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

GWT-TUD GmbH40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetic Macular Edema

Interventions

Frequent blood and urine sampling and blood pressure measurementOTHER

Blood and urine sampling for the determination of VEGF and biomarkers

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GWT-TUD GmbH / Studienzentrum Hanefeld

Dresden, Germany

Outcomes

Primary Outcomes

VEGF-A

Plasma levels determined in the morning under fasted conditions

Time frame: Baseline, month 1, 2, 3, 4, 5 and 6

VEGF-B

Plasma levels determined in the morning under fasted conditions

Time frame: Baseline, month 1, 2, 3, 4, 5 and 6

VEGF-C

Plasma levels determined in the morning under fasted conditions

Time frame: Baseline, month 1, 2, 3, 4, 5 and 6

Placental growth factor

Plasma levels determined in the morning under fasted conditions

Time frame: Baseline, month 1, 2, 3, 4, 5 and 6

VEGF-A

Plasma levels determined over the day

Time frame: Hourly over 12 hours

VEGF-B

Plasma levels determined over the day

Time frame: Hourly over 12 hours

VEGF-C

Plasma levels determined over the day

Time frame: Hourly over 12 hours

Placental growth factor

Plasma levels determined over the day

Time frame: Hourly over 12 hours

Secondary Outcomes

Glycated hemoglobin (HbA1c)

Plasma levels determined in the morning under fasted conditions

Data from ClinicalTrials.gov

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