The role of inflammation in the pathogenesis of cardiovascular morbidity in patients with acromegaly

Completed

• Conditions: Acromegaly; 10021112

• Registration Number: NL-OMON45957
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

Biochemically confirmed diagnosis of acromegaly by an increased IGF-1 level (e.i. mean > 2 standard deviations (SD) for age and sex) and an insufficient suppression of serum GH levels (e.i. GH *1 mU/l) during an oral glucose tolerance test (OGTT).

Exclusion Criteria

Excluded from participation in this study will be subjects who are/have:
* Mentally incompetent;
* Pregnant or breastfeeding;
* Inadequately supplied, unstable or untreated hormonal deficiencies;
* Known inflammatory or infectious diseases or an immunosuppressive status;
* Using hormonal therapy: hormonal contraceptives (42) or hormonal substitution therapy (only applicable for the subgroups of patients);
* Using medication interfering with adiponectines, such as thiazolidinediones;
* Severe comorbidities: active malignancy (except for basal cell carcinoma), serious psychiatric pathology;
* A systolic blood pressure *160 mmHg and/or a diastolic blood pressure *100 mmHg;
* Known untreated or unstable diabetes mellitus or ischemic cardiovascular disease;
* A self-reported alcohol consumption of >21 units per week.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: circulating inflammatory markers, metabolic<br /><br>parameters and CV parameters, effects of GH, IGF-1 and oxLDL on immune cells in<br /><br>vitro </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Vascular ultrasound measurements (IMT, PWV and FMD). Muscle morphometry and<br /><br>inflammatory and metabolic profile. Whole genome analysis. Gut and mouth<br /><br>microbiome. Epigenetic profiles. Urine-analysis.</p><br>