Are elevated prolactin levels harmful for the retinal and sublingual microvascular bed?

Are elevated prolactin levels harmful for the retinal and sublingual microvascular bed? - Prolactin and the retinal and sublingual microvascular bed.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32787

Enrollment

Registered

2009-11-27

Start date

2009-12-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

benign pituitary tumor pituitary adenoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: (For both patients as controls, with obviously exception of the first inclusion criteria) Patients (both women and men) with active prolactinoma (either micro- or macroprolactinoma, with prolactin levels above >50 ng/ml Age 20-60 years. Written informed consent

Exclusion criteria

Exclusion criteria: (For both patients as controls) Macroprolactinemie. Infundibulum infiltration. Diabetes mellitus type 2. Pregnant women. Premature atherosclerosis. Use of antidepressive and antipsychotic medication. Presence of co-morbidity that could affect retinal vasculature or its matrix. History of hypersensitivity or allergy to fluorescein. Inability to obtain SDF, fluorescein angiograms or OCT*s of sufficient quality to be analyzed and graded. Active malignancy. Systemic disease with a life expectancy shorter than the duration of the study. Inability to adhere to the protocol with regard to injection and visits. Legally incompetent adult. Refusal to give written informed consent. Additional use of medication that could affect neo-angiogenesis.

Design outcomes

Primary

Measure	Time frame
Main study parameter/endpoint The extent of altered vascular function or morphology in the retina and sublingual tissues in comparison to healthy controls.	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints 1. The difference in inflammatory markers, a vessel wall marker, procoagulant markers, markers of insulin resistance and lipids in patients with a prolactinoma, in comparison to healthy controls. 2. The difference in albuminuria in patients with a prolactinoma in comparison to healthy controls. 3. The extent of tube formation after patient*s plasma is incubated in the in vitro angiogenesis assay, compared to the extent of tube formation upon incubation with plasma from healthy controls. 4. The serum level of 16 kDa prolactin fragments in patients with prolactinoma, in comparison to serum levels in healthy controls.	—

Measure

Time frame

Secondary study parameters/endpoints 1. The difference in inflammatory markers, a vessel wall marker, procoagulant markers, markers of insulin resistance and lipids in patients with a prolactinoma, in comparison to healthy controls. 2. The difference in albuminuria in patients with a prolactinoma in comparison to healthy controls. 3. The extent of tube formation after patient*s plasma is incubated in the in vitro angiogenesis assay, compared to the extent of tube formation upon incubation with plasma from healthy controls. 4. The serum level of 16 kDa prolactin fragments in patients with prolactinoma, in comparison to serum levels in healthy controls.

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Countries

Netherlands

Outcome results