Assessment of changes in energy metabolism in liver and skeletal muscle in patients suffering from acromegaly by magnetic resonance spectroscopy
- Conditions
- AcromegalyTherapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2013-004782-14-AT
- Lead Sponsor
- Medizinische Universität Wien, KIMIII, Abteilung für Endokrinologie und Stoffwechsel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patients suffering from Acromegaly:
The diagnosis of acromegaly will be established by GH levels, not suppressible below 1 ng/ml after 75 g oral glucose tolerance test, and by high plasma IGF-I levels for age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4
+ (known) overt diabetes mellitus
+ known coronary artery disease (history of myocardial infarction or angina pectoris)
+ acute or chronic (inflammatory, metabolic [hyperlipidemia, arterial hypertension, thyroid disorder]) disease (healthy controls)
+ intake of medication potentially affecting glucose or lipid metabolism
+ metal devices or other magnetic material in or on the subjects body which will be hazardous for NMR investigation [heart pacemaker, brain (aneurysm) clip, nerve stimulators, electrodes, ear implants, post coronary by-pass graft (epicardial pace wires), penile implants, colored contact lenses, patch to deliver medications through the skin, coiled spring intrauterine device, vascular filter for blood clots, orthodontic braces, shunt- spinal or ventricular, any metal implants (rods, joints, plates, pins, screws, nails, or clips without MR-authorization), embolization coil, or any metal fragments or shrapnel in the body].
+ tendency toward claustrophobia
+ severe liver disorders (plasma transaminases elevated > 3fold)
+ any acute inflammatory disease within 2 weeks prior the study
+ pregnancy
+ Clinically relevant anemia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assessment of metabolic activity in skeletal muscle and liver in patients suffering from acromegaly compared to controls before, as well as in follow up examinations after initiation of therapy (operation, GH lowering drugs);Secondary Objective: Assessment intracellular lipid content in skeletal muscle and liver in patients suffering from acromegaly compared to controls before, as well as in follow up examinations after initiation of therapy (operation, GH lowering drugs);Primary end point(s): metabolic activity in liver and skeletal muscle, as assessed by 31P magnetic resonance spectroscopy saturation transfer;Timepoint(s) of evaluation of this end point: baseline, as well as 3, 6, 9 and 12 months after initiation of therapy, according to current guidelines
- Secondary Outcome Measures
Name Time Method Secondary end point(s): lipid content in liver and skeletal muscle, as assessed by 1H magnetic resonance spectroscopy<br><br>parameters of insulin sensitivity/resistance pre and post treatment;Timepoint(s) of evaluation of this end point: baseline, as well as 3, 6, 9 and 12 months after the initiation of therapy