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

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Other: Frequent blood and urine sampling and blood pressure measurement

• Registration Number: NCT02325271
• Lead Sponsor: GWT-TUD GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-24
• Study Start: 2015-02
• Primary Completion: 2015-10
• Study Completion: 2016-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-04
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetes group	Frequent blood and urine sampling and blood pressure measurement	Patients with type 2 diabetes
Control group	Frequent blood and urine sampling and blood pressure measurement	Subjects with normal glucose tolerance

Primary Outcome Measures

Name	Time	Method
VEGF-C	Hourly over 12 hours	Plasma levels determined over the day
VEGF-B	Hourly over 12 hours	Plasma levels determined over the day
Placental growth factor	Hourly over 12 hours	Plasma levels determined over the day
VEGF-A	Hourly over 12 hours	Plasma levels determined over the day

Secondary Outcome Measures

Name	Time	Method
Cystatin C	Hourly over 12 hours	Serum levels determined over the day
Glycated hemoglobin (HbA1c)	Baseline, month 1, 2, 3, 4, 5 and 6	Plasma levels determined in the morning under fasted conditions
Albumin	Baseline, month 1, 2, 3, 4, 5 and 6	Urine levels determined in the morning under fasted condition
Blood pressure	Baseline, month 1, 2, 3, 4, 5 and 6, once over 24 hours
High-sensitivity C-reactive protein (hCRP)	Baseline, month 1, 2, 3, 4, 5 and 6	Serum levels determined in the morning under fasted conditions
MMP-9	Hourly over 12 hours	Plasma levels determined over the day
Adiponectin	Hourly over 12 hours	Serum levels determined over the day
Matrix metallopeptidase 9 (MMP-9)	Baseline, month 1, 2, 3, 4, 5 and 6	Plasma levels determined in the morning under fasted conditions
Creatinine	Baseline, month 1, 2, 3, 4, 5 and 6	Serum levels determined in the morning under fasted condition

Trial Locations

Locations (1)

GWT-TUD GmbH / Studienzentrum Hanefeld; 🇩🇪 Dresden, Germany