NCT02325271

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

December 19, 2014

Last Update Submit

September 4, 2017

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (8)

  • 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

Secondary Outcomes (12)

  • Glycated hemoglobin (HbA1c)

    Baseline, month 1, 2, 3, 4, 5 and 6

  • High-sensitivity C-reactive protein (hCRP)

    Baseline, month 1, 2, 3, 4, 5 and 6

  • Matrix metallopeptidase 9 (MMP-9)

    Baseline, month 1, 2, 3, 4, 5 and 6

  • MMP-9

    Hourly over 12 hours

  • Adiponectin

    Baseline, month 1, 2, 3, 4, 5 and 6

  • +7 more secondary outcomes

Study Arms (2)

Control group

Subjects with normal glucose tolerance

Other: Frequent blood and urine sampling and blood pressure measurement

Diabetes group

Patients with type 2 diabetes

Other: Frequent blood and urine sampling and blood pressure measurement

Interventions

Frequent blood and urine sampling and blood pressure measurementOTHER

Blood and urine sampling for the determination of VEGF and biomarkers

Control groupDiabetes group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community sample of healthy volunteers, type 2 diabetes patients of the study center

You may qualify if:

  • 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

You may not qualify if:

  • DME
  • hsCRP \> 10 mg/dl
  • Acute infections
  • Acute or chronic inflammatory diseases
  • Immune diseases
  • Treatment with immune suppressive drugs
  • Treatment with glucocorticoids
  • Hemorrhage within the previous 5 years
  • Surgeries within the previous 3 months
  • Oncological diseases
  • Women who are pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GWT-TUD GmbH / Studienzentrum Hanefeld

Dresden, 01307, Germany

Location

Related Publications (1)

  • 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.

    PMID: 28991900DERIVED

Study Officials

  • Markolf Hanefeld, Prof. Dr.

    Study center Prof. Hanefeld, GWT-TUD GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2014

First Posted

December 24, 2014

Study Start

February 1, 2015

Primary Completion

October 1, 2015

Study Completion

January 1, 2016

Last Updated

September 6, 2017

Record last verified: 2017-09

Locations

DE(1)