Status:
COMPLETED
Cardiac and Skeletal Muscle Energy Metabolism in Abnormal Growth Hormone States
Lead Sponsor:
Barts & The London NHS Trust
Conditions:
Acromegaly
Growth Hormone Deficiency
Eligibility:
All Genders
18-75 years
Brief Summary
Growth hormone (GH) is important for growth in childhood, but also has important effects on a number of tissues throughout life. GH deficiency and GH excess (acromegaly, caused by a pituitary tumour) ...
Detailed Description
INTRODUCTION The effect of GH and IGF-I on the heart has been demonstrated in numerous experimental studies. GH and IGF-I receptors are expressed in cardiac myocytes, and IGF-I causes hypertrophy of c...
Eligibility Criteria
Inclusion
- for acromegaly
- Clinical and biochemical diagnosis of acromegaly. Thyroid and glucocorticoid replacement if necessary stable for at least 4 weeks before the study. Gonadotrophin status will be recorded and whenever possible patients will be studied in the same status
- Males and females aged 18-70 years willing to give informed consent
- At least 6 months after the onset of symptoms of acromegaly and on stable medication for heart failure treatment (if any) for at least 4 weeks prior to inclusion into the study
- Systolic blood pressure \< 180 mmHg, diastolic blood pressure \< 110 mmHg.
- for GHD
- Clinical and biochemical diagnosis of GHD. All hormones replaced (if clinically necessary) except GH. Thyroid and glucocorticoid replacement if necessary stable for at least 4 weeks before the study. Gonadotrophin status will be recorded and whenever possible patients will be studied in the same status
- Males and females aged 18-70 years willing to give informed consent
- At least 6 months after the onset of symptoms of acromegaly and on stable medication for heart failure treatment (if any) for at least 4 weeks prior to inclusion into the study
- Systolic blood pressure \< 180 mmHg, diastolic blood pressure \< 110 mmHg.
Exclusion
- for acromegaly
- Change in medication in the preceding 4 weeks
- Patients on subcutaneous insulin therapy
- Hyperthyroidism
- Not being in sinus rhythm
- Unstable angina pectoris and decompensated heart failure (define as NYHA 3-4)
- Clinically significant valvular disease, clinically significant chronic obstructive pulmonary disease
- History of myocardial infarction or stroke within the last 6 months, major cardiac surgery within the last 6 months
- Significant history of drug- or alcohol abuse or unable to give informed consent
- Any other significant surgical or medical condition which would considerably affect results in view of the identifying clinician
- Typical contraindication for MR (e.g. metal implants in delicate positions, aneurysm clips, shrapnel injuries, pacemakers, internal defibrillators and severe claustrophobia)
- Pregnancy
- for GHD
- Change in medication in the preceding 4 weeks
- Previous history of acromegaly
- Child-hood onset GHD
- Patients on subcutaneous insulin therapy metformin probably an exclusion
- Hyperthyroidism
- Not being in sinus rhythm
- Unstable angina pectoris and decompensated heart failure (define as NYHA 3-4)
- Clinically significant valvular disease, clinically significant chronic obstructive pulmonary disease
- History of myocardial infarction or stroke within the last 6 months, major cardiac surgery within the last 6 months?
- Significant history of drug- or alcohol abuse or unable to give informed consent
- Any other significant surgical or medical condition which would considerably affect results in view of the identifying clinician
- Typical contraindication for MR (e.g. metal implants in delicate positions, aneurysm clips, shrapnel injuries, pacemakers, internal defibrillators and severe claustrophobia)
- Pregnancy
Key Trial Info
Start Date :
June 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00461240
Start Date
June 1 2007
End Date
December 1 2011
Last Update
July 26 2012
Active Locations (1)
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1
St Bartholomew's Hospital
West Smithfield, London, United Kingdom, EC1A 7BE