Clinical trial NCT02325271: Intra-individual Variability and Circadian Rhythm of VEGF Levels and Interaction With Biomarkers
Official 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2014-12-24
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample of healthy volunteers, type 2 diabetes patients of the study center

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.


Eligibility criteria: 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

Primary outcomes:
measure: VEGF-A
timeFrame: Baseline, month 1, 2, 3, 4, 5 and 6
measure: VEGF-B
timeFrame: Baseline, month 1, 2, 3, 4, 5 and 6
measure: VEGF-C
timeFrame: Baseline, month 1, 2, 3, 4, 5 and 6
measure: Placental growth factor
timeFrame: Baseline, month 1, 2, 3, 4, 5 and 6
measure: VEGF-A
timeFrame: Hourly over 12 hours
measure: VEGF-B
timeFrame: Hourly over 12 hours
measure: VEGF-C
timeFrame: Hourly over 12 hours
measure: Placental growth factor
timeFrame: Hourly over 12 hours
Secondary outcomes:
measure: Glycated hemoglobin (HbA1c)
timeFrame: Baseline, month 1, 2, 3, 4, 5 and 6
measure: High-sensitivity C-reactive protein (hCRP)
timeFrame: Baseline, month 1, 2, 3, 4, 5 and 6
measure: Matrix metallopeptidase 9 (MMP-9)
timeFrame: Baseline, month 1, 2, 3, 4, 5 and 6
measure: MMP-9
timeFrame: Hourly over 12 hours
measure: Adiponectin
timeFrame: Baseline, month 1, 2, 3, 4, 5 and 6
measure: Adiponectin
timeFrame: Hourly over 12 hours
measure: Cystatin C
timeFrame: Baseline, month 1, 2, 3, 4, 5 and 6
measure: Cystatin C
timeFrame: Hourly over 12 hours
measure: Albumin
timeFrame: Baseline, month 1, 2, 3, 4, 5 and 6
measure: Creatinine
timeFrame: Baseline, month 1, 2, 3, 4, 5 and 6
measure: Creatinine
timeFrame: Baseline, month 1, 2, 3, 4, 5 and 6
measure: Blood pressure
timeFrame: Baseline, month 1, 2, 3, 4, 5 and 6, once over 24 hours
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: GWT-TUD GmbH / Studienzentrum Hanefeld
Study officials:
affiliation: Study center Prof. Hanefeld, GWT-TUD GmbH
name: Markolf Hanefeld, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hanefeld M, Engelmann K, Appelt D, Sandner D, Weigmann I, Ganz X, Pistrosch F, Kohler C, Gasparic A, Birkenfeld AL. Intra-individual variability and circadian rhythm of vascular endothelial growth factors in subjects with normal glucose tolerance and type 2 diabetes. PLoS One. 2017 Oct 9;12(10):e0184234. doi: 10.1371/journal.pone.0184234. eCollection 2017.