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Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects

University of Aarhus logo

University of Aarhus

Status

Completed

Conditions

Metabolic Diseases
Acromegaly

Treatments

Drug: genotropin

Study type

Interventional

Funder types

Other

Identifiers

NCT01723748
1-10-72-491-12
35197 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • > 18 years
  • treated acromegaly
  • considered suitable

Exclusion criteria

  • pregnancy

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

18 participants in 2 patient groups

surgery treated
Active Comparator group
Description:
10 patients with well-controlled acromegaly for at least 6 months after surgery alone. Stimulated with genotropin
Treatment:
Drug: genotropin
SA treated
Active Comparator group
Description:
10 patients with well-controlled acromegaly for at least 6 months after SA treatment Stimulated with genotropin
Treatment:
Drug: genotropin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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