Correlation of cardiac function indices and peripheral muscle mitochondrial changes in patients with severe adult growth hormone deficiency following growth hormone therapy

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN94165486

Enrollment

Registered

2009-02-16

Start date

2003-07-01

Completion date

Unknown

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult growth hormone deficiency Nutritional, Metabolic, Endocrine Hypofunction and other disorders of pituitary gland

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Inability to self-administer growth hormone 2. Patients not wishing for their GP to be informed

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026