Diabetic Macular EdemaNCT02325271
Intra-individual Variability and Circadian Rhythm of VEGF Levels and Interaction With Biomarkers
An observational study of Diabetic Macular Edema, run by GWT-TUD GmbH at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Frequent blood and urine sampling and blood pressure measurement
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample of healthy volunteers, type 2 diabetes patients of the study center
Who may be able to join
- 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
Who cannot join
- DME
- hsCRP > 10 mg/dl
- Acute infections
- Acute or chronic inflammatory diseases
- Immune diseases
- Treatment with immune suppressive drugs
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Diabetic Macular Edema
- Being tested
- Frequent blood and urine sampling and blood pressure measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequent blood and urine sampling and blood pressure measurementOther
Blood and urine sampling for the determination of VEGF and biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Control group | Subjects with normal glucose tolerance Receives: Other: Frequent blood and urine sampling and blood pressure measurement | |
| Diabetes group | Patients with type 2 diabetes Receives: Other: Frequent blood and urine sampling and blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
VEGF-A
Plasma levels determined in the morning under fasted conditions
Measured: Baseline, month 1, 2, 3, 4, 5 and 6
VEGF-B
Plasma levels determined in the morning under fasted conditions
Measured: Baseline, month 1, 2, 3, 4, 5 and 6
VEGF-C
Plasma levels determined in the morning under fasted conditions
Measured: Baseline, month 1, 2, 3, 4, 5 and 6
Placental growth factor
Plasma levels determined in the morning under fasted conditions
Measured: Baseline, month 1, 2, 3, 4, 5 and 6
VEGF-A
Plasma levels determined over the day
Measured: Hourly over 12 hours
VEGF-B
Plasma levels determined over the day
Measured: Hourly over 12 hours
VEGF-C
Plasma levels determined over the day
Measured: Hourly over 12 hours
Placental growth factor
Plasma levels determined over the day
Measured: Hourly over 12 hours
Secondary outcomes (12)
Glycated hemoglobin (HbA1c)
Plasma levels determined in the morning under fasted conditions
Measured: Baseline, month 1, 2, 3, 4, 5 and 6
High-sensitivity C-reactive protein (hCRP)
Serum levels determined in the morning under fasted conditions
Measured: Baseline, month 1, 2, 3, 4, 5 and 6
Matrix metallopeptidase 9 (MMP-9)
Plasma levels determined in the morning under fasted conditions
Measured: Baseline, month 1, 2, 3, 4, 5 and 6
MMP-9
Plasma levels determined over the day
Measured: Hourly over 12 hours
Adiponectin
Serum levels determined in the morning under fasted condition
Measured: Baseline, month 1, 2, 3, 4, 5 and 6
Adiponectin
Serum levels determined over the day
Measured: Hourly over 12 hours
Cystatin C
Serum levels determined in the morning under fasted condition
Measured: Baseline, month 1, 2, 3, 4, 5 and 6
Cystatin C
Serum levels determined over the day
Measured: Hourly over 12 hours
Albumin
Urine levels determined in the morning under fasted condition
Measured: Baseline, month 1, 2, 3, 4, 5 and 6
Creatinine
Urine levels determined in the morning under fasted condition
Measured: Baseline, month 1, 2, 3, 4, 5 and 6
Creatinine
Serum levels determined in the morning under fasted condition
Measured: Baseline, month 1, 2, 3, 4, 5 and 6
Blood pressure
Measured: Baseline, month 1, 2, 3, 4, 5 and 6, once over 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionOct 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- GWT-TUD GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Markolf Hanefeld, Prof. Dr., Principal investigator, Study center Prof. Hanefeld, GWT-TUD GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325271
- Sponsor's protocol ID
- VEGF Bio
- Status last verified
- Sep 2017
- First submitted
- 19 Dec 2014
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28991900
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02325271
- Acronym / sponsor ID
- VEGF Bio
- Conditions
- Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- GWT-TUD GmbHUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Feb 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Frequent blood and urine sampling and blood pressure measurementSubjects with normal glucose tolerance |
| Diabetes group | – | Other: Frequent blood and urine sampling and blood pressure measurementPatients with type 2 diabetes |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample of healthy volunteers, type 2 diabetes patients of the study center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- DME
- hsCRP > 10 mg/dl
- Acute infections
- Acute or chronic inflammatory diseases
- Immune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frequent blood and urine sampling and blood pressure measurementBlood and urine sampling for the determination of VEGF and biomarkers | Other | Control group, Diabetes group |
Primary outcome
VEGF-A
Time frame: Baseline, month 1, 2, 3, 4, 5 and 6
Plasma levels determined in the morning under fasted conditions
VEGF-B
Time frame: Baseline, month 1, 2, 3, 4, 5 and 6
Plasma levels determined in the morning under fasted conditions
VEGF-C
Time frame: Baseline, month 1, 2, 3, 4, 5 and 6
Plasma levels determined in the morning under fasted conditions
Placental growth factor
Time frame: Baseline, month 1, 2, 3, 4, 5 and 6
Plasma levels determined in the morning under fasted conditions
VEGF-A
Time frame: Hourly over 12 hours
Plasma levels determined over the day
VEGF-B
Time frame: Hourly over 12 hours
Plasma levels determined over the day
VEGF-C
Time frame: Hourly over 12 hours
Plasma levels determined over the day
Placental growth factor
Time frame: Hourly over 12 hours
Plasma levels determined over the day
12 secondary outcomes
Glycated hemoglobin (HbA1c)
Time frame: 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
Matrix metallopeptidase 9 (MMP-9)
Time frame: Baseline, month 1, 2, 3, 4, 5 and 6
MMP-9
Time frame: Hourly over 12 hours
Adiponectin
Time frame: Baseline, month 1, 2, 3, 4, 5 and 6
Adiponectin
Time frame: Hourly over 12 hours
Cystatin C
Time frame: Baseline, month 1, 2, 3, 4, 5 and 6
Cystatin C
Time frame: Hourly over 12 hours
Albumin
Time frame: Baseline, month 1, 2, 3, 4, 5 and 6
Creatinine
Time frame: Baseline, month 1, 2, 3, 4, 5 and 6
Creatinine
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Derived from this study: PubMed 28991900Hanefeld 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markolf Hanefeld, Prof. Dr. principal investigator
Study center Prof. Hanefeld, GWT-TUD GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by GWT-TUD GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VEGF-A (time frame: Baseline, month 1, 2, 3, 4, 5 and 6). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02325271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.