Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01723748
First received: November 6, 2012
Last updated: April 4, 2016
Last verified: December 2014
  Purpose

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

Condition Intervention
Acromegaly
Metabolic Diseases
Drug: genotropin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Metabolism - including GH, IGF-I, FFA, glc and insulin. Concentration and AUC (area under the curve) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    GH (ug/l), IGF-I (ug/l), FFA (mmol/l) , glc (mmol/l) and insulin (pmol/l)


Secondary Outcome Measures:
  • concentration of serum and interstitial GH, bioactive IGF-I as well as total IGF-I [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    GH (ug/l), IGF-l (ug/l), bioactive IGF-l (ug/l)


Other Outcome Measures:
  • GH, and insulin signal transduction in muscle and fat biopsies and regulation of lipolysis. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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


  • patient characterization [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    sex (M/F), age (year), disease duration (years), BMI (kg/m2)


Enrollment: 18
Study Start Date: December 2012
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: surgery treated

10 patients with well-controlled acromegaly for at least 6 months after surgery alone.

Stimulated with genotropin

Drug: genotropin
iii) intravenous exogenous bolus of GH (0.5 mg) followed by muscle and fat biopsies.
Other Name: growth hormone
Active Comparator: SA treated
10 patients with well-controlled acromegaly for at least 6 months after SA treatment Stimulated with genotropin
Drug: genotropin
iii) intravenous exogenous bolus of GH (0.5 mg) followed by muscle and fat biopsies.
Other Name: growth hormone

Detailed Description:
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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • > 18 years
  • treated acromegaly
  • considered suitable

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723748

Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Jens Otto L Joergensen, professor Aarhus University Hospital
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01723748     History of Changes
Other Study ID Numbers: 1-10-72-491-12  35197 
Study First Received: November 6, 2012
Last Updated: April 4, 2016
Health Authority: Denmark: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Aarhus:
Acromegaly
Somatostatin treatment
metabolic effect

Additional relevant MeSH terms:
Acromegaly
Metabolic Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 22, 2016