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Completed

NCT Number: NCT01723748

Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects

The treatment with SA still leaves some questions unanswered. Firstly, SA treatment often results in a concomitant suppression of the insulin secretion, which might lead to clinically significant glucose intolerance. Secondly, the traditional evaluation of disease activity by measuring circulating levels of GH and total IGF-I is not reliable enough

Hypotheses: Treatment of acromegaly with SA versus surgery alone is associated with:

* Glucose intolerance despite normalized insulin sensitivity * Modified peripheral GH activity in peripheral target organs assessed on molecular endpoints

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

Acromegaly is a rare disease usually caused by a benign growth hormone (GH) producing pituitary adenoma. In case of inadequate disease control, the condition is associated with significant morbidity and approximately a doubling of mortality compared to the background population. Medical treatment with somatostatin analogues (SA) has been employed for about 20 years and is a well-established treatment in cases where surgery is impossible or inadequate. The treatment with SA still leaves some questions unanswered. Firstly, SA treatment often results in a concomitant suppression of the insulin secretion, which might lead to clinically significant glucose intolerance. Secondly, the traditional evaluation of disease activity by measuring circulating levels of GH and total IGF-I is not reliable enough

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18 years
  • treated acromegaly
  • considered suitable

Exclusion criteria

  • pregnancy

Treatment and study plan

Genotropin

Drug

iii) intravenous exogenous bolus of GH (0.5 mg) followed by muscle and fat biopsies.

Other names: growth hormone

Primary outcomes

  1. Metabolism - including GH, IGF-I, FFA, glc and insulin. Concentration and AUC (area under the curve)

    Time frame: 3 years

    GH (ug/l), IGF-I (ug/l), FFA (mmol/l) , glc (mmol/l) and insulin (pmol/l)

Secondary outcomes

  1. concentration of serum and interstitial GH, bioactive IGF-I as well as total IGF-I

    Time frame: 3 years

    GH (ug/l), IGF-l (ug/l), bioactive IGF-l (ug/l)

Other outcomes

  1. GH, and insulin signal transduction in muscle and fat biopsies and regulation of lipolysis.

    Time frame: 3 years

    By western blot technique protien levels of (arbitrary densitomety units) AKT, pAKT threonin, pAKT serine, STAT5, pSTAT5, PTEN, p85alpha, mTOR, pmTOR.

    By PCR technique (relative nRNA expression) mRNA levels of IGF-1, SOCS1, SOCS2, SOCS3, CISH, PTEN, Pik3r

  2. patient characterization

    Time frame: 3 years

    sex (M/F), age (year), disease duration (years), BMI (kg/m2)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 8, 2012
Registry last updated
Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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