- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02325271
Intra-individual Variability and Circadian Rhythm of VEGF Levels and Interaction With Biomarkers
September 4, 2017 updated by: GWT-TUD GmbH
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dresden, Germany, 01307
- GWT-TUD GmbH / Studienzentrum Hanefeld
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Community sample of healthy volunteers, type 2 diabetes patients of the study center
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control group
Subjects with normal glucose tolerance
|
Blood and urine sampling for the determination of VEGF and biomarkers
|
Diabetes group
Patients with type 2 diabetes
|
Blood and urine sampling for the determination of VEGF and biomarkers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VEGF-A
Time Frame: Baseline, month 1, 2, 3, 4, 5 and 6
|
Plasma levels determined in the morning under fasted conditions
|
Baseline, month 1, 2, 3, 4, 5 and 6
|
VEGF-B
Time Frame: Baseline, month 1, 2, 3, 4, 5 and 6
|
Plasma levels determined in the morning under fasted conditions
|
Baseline, month 1, 2, 3, 4, 5 and 6
|
VEGF-C
Time Frame: Baseline, month 1, 2, 3, 4, 5 and 6
|
Plasma levels determined in the morning under fasted conditions
|
Baseline, month 1, 2, 3, 4, 5 and 6
|
Placental growth factor
Time Frame: Baseline, month 1, 2, 3, 4, 5 and 6
|
Plasma levels determined in the morning under fasted conditions
|
Baseline, month 1, 2, 3, 4, 5 and 6
|
VEGF-A
Time Frame: Hourly over 12 hours
|
Plasma levels determined over the day
|
Hourly over 12 hours
|
VEGF-B
Time Frame: Hourly over 12 hours
|
Plasma levels determined over the day
|
Hourly over 12 hours
|
VEGF-C
Time Frame: Hourly over 12 hours
|
Plasma levels determined over the day
|
Hourly over 12 hours
|
Placental growth factor
Time Frame: Hourly over 12 hours
|
Plasma levels determined over the day
|
Hourly over 12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycated hemoglobin (HbA1c)
Time Frame: Baseline, month 1, 2, 3, 4, 5 and 6
|
Plasma levels determined in the morning under fasted conditions
|
Baseline, month 1, 2, 3, 4, 5 and 6
|
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
|
Baseline, month 1, 2, 3, 4, 5 and 6
|
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
|
Baseline, month 1, 2, 3, 4, 5 and 6
|
MMP-9
Time Frame: Hourly over 12 hours
|
Plasma levels determined over the day
|
Hourly over 12 hours
|
Adiponectin
Time Frame: Baseline, month 1, 2, 3, 4, 5 and 6
|
Serum levels determined in the morning under fasted condition
|
Baseline, month 1, 2, 3, 4, 5 and 6
|
Adiponectin
Time Frame: Hourly over 12 hours
|
Serum levels determined over the day
|
Hourly over 12 hours
|
Cystatin C
Time Frame: Baseline, month 1, 2, 3, 4, 5 and 6
|
Serum levels determined in the morning under fasted condition
|
Baseline, month 1, 2, 3, 4, 5 and 6
|
Cystatin C
Time Frame: Hourly over 12 hours
|
Serum levels determined over the day
|
Hourly over 12 hours
|
Albumin
Time Frame: Baseline, month 1, 2, 3, 4, 5 and 6
|
Urine levels determined in the morning under fasted condition
|
Baseline, month 1, 2, 3, 4, 5 and 6
|
Creatinine
Time Frame: Baseline, month 1, 2, 3, 4, 5 and 6
|
Urine levels determined in the morning under fasted condition
|
Baseline, month 1, 2, 3, 4, 5 and 6
|
Creatinine
Time Frame: Baseline, month 1, 2, 3, 4, 5 and 6
|
Serum levels determined in the morning under fasted condition
|
Baseline, month 1, 2, 3, 4, 5 and 6
|
Blood pressure
Time Frame: Baseline, month 1, 2, 3, 4, 5 and 6, once over 24 hours
|
Baseline, month 1, 2, 3, 4, 5 and 6, once over 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Markolf Hanefeld, Prof. Dr., Study center Prof. Hanefeld, GWT-TUD GmbH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
December 19, 2014
First Submitted That Met QC Criteria
December 19, 2014
First Posted (Estimate)
December 24, 2014
Study Record Updates
Last Update Posted (Actual)
September 6, 2017
Last Update Submitted That Met QC Criteria
September 4, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VEGF Bio
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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