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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Subjects with normal glucose tolerance |
| |
| Diabetes group | Patients with type 2 diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frequent blood and urine sampling and blood pressure measurement | Other | Blood and urine sampling for the determination of VEGF and biomarkers |
|
| Measure | Description | Time Frame |
|---|---|---|
| VEGF-A | Plasma levels determined in the morning under fasted conditions | Baseline, month 1, 2, 3, 4, 5 and 6 |
| VEGF-B | Plasma levels determined in the morning under fasted conditions | Baseline, month 1, 2, 3, 4, 5 and 6 |
| VEGF-C | Plasma levels determined in the morning under fasted conditions | Baseline, month 1, 2, 3, 4, 5 and 6 |
| Placental growth factor | Plasma levels determined in the morning under fasted conditions | Baseline, month 1, 2, 3, 4, 5 and 6 |
| VEGF-A | Plasma levels determined over the day | Hourly over 12 hours |
| VEGF-B | Plasma levels determined over the day | Hourly over 12 hours |
| VEGF-C | Plasma levels determined over the day | Hourly over 12 hours |
| Placental growth factor | Plasma levels determined over the day | Hourly over 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated hemoglobin (HbA1c) | Plasma levels determined in the morning under fasted conditions | Baseline, month 1, 2, 3, 4, 5 and 6 |
| High-sensitivity C-reactive protein (hCRP) | Serum levels determined in the morning under fasted conditions |
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Inclusion Criteria:
Exclusion Criteria:
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Community sample of healthy volunteers, type 2 diabetes patients of the study center
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| Name | Affiliation | Role |
|---|---|---|
| Markolf Hanefeld, Prof. Dr. | Study center Prof. Hanefeld, GWT-TUD GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GWT-TUD GmbH / Studienzentrum Hanefeld | Dresden | 01307 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28991900 | Derived | 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. |
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| Baseline, month 1, 2, 3, 4, 5 and 6 |
| Matrix metallopeptidase 9 (MMP-9) | Plasma levels determined in the morning under fasted conditions | Baseline, month 1, 2, 3, 4, 5 and 6 |
| MMP-9 | Plasma levels determined over the day | Hourly over 12 hours |
| Adiponectin | Serum levels determined in the morning under fasted condition | Baseline, month 1, 2, 3, 4, 5 and 6 |
| Adiponectin | Serum levels determined over the day | Hourly over 12 hours |
| Cystatin C | Serum levels determined in the morning under fasted condition | Baseline, month 1, 2, 3, 4, 5 and 6 |
| Cystatin C | Serum levels determined over the day | Hourly over 12 hours |
| Albumin | Urine levels determined in the morning under fasted condition | Baseline, month 1, 2, 3, 4, 5 and 6 |
| Creatinine | Urine levels determined in the morning under fasted condition | Baseline, month 1, 2, 3, 4, 5 and 6 |
| Creatinine | Serum levels determined in the morning under fasted condition | Baseline, month 1, 2, 3, 4, 5 and 6 |
| Blood pressure | Baseline, month 1, 2, 3, 4, 5 and 6, once over 24 hours |