Acromegaly - Before and After Treatment

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

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

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; Bone Diseases; Sleep Apnea; Acromegaly; Growth Hormone 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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Recruiting
    • Aarhus University Hospital, Department of internal medicine and endocrinologi
    • Contact: Mai C Arlien-Søborg, MD; Phone Number: +45 23837420; Email: mas@clin.au.dk
    • Principal Investigator: Jens Otto L Jørgensen, Professor
    • Sub-Investigator: Mai C Arlien-Søborg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed acromegalic patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Circulation	Sphygmocor: central arterial pressure and pulse wave velocity	At baseline (time of diagnosis) and at an average of 1 years treatment
Bone metabolism	HRpQCT scan	At baseline (time of diagnosis) and at an average of 1 years treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Jens Otto L Jørgensen, Porfessor, Aarhus University Hospital, Department of internal medicine and endocrinology

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 22, 2017
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): December 7, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Pituitary Diseases; Sleep Apnea Syndromes; Cardiovascular Diseases; Acromegaly; Bone Diseases
• Other Study ID Numbers: 1-10-72-126-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No