Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects

NCT ID: NCT01723748

Last Updated: 2016-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-05-31

Brief Summary

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

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

Conditions

Acromegaly; Metabolic Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

surgery treated

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

Stimulated with genotropin

Group Type: ACTIVE_COMPARATOR

genotropin

Intervention Type: DRUG

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

SA treated

10 patients with well-controlled acromegaly for at least 6 months after SA treatment Stimulated with genotropin

Group Type: ACTIVE_COMPARATOR

genotropin

Intervention Type: DRUG

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

Interventions

genotropin

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

Intervention Type: DRUG

Other Intervention Names

growth hormone

Eligibility Criteria

Inclusion Criteria

• > 18 years
• treated acromegaly
• considered suitable

Exclusion Criteria

• pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens Otto L Joergensen, professor

Role: STUDY_DIRECTOR

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, Aarhus, Denmark

Countries

Denmark

Other Identifiers

35197

Identifier Type: OTHER

Identifier Source: secondary_id

1-10-72-491-12

Identifier Type: -

Identifier Source: org_study_id