Acromegaly - Before and After Treatment

Cardiovascular Diseases Clinical Trial

Official title:

Sleep Apnea, Circulation and Metabolism in Acromegaly - Before and After Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03431727
• Other study ID #: 1-10-72-126-16
• Status: Recruiting
• Start date: October 1, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2020
• Source: University of Aarhus
• Contact: Mai C Arlien-Søborg, MD
• Phone: +45 23837420
• Email: mas[@]clin.au.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Recently diagnosed with acromegaly

• Age above 18

• Written consent

Exclusion Criteria:

• Pregnancy

Related Conditions & MeSH terms

• Acromegaly
• Bone Diseases
• Cardiovascular Diseases
• Growth Hormone Treatment
• Sleep Apnea
• Sleep Apnea Syndromes

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of internal medicine and endocrinologi	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep apnea	ApneaLinkAir: respiratory effort, puls, oxygen saturation, nasal flow and snoring	At baseline (time of diagnosis) and at an average of 1 years treatment
Primary	Circulation	Sphygmocor: central arterial pressure and pulse wave velocity	At baseline (time of diagnosis) and at an average of 1 years treatment
Primary	Bone metabolism	HRpQCT scan	At baseline (time of diagnosis) and at an average of 1 years treatment
Secondary	Heartfunction	Echocardiography	At baseline (time of diagnosis) and at an average of 1 years treatment
Secondary	Substrate metabolism; signaling proteins	Western blotting	At baseline (time of diagnosis) and at an average of 1 years treatment
Secondary	Substrate metabolism; gene targets	qPCR	At baseline (time of diagnosis) and at an average of 1 years treatment
Secondary	Energy expenditure	Indirect calorimetry	At baseline (time of diagnosis) and at an average of 1 years treatment
Secondary	Body composition	DXA scan	At baseline (time of diagnosis) and at an average of 1 years treatment
Secondary	Physical activity	Sensoriband	At baseline (time of diagnosis) and at an average of 1 years treatment