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

G

GWT-TUD

Status

Completed

Conditions

Diabetic Macular Edema

Treatments

Other: Frequent blood and urine sampling and blood pressure measurement

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02325271
VEGF Bio

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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