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Completed

NCT Number: NCT02325271

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

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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Key information

Conditions

Diabetic Macular Edema

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GWT-TUD GmbH / Studienzentrum Hanefeld

Dresden, 01307, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frequent blood and urine sampling and blood pressure measurement

Other

Blood and urine sampling for the determination of VEGF and biomarkers

Primary outcomes

  1. VEGF-A

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

    Plasma levels determined in the morning under fasted conditions

  2. VEGF-B

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

    Plasma levels determined in the morning under fasted conditions

  3. VEGF-C

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

    Plasma levels determined in the morning under fasted conditions

  4. Placental growth factor

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

    Plasma levels determined in the morning under fasted conditions

  5. VEGF-A

    Time frame: Hourly over 12 hours

    Plasma levels determined over the day

  6. VEGF-B

    Time frame: Hourly over 12 hours

    Plasma levels determined over the day

  7. VEGF-C

    Time frame: Hourly over 12 hours

    Plasma levels determined over the day

  8. Placental growth factor

    Time frame: Hourly over 12 hours

    Plasma levels determined over the day

Secondary outcomes

  1. Glycated hemoglobin (HbA1c)

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

    Plasma levels determined in the morning under fasted conditions

  2. High-sensitivity C-reactive protein (hCRP)

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

    Serum levels determined in the morning under fasted conditions

  3. Matrix metallopeptidase 9 (MMP-9)

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

    Plasma levels determined in the morning under fasted conditions

  4. MMP-9

    Time frame: Hourly over 12 hours

    Plasma levels determined over the day

  5. Adiponectin

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

    Serum levels determined in the morning under fasted condition

  6. Adiponectin

    Time frame: Hourly over 12 hours

    Serum levels determined over the day

  7. Cystatin C

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

    Serum levels determined in the morning under fasted condition

  8. Cystatin C

    Time frame: Hourly over 12 hours

    Serum levels determined over the day

  9. Albumin

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

    Urine levels determined in the morning under fasted condition

  10. Creatinine

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

    Urine levels determined in the morning under fasted condition

  11. Creatinine

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

    Serum levels determined in the morning under fasted condition

  12. Blood pressure

    Time frame: Baseline, month 1, 2, 3, 4, 5 and 6, once over 24 hours

Sponsors and collaborators

Lead sponsor

GWT-TUD GmbH

Other

Collaborators

  • Novartis

Registry information

Official study title

Intra-individual Variability and Circadian Rhythm of Systemic Vascular Endothelial Growth Factor (VEGF) Levels and Interaction With Biomarkers of Inflammation in Subjects With Normal Glucose Tolerance (NGT) and Patients With Type 2 Diabetes Without Diabetic Macular Edema (DME)

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Dec 24, 2014
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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