Diabetes MellitusNCT03010956
Changes in Arterial Stiffness and Endothelial Glycocalyx in Patients With Poorly Controlled Diabetes Mellitus Type 1 or Type 2 After Optimization of Antidiabetic Medication.
An observational study of Diabetes Mellitus, run by University of Athens at 1 site in Greece.
Trial summary
Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover, the integrity of endothelial glycocalyx plays a vital role in vascular permeability, inflammation and elasticity. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2014to Nov 2017
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of 30 patients with uncontrolled type 1 diabetes and 30 patients with uncontrolled type 2 diabetes.
Who may be able to join
- Patients with uncontrolled diabetes mellitus
Who cannot join
- valvular heart disease
- congestive heart failure
- peripheral vascular disease
- liver or kidney failure
- history of alcohol or drug abuse
- treatment with statins, beta- blockers, ACE inhibitors or sartans
Trial locations and contacts
1 site in 1 country.
About this study
Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover, the integrity of endothelial glycocalyx plays a vital role in vascular permeability, inflammation and elasticity. The purpose of this study is to investigate changes in arterial stiffness and endothelial glycocalyx thickness in patients with poorly controlled diabetes mellitus type 1 or type 2 after glycemic control by optimal medication.
Read the detailed description
The investigators will study two groups matched for age and sex: 30 patients with uncontrolled type 1 diabetes and 30 patients with uncontrolled type 2 diabetes. Individuals should not be treated with statins, beta-blockers, ACE inhibitors, sartans, hormonal preparations, drugs that interfere with the function of platelets and hemostasis. Furthermore, they should not have heart failure, nephropathy and retinopathy. 10 people will remain uncontrolled after the expiration of 3 months after the modification of antidiabetic medication used as a control group .
At 0, 3, 6 and 12 months the investigators will measure:
- Carotid-femoral pulse wave velocity (PWV, m/sec) and augmentation index (AI%) by the method of arteriography (Arteriograph, TensioMed) and Complior (SP ALAM).
- Perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels (ranged from 5-25 micrometers) using Sideview Darkfield imaging (Microscan, Glycocheck). Increased PBR is considered an accurate non invasive index of reduced endothelial glucocalyx thickness.
- Flow mediated dilatation (FMD) of the brachial artery.
- Determination of following parameters in blood: glucose, insulin, free fatty acids, triglycerides, glycerol, C-reactive protein (CRP), transforming growth factor-b (TGF-b), Lipoprotein-Associated Phospholipase A2 (LP-LPA2), tumor necrosis factor-a (TNF-a), IL6 and IL10 (interleukins), propeptide of type I procollagen (PIP), propeptide of procollagen type III (PIIINP), matrix metallopeptidases 9 and 2 (MMP), macrophage-colony stimulating factor (MCSF), growth differentiation factor-15 (GDF-15), N-terminal pro b-type natriuretic peptide (NT-proBNP) and galectin-3.
- Conditions
- Diabetes Mellitus
- Keywords
- Arterial stiffness, Endothelial glycocalyx, Coronary flow reserve
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with uncontrolled diabetes mellitus | Patients with uncotrolled tyre 1 or type 2 diabetes mellitus | |
| Patients with controlled diabetes mellitus | Patients with controlled type 1 or type 2 diabetes mellitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in pulse wave velocity at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
Differences in pulse wave velocity (PWV, m/sec) using tonometry at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
Measured: Baseline, 3 months, 6 months, and 12 months.
Differences in augmentation index at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
Differences in augmentation index (AI,%) using oscillometry at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
Measured: Baseline, 3 months, 6 months, and 12 months.
Differences in endothelial glycocalyx at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
Differences in endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication. High PBR values represent reduced glycocalyx thickness.
Measured: Baseline, 3 months, 6 months, and 12 months.
Differences in flow mediated dilation (FMD) at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
Differences in flow mediated dilatation (FMD) of the brachial artery at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
Measured: Baseline, 3 months, 6 months, and 12 months.
Secondary outcomes (2)
Endothelial glycocalyx and pulse wave velocity.
Association of endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels with pulse wave velocity (PWV, m/sec) after optimization of antidiabetic medication.
Measured: Baseline, 3 months, 6 months, and 12 months.
Endothelial glycocalyx and coronary flow reserve.
Association of endothelial glycocalyx as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels with coronary flow reserve (CFR) after optimization of antidiabetic medication.
Measured: Baseline, 3 months, 6 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startNov 2014
- Primary completionJun 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignatios Ikonomidis, University of Athens
- Investigators
- Ignatios Ikonomidis, MD, Principal investigator, 2nd Cardiology Department, University of Athens, GreeceGeorge Pavlidis, MD, Principal investigator, 2nd Cardiology Department, University of Athens, GreeceVaia Lambadiari, MD, Principal investigator, 2nd Department of Internal Medicine, University of Athens, GreeceFotini Kousathana, MD, Principal investigator, 2nd Department of Internal Medicine, University of Athens, GreeceConstantinos Tymbas, MD, Principal investigator, 2nd Cardiology Department, University of Athens, GreeceGeorge Dimitriadis, MD, Principal investigator, 2nd Department of Internal Medicine, University of Athens, GreeceJohn Lekakis, MD, Principal investigator, 2nd Cardiology Department, University of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010956
- Sponsor's protocol ID
- S-DM-ATTIKON
- Status last verified
- Oct 2018
- First submitted
- 22 Dec 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Arterial Stiffness and Endothelial Glycocalyx in Patients With Poorly Controlled Diabetes Mellitus Type 1 or Type 2 After Optimization of Antidiabetic Medication.
- ClinicalTrials.gov ID
- NCT03010956
- Acronym / sponsor ID
- S-DM-ATTIKON
- Conditions
- Diabetes Mellitus
- Keywords
- Arterial stiffness, Endothelial glycocalyx, Coronary flow reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 5 Jan 2017 (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.
Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover, the integrity of endothelial glycocalyx plays a vital role in vascular permeability, inflammation and elasticity. The purpose of this study is to investigate changes in arterial stiffness and endothelial glycocalyx thickness in patients with poorly controlled diabetes mellitus type 1 or type 2 after glycemic control by optimal medication.
Detailed description
The investigators will study two groups matched for age and sex: 30 patients with uncontrolled type 1 diabetes and 30 patients with uncontrolled type 2 diabetes. Individuals should not be treated with statins, beta-blockers, ACE inhibitors, sartans, hormonal preparations, drugs that interfere with the function of platelets and hemostasis. Furthermore, they should not have heart failure, nephropathy and retinopathy. 10 people will remain uncontrolled after the expiration of 3 months after the modification of antidiabetic medication used as a control group .
At 0, 3, 6 and 12 months the investigators will measure:
- Carotid-femoral pulse wave velocity (PWV, m/sec) and augmentation index (AI%) by the method of arteriography (Arteriograph, TensioMed) and Complior (SP ALAM).
- Perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels (ranged from 5-25 micrometers) using Sideview Darkfield imaging (Microscan, Glycocheck). Increased PBR is considered an accurate non invasive index of reduced endothelial glucocalyx thickness.
- Flow mediated dilatation (FMD) of the brachial artery.
- Determination of following parameters in blood: glucose, insulin, free fatty acids, triglycerides, glycerol, C-reactive protein (CRP), transforming growth factor-b (TGF-b), Lipoprotein-Associated Phospholipase A2 (LP-LPA2), tumor necrosis factor-a (TNF-a), IL6 and IL10 (interleukins), propeptide of type I procollagen (PIP), propeptide of procollagen type III (PIIINP), matrix metallopeptidases 9 and 2 (MMP), macrophage-colony stimulating factor (MCSF), growth differentiation factor-15 (GDF-15), N-terminal pro b-type natriuretic peptide (NT-proBNP) and galectin-3.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with uncontrolled diabetes mellitus | – | –Patients with uncotrolled tyre 1 or type 2 diabetes mellitus |
| Patients with controlled diabetes mellitus | – | –Patients with controlled type 1 or type 2 diabetes mellitus |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 30 patients with uncontrolled type 1 diabetes and 30 patients with uncontrolled type 2 diabetes.
Key inclusion criteria (1 listed)
- Patients with uncontrolled diabetes mellitus
Key exclusion criteria (6 listed)
- valvular heart disease
- congestive heart failure
- peripheral vascular disease
- liver or kidney failure
- history of alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in pulse wave velocity at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
Time frame: Baseline, 3 months, 6 months, and 12 months.
Differences in pulse wave velocity (PWV, m/sec) using tonometry at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
Differences in augmentation index at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
Time frame: Baseline, 3 months, 6 months, and 12 months.
Differences in augmentation index (AI,%) using oscillometry at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
Differences in endothelial glycocalyx at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
Time frame: Baseline, 3 months, 6 months, and 12 months.
Differences in endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication. High PBR values represent reduced glycocalyx thickness.
Differences in flow mediated dilation (FMD) at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
Time frame: Baseline, 3 months, 6 months, and 12 months.
Differences in flow mediated dilatation (FMD) of the brachial artery at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
2 secondary outcomes
Endothelial glycocalyx and pulse wave velocity.
Time frame: Baseline, 3 months, 6 months, and 12 months.
Endothelial glycocalyx and coronary flow reserve.
Time frame: Baseline, 3 months, 6 months, and 12 months.
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 11 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Ignatios Ikonomidis, MD principal investigator
2nd Cardiology Department, University of Athens, Greece
George Pavlidis, MD principal investigator
2nd Cardiology Department, University of Athens, Greece
Vaia Lambadiari, MD principal investigator
2nd Department of Internal Medicine, University of Athens, Greece
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 Diabetes Mellitus, run by University of Athens at 1 site in Greece.
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 1 inclusion and 6 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 11 Oct 2018. 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 Greece. 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?
Differences in pulse wave velocity at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication. (time frame: Baseline, 3 months, 6 months, and 12 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2018.