Acromegaly
Conditions
Interventions
Trade Name: Somatuline Autogel
Product Name: Somatuline Autogel
Pharmaceutical Form: Injection
INN or Proposed INN: lanreotide acetate
CAS Number: 127984-74-1
Other descriptive name: LANREOTIDE ACETAT
Sponsors
Medizinische Universität Wien, KIMIII, Abteilung für Endokrinologie und Stoffwechsel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: + (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): lipid content in liver and skeletal muscle, as assessed by 1H magnetic resonance spectroscopy 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 | — |
Countries
Austria
Contacts
Public ContactSekretariat, Endokrinologie
Medizinische Universität Wien, KIM III, Abteilung für Endokrinologie und Stoffwechsel
Outcome results
None listed