Intra-individual Variability and Circadian Rhythm of VEGF Levels and Interaction With Biomarkers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-01-31

Brief Summary

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The study evaluates the intra-individual variability of VEGF levels over a period of 6 months as well as the circadian variation of VEGF levels, both under standardized conditions in patients with type 2 diabetes without DME and matched subjects with normal glucose tolerance (NGT). Secondary objectives of the study are to evaluate the relationship of individual VEGF-levels to biomarkers of inflammation, HbA1c and major cardiovascular risk factors.

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Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

Subjects with normal glucose tolerance

Frequent blood and urine sampling and blood pressure measurement

Intervention Type OTHER

Blood and urine sampling for the determination of VEGF and biomarkers

Diabetes group

Patients with type 2 diabetes

Frequent blood and urine sampling and blood pressure measurement

Intervention Type OTHER

Blood and urine sampling for the determination of VEGF and biomarkers

Interventions

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Frequent blood and urine sampling and blood pressure measurement

Blood and urine sampling for the determination of VEGF and biomarkers

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Age equal to or between 50 and 80 years
* Subjects with normal glucose tolerance confirmed by glucose tolerance test (control group) or patients with type 2 diabetes: diabetes duration 5-25 years; HbA1c equal to or between 6.5 and 9% (diabetes group)
* Ability to understand and follow study-related instructions

Exclusion Criteria

* DME
* hsCRP \> 10 mg/dl
* Acute infections
* Acute or chronic inflammatory diseases
* Immune diseases
* Treatment with immune suppressive drugs
* Treatment with glucocorticoids
* Myocardial infarction and stroke within 1 year before inclusion
* Hemorrhage within the previous 5 years
* Surgeries within the previous 3 months
* Oncological diseases
* Women who are pregnant or breast-feeding

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes