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

The role of inflammation in the pathogenesis of cardiovascular morbidity in patients with acromegaly - Inflammation and cardiovasculair morbidity in acromegaly

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45957
Enrollment
240
Registered
2015-12-07
Start date
2016-02-04
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Main study parameters/endpoints: circulating inflammatory markers, metabolic parameters and CV parameters, effects of GH, IGF-1 and oxLDL on immune cells in vitro

Secondary

MeasureTime frame
Vascular ultrasound measurements (IMT, PWV and FMD). Muscle morphometry and inflammatory and metabolic profile. Whole genome analysis. Gut and mouth microbiome. Epigenetic profiles. Urine-analysis.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)