Diabetes MellitusNCT02244736
Vascular Markers During OGTT in Diabetics and First-degree Relatives
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
- Feb 2013to Mar 2015
- How long will I take part?
- 2 Years
- 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: 90 subjects, 30 first degree relatives of diabetics withnormal OGTT (relatives), 30 withnormal OGTT and no family history of diabetes (normals), and 30 with abnormal OGTT (diabetics).
Who may be able to join
- subjects without known diabetes
- first degree relatives of diabetics
Who cannot join
- coronary or valvular heart disease
- congestive heart failure
- peripheral vascular disease
- liver or kidney failure
- history of alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes of the Endothelial Glycocalyx, the Elastic Properties of the Arteries and the Coronary Flow Reserve (CFR) During Oral Glucose Tolerance Test in Patients With New Onset Diabetes Mellitus and First-degree Relatives
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 association between damage of endothelial glycocalyx, impaired arterial elastic properties, and CFR in diabetics and first degree relatives has not been explored. The purpose of this study is to explore the association between damage of endothelial glycocalyx, impaired arterial elastic properties, and CFR in diabetics and first-degree relatives before and after during oral glucose tolerance test (OGTT).
Read the detailed description
The investigators plan to examine 90 subjects without known diabetes a standard 75-gr oral glucose tolerance test (OGTT) will be performed. [30 first degree relatives of diabetics with normal OGTT (relatives), 30 with normal OGTT and no family history of diabetes (normals), and 30 with abnormal OGTT (diabetics) matched for age and sex].
Plasma glucose and serum insulin levels will be measured in venous blood collected at 0, 30, 60, 90 and 120min after glucose loading. At the same time intervals, the investigators will measure:
- the carotid to femoral pulse wave velocity (PWVc) using the Complior apparatus
- the aortic pulse wave velocity (PWVa), central systolic blood pressure (cSBP) and augmentation index (AI) using an oscillometric method (Arteriograph,TensioMed) as markers of arterial stiffness and wave reflections
- the coronary flow reserve (CFR) at baseline and after adenosine infusion (140 μg × kg-1 × min-1) for 3 minutes to assess coronary vasomotor function
- the perfusion 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 glycocalyx thickness.
In addition, the investigators will measure free fatty acids, triglycerides, glycerol, C reactive protein (CRP), transforming growth factor-b (TGF-b), Lipoprotein-Associated Phospholipase A2, (LP-LPA2), tumor necrosis factor (TNF-a), interleukin 6 (IL6) and interleukin 10 (IL10) propeptide of type I procollagen, (PIP), propeptide of procollagen type III (PIIINP), matrix metallopeptidases 9 and 2 (MMP 9 and 2), macrophage-colony stimulating factor ( MCSF).
The investigators will measure insulin resistance a) after fasting, using homeostatic model assessment (HOMA) and hepatic insulin sensitivity (HIS) b) during oral glucose tolerance test (OGTT) using Matsuda index and insulin sensitivity index (ISI). The investigators will categorize patients in those with normal (<140 mg/dl at 120 min) and those with abnormal OGTT (>200mg/dl at 120min).
- 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 |
|---|---|---|
| Controls | Subjects with no family history of diabetes mellitus and normal OGTT | |
| Relatives | First-degree relatives of patients with diabetes mellitus and normal OGTT | |
| Diabetics | Subjects with abnormal OGTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of vascular function at baseline and during OGTT among the 3 groups.
Differences of pulse wave velocity, augmentation index and central aortic blood pressure at baseline and during OGTT among the 3 groups.
Measured: Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT.
Differences of endothelial function at baseline and during OGTT among the 3 groups.
Differences of coronary flow reserve and endothelial glycocalyx thickness at baseline and during OGTT among the 3 groups.
Measured: Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT.
Secondary outcomes (2)
Insulin resistance and arterial stiffness
Association of insulin resistance with changes of pulse wave velocity, augmentation index and central aortic blood pressure during OGTT
Measured: Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT.
Insulin resistance and endothelial function
Association of insulin resistance with changes of coronary flow reserve and endothelial glycocalyx during OGTT
Measured: Baseline, 30 min, 60 min, 90 min,120 min of OGTT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2014
- Study completionMar 2015
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 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 2 Years
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, GreeceCharalambos Koukoulis, MD, Principal investigator, 2nd Cardiology Department, University of Athens, GreeceFotini Kousathana, MD, Principal investigator, 2nd Department of Internal Medicine, University of Athens, GreeceMaria Varoudi, MD, Principal investigator, 2nd Cardiology Department, University of Athens, GreeceVlasios Tritakis, MD, Principal investigator, 2nd Cardiology Department, University of Athens, GreeceHelen Triantafyllidi, MD, Principal investigator, 2nd Cardiology Department, University of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244736
- Sponsor's protocol ID
- K-DM-ATTIKON
- Status last verified
- Oct 2018
- First submitted
- 15 Sep 2014
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ikonomidis I, Lambadiari V, Pavlidis G, Koukoulis C, Kousathana F, Varoudi M, Spanoudi F, Maratou E, Parissis J, Triantafyllidi H, Paraskevaidis I, Dimitriadis G, Lekakis J. Insulin resistance and acute glucose changes determine arterial elastic properties and coronary flow reserve in dysglycaemic and first-degree relatives of diabetic patients. Atherosclerosis. 2015 Aug;241(2):455-62. doi: 10.1016/j.atherosclerosis.2015.06.006. Epub 2015 Jun 9.
PubMed 26081121
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of the Endothelial Glycocalyx, the Elastic Properties of the Arteries and the Coronary Flow Reserve (CFR) During Oral Glucose Tolerance Test in Patients With New Onset Diabetes Mellitus and First-degree Relatives
- ClinicalTrials.gov ID
- NCT02244736
- Acronym / sponsor ID
- K-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
- Feb 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Sep 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.
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 association between damage of endothelial glycocalyx, impaired arterial elastic properties, and CFR in diabetics and first degree relatives has not been explored. The purpose of this study is to explore the association between damage of endothelial glycocalyx, impaired arterial elastic properties, and CFR in diabetics and first-degree relatives before and after during oral glucose tolerance test (OGTT).
Detailed description
The investigators plan to examine 90 subjects without known diabetes a standard 75-gr oral glucose tolerance test (OGTT) will be performed. [30 first degree relatives of diabetics with normal OGTT (relatives), 30 with normal OGTT and no family history of diabetes (normals), and 30 with abnormal OGTT (diabetics) matched for age and sex].
Plasma glucose and serum insulin levels will be measured in venous blood collected at 0, 30, 60, 90 and 120min after glucose loading. At the same time intervals, the investigators will measure:
- the carotid to femoral pulse wave velocity (PWVc) using the Complior apparatus
- the aortic pulse wave velocity (PWVa), central systolic blood pressure (cSBP) and augmentation index (AI) using an oscillometric method (Arteriograph,TensioMed) as markers of arterial stiffness and wave reflections
- the coronary flow reserve (CFR) at baseline and after adenosine infusion (140 μg × kg-1 × min-1) for 3 minutes to assess coronary vasomotor function
- the perfusion 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 glycocalyx thickness.
In addition, the investigators will measure free fatty acids, triglycerides, glycerol, C reactive protein (CRP), transforming growth factor-b (TGF-b), Lipoprotein-Associated Phospholipase A2, (LP-LPA2), tumor necrosis factor (TNF-a), interleukin 6 (IL6) and interleukin 10 (IL10) propeptide of type I procollagen, (PIP), propeptide of procollagen type III (PIIINP), matrix metallopeptidases 9 and 2 (MMP 9 and 2), macrophage-colony stimulating factor ( MCSF).
The investigators will measure insulin resistance a) after fasting, using homeostatic model assessment (HOMA) and hepatic insulin sensitivity (HIS) b) during oral glucose tolerance test (OGTT) using Matsuda index and insulin sensitivity index (ISI). The investigators will categorize patients in those with normal (<140 mg/dl at 120 min) and those with abnormal OGTT (>200mg/dl at 120min).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –Subjects with no family history of diabetes mellitus and normal OGTT |
| Relatives | – | –First-degree relatives of patients with diabetes mellitus and normal OGTT |
| Diabetics | – | –Subjects with abnormal OGTT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 90 subjects, 30 first degree relatives of diabetics withnormal OGTT (relatives), 30 withnormal OGTT and no family history of diabetes (normals), and 30 with abnormal OGTT (diabetics).
Key inclusion criteria (2 listed)
- subjects without known diabetes
- first degree relatives of diabetics
Key exclusion criteria (5 listed)
- coronary or 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 of vascular function at baseline and during OGTT among the 3 groups.
Time frame: Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT.
Differences of pulse wave velocity, augmentation index and central aortic blood pressure at baseline and during OGTT among the 3 groups.
Differences of endothelial function at baseline and during OGTT among the 3 groups.
Time frame: Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT.
Differences of coronary flow reserve and endothelial glycocalyx thickness at baseline and during OGTT among the 3 groups.
2 secondary outcomes
Insulin resistance and arterial stiffness
Time frame: Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT.
Insulin resistance and endothelial function
Time frame: Baseline, 30 min, 60 min, 90 min,120 min of OGTT
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 4 Mar 2019.
- Derived from this study: PubMed 26081121Ikonomidis I, Lambadiari V, Pavlidis G, Koukoulis C, Kousathana F, Varoudi M, Spanoudi F, Maratou E, Parissis J, Triantafyllidi H, Paraskevaidis I, Dimitriadis G, Lekakis J. Insulin resistance and acute glucose changes determine arterial elastic properties and coronary flow reserve in dysglycaemic and first-degree relatives of diabetic patients. Atherosclerosis. 2015 Aug;241(2):455-62. doi: 10.1016/j.atherosclerosis.2015.06.006. Epub 2015 Jun 9.
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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 2 inclusion and 5 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 4 Mar 2019. 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 of vascular function at baseline and during OGTT among the 3 groups. (time frame: Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT.). The study lists 2 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 NCT02244736, 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 4 Mar 2019.