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Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects

This study is not yet open for participant recruitment.
Verified November 2012 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01723748
First received: November 6, 2012
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

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

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
Somatostatin
Metabolism
Signal Transduction
 Drug: GH

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:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • glucose tolerance, including AUC (area under the curve)insulin [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • concentration of interstitial bioactive IGF-I as well as total IGF-I, IGFBP and insulin [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: surgery treated
15 patients with well-controlled acromegaly for at least 6 months after surgery alone
 Drug: GH
iii) intravenous exogenous bolus of GH (0.5 mg) followed by muscle and fat biopsies.
Active Comparator: SA treated
15 patients with well-controlled acromegaly for at least 6 months after SA treatment
 Drug: GH
iii) intravenous exogenous bolus of GH (0.5 mg) followed by muscle and fat biopsies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • > 18 years
  • treated acromegaly
  • considered suitable

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01723748

Contacts
Contact: Jakob Dal, phd student +45 61394231 jakob.dal@dadlnet.dk

Locations
Denmark
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark, 8000
Contact: Jakob Dal, phd student     +45 61394231     jakob.dal@dadlnet.dk    
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Jens Otto L Joergensen, prof. dr. med. Aarhus University Hospital
  More Information

No publications provided

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: November 14, 2012
Health Authority: Denmark: Ethics Committee

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

Additional relevant MeSH terms:
Acromegaly
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013