Assessment of Changes in Metabolic Activity in Liver & Skeletal Muscle in Patients Suffering From Acromegaly

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Assessment of Changes in Metabolic Activity in Liver & Skeletal Muscle in Patients Suffering From Acromegaly

Official Title

Assessment of Changes in Metabolic Activity in Liver & Skeletal Muscle in Patients Suffering From Acromegaly - a 31P/1H Magnetic Resonance Spectroscopy Pilot Study

Brief Summary

      Growth hormone (GH) plays a pivotal role in the regulation of body composition including
      ectopic lipid deposition in insulin sensitive organs like liver and skeletal muscle. Recent
      evidence indicates that the GH-IGF1 axis affects body composition via regulating
      mitochondrial oxidation capacity.

      Thus, excessive GH secretion by a pituitary adenoma (Acromegaly) might be accompanied by
      increased mitochondrial activity leading to inappropriately low intracellular lipid depots,
      especially in metabolically active tissue like liver and skeletal muscle.

      This study aims to assess metabolic activity and intracellular lipid content in skeletal
      muscle and liver in patients suffering from acromegaly compared to controls by 31P/1H
      Magnetic resonance spectroscopy before and in follow up examinations 3, 6 and 12 months after
      initiation of GH lowering treatments including surgery, somatostatinanalogs or pegvisomant,
      as well as oral glucose tolerance tests at each examination to assess treatment responses and
      calculate validated parameters for insulin sensitivity and resistance.

Detailed Description

      Background: Growth hormone (GH) plays a pivotal role in the regulation of body composition
      including ectopic lipid deposition in insulin sensitive organs like liver and skeletal
      muscle. Direct inhibition of growth hormone action by a receptor antagonist has been shown to
      induce hepatic steatosis and growth hormone replacement decreases liver fat content in obese
      humans. Of note, recent evidence indicates that the GH-IGF1 axis affects body composition via
      regulating mitochondrial oxidation capacity.

      Hypothesis: Direct and/or indirect effects of GH on mitochondrial function might mediate the
      changes in body composition and lipid deposition. Thus, excessive GH secretion by a pituitary
      adenoma (Acromegaly) might be accompanied by increased mitochondrial activity leading to
      inappropriately low intracellular lipid depots, especially in metabolically active tissue
      like liver and skeletal muscle.

      Aim: Assessment of metabolic activity and intracellular lipid content in skeletal muscle and
      liver in patients suffering from acromegaly compared to controls.

      Methods: Non-interventional study:

        -  31P/1H Magnetic resonance spectroscopy before and in follow up examinations 3, 6 and 12
           months after initiation of GH lowering treatments including surgery, somatostatinanalogs
           or pegvisomant.

        -  oral glucose tolerance tests at each examination to assess treatment responses and
           calculate validated parameters for insulin sensitivity and resistance.

Study Type

Observational

Primary Outcome

Changes in hepatic energy metabolism

Secondary Outcome

 Changes in hepatic lipid content

Condition

Acromegaly

Intervention

1H/31P Magnetic Resonance Spectroscopy

Study Arms / Comparison Groups

 Acromegalic patients
Description:  Acromegalic patients before and after initiation of individual therapy will be investigated by 1H/31P magnetic resonance spectroscopy, thyroid sonography and oral glucose tolerance testing

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

24

Start Date

August 2014

Completion Date

May 2018

Primary Completion Date

May 2017

Eligibility Criteria

        Inclusion Criteria:

          -  age between 18-75 years

        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

          -  nursing

          -  clinically relevant anemia

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Michael Krebs, MD, Prof., 00431404004311, [email protected]

Location Countries

Austria

Location Countries

Austria

Administrative Informations

NCT ID

NCT02115906

Organization ID

THIGHT_2

Responsible Party

Principal Investigator

Study Sponsor

Medical University of Vienna

Study Sponsor

Michael Krebs, MD, Prof., Principal Investigator, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria

Verification Date

September 2016