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

Diabetic Macular Edema Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325271
• Other study ID #: VEGF Bio
• Status: Completed
• Phase: N/A
• First received: December 19, 2014
• Last updated: September 4, 2017
• Start date: February 2015
• Est. completion date: January 2016

Study information

• Verified date: September 2017
• Source: GWT-TUD GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Other:
• Frequent blood and urine sampling and blood pressure measurement
Blood and urine sampling for the determination of VEGF and biomarkers

Locations

Country	Name	City	State
Germany	GWT-TUD GmbH / Studienzentrum Hanefeld	Dresden

Sponsors (2)

Lead Sponsor	Collaborator
GWT-TUD GmbH	Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VEGF-A	Plasma levels determined in the morning under fasted conditions	Baseline, month 1, 2, 3, 4, 5 and 6
Primary	VEGF-B	Plasma levels determined in the morning under fasted conditions	Baseline, month 1, 2, 3, 4, 5 and 6
Primary	VEGF-C	Plasma levels determined in the morning under fasted conditions	Baseline, month 1, 2, 3, 4, 5 and 6
Primary	Placental growth factor	Plasma levels determined in the morning under fasted conditions	Baseline, month 1, 2, 3, 4, 5 and 6
Primary	VEGF-A	Plasma levels determined over the day	Hourly over 12 hours
Primary	VEGF-B	Plasma levels determined over the day	Hourly over 12 hours
Primary	VEGF-C	Plasma levels determined over the day	Hourly over 12 hours
Primary	Placental growth factor	Plasma levels determined over the day	Hourly over 12 hours
Secondary	Glycated hemoglobin (HbA1c)	Plasma levels determined in the morning under fasted conditions	Baseline, month 1, 2, 3, 4, 5 and 6
Secondary	High-sensitivity C-reactive protein (hCRP)	Serum levels determined in the morning under fasted conditions	Baseline, month 1, 2, 3, 4, 5 and 6
Secondary	Matrix metallopeptidase 9 (MMP-9)	Plasma levels determined in the morning under fasted conditions	Baseline, month 1, 2, 3, 4, 5 and 6
Secondary	MMP-9	Plasma levels determined over the day	Hourly over 12 hours
Secondary	Adiponectin	Serum levels determined in the morning under fasted condition	Baseline, month 1, 2, 3, 4, 5 and 6
Secondary	Adiponectin	Serum levels determined over the day	Hourly over 12 hours
Secondary	Cystatin C	Serum levels determined in the morning under fasted condition	Baseline, month 1, 2, 3, 4, 5 and 6
Secondary	Cystatin C	Serum levels determined over the day	Hourly over 12 hours
Secondary	Albumin	Urine levels determined in the morning under fasted condition	Baseline, month 1, 2, 3, 4, 5 and 6
Secondary	Creatinine	Urine levels determined in the morning under fasted condition	Baseline, month 1, 2, 3, 4, 5 and 6
Secondary	Creatinine	Serum levels determined in the morning under fasted condition	Baseline, month 1, 2, 3, 4, 5 and 6
Secondary	Blood pressure		Baseline, month 1, 2, 3, 4, 5 and 6, once over 24 hours