickness ejection fraction, fraction with shortening of stroke distance<br> 2.2. Magnetic resonance imaging (MRI) for wall thickness, muscle mass, ventricular volumes and ejection fraction<br> 2.3. Exercise testing, six minute walk, metabolic gas exchange to derive peak VO2 and the ventilatory response to exercise<br> 2.4. Muscle strength<br><br> Measured at baseline, 3 months, 6 months, 9 months and 12 months.<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Blood will be withdrawn for cardiovascular risk indices including:<br> 1.1. Fasting sample for homocysteine, urate, low level C-reactive protein, triglycerides, low density lipoprotein (LDL), high density lipoprotein (HDL)<br> 1.2. Plasminogen activator inhibitor-1 (PAI 1), fibrinogen, factor 7 and 12<br> 1.3. Fasting insulin glucose to determine insulin resistance by the homeostasis model assessment (HOMA) method<br> 1.4. Lipid peroxides<br> 2. Insulin-like Growth Factor-1 (IGF1) levels<br> 3. Percentage of body fat (using bioimpedance technique), waist-hip ratio, blood pressure, weight<br><br> Measured at baseline, 3 months, 6 months, 9 months and 12 months.<br>