Acromegaly - Before and After Treatment

• Conditions: Cardiovascular Diseases; Growth Hormone Treatment; Sleep Apnea; Bone Diseases; Acromegaly

• Registration Number: NCT03431727
• Lead Sponsor: University of Aarhus

Brief Summary

The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly before and after surgery and/or medical treatment.

Detailed Description

Acromegaly is a rare disease caused by a growth hormone (GH) producing pituitary adenoma. Surgery is primary treatment, whereas medical treatment with a somatostatin analogue (SA), which suppresses GH secretion and reduces tumour size, is used when surgery is insufficient or unfeasible. Acromegaly is associated with metabolic abnormalities which contributes to an increased morbidity and mortality if left untreated. To which extend these abnormalities reverses after treatment, and if treatment modality influences the outcome, remain elusive. The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly before and after surgery and/or medical treatment

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-13
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-04
• Last Update Posted: 2020-12-07
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Recently diagnosed with acromegaly
• Age above 18
• Written consent

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Exclusion Criteria

• Pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Circulation	At baseline (time of diagnosis) and at an average of 1 years treatment	Sphygmocor: central arterial pressure and pulse wave velocity
Bone metabolism	At baseline (time of diagnosis) and at an average of 1 years treatment	HRpQCT scan
Sleep apnea	At baseline (time of diagnosis) and at an average of 1 years treatment	ApneaLinkAir: respiratory effort, puls, oxygen saturation, nasal flow and snoring

Secondary Outcome Measures

Name	Time	Method
Heartfunction	At baseline (time of diagnosis) and at an average of 1 years treatment	Echocardiography
Substrate metabolism; signaling proteins	At baseline (time of diagnosis) and at an average of 1 years treatment	Western blotting
Physical activity	At baseline (time of diagnosis) and at an average of 1 years treatment	Sensoriband
Body composition	At baseline (time of diagnosis) and at an average of 1 years treatment	DXA scan
Substrate metabolism; gene targets	At baseline (time of diagnosis) and at an average of 1 years treatment	qPCR
Energy expenditure	At baseline (time of diagnosis) and at an average of 1 years treatment	Indirect calorimetry

Trial Locations

Locations (1)

Aarhus University Hospital, Department of internal medicine and endocrinologi; 🇩🇰 Aarhus, Denmark