Vascular Markers During OGTT in Diabetics and First-degree Relatives

NCT ID: NCT02244736

Last Updated: 2019-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-03-31

Brief 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. 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:

1. the carotid to femoral pulse wave velocity (PWVc) using the Complior apparatus

2. 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

3. 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

4. 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Controls

Subjects with no family history of diabetes mellitus and normal OGTT

No interventions assigned to this group

Relatives

First-degree relatives of patients with diabetes mellitus and normal OGTT

No interventions assigned to this group

Diabetics

Subjects with abnormal OGTT

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• subjects without known diabetes
• first degree relatives of diabetics

Exclusion Criteria

• coronary or valvular heart disease
• congestive heart failure
• peripheral vascular disease
• liver or kidney failure
• history of alcohol or drug abuse

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Ignatios Ikonomidis

Assistant Professor in Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ignatios Ikonomidis, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Cardiology Department, University of Athens, Greece

George Pavlidis, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Cardiology Department, University of Athens, Greece

Vaia Lambadiari, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Department of Internal Medicine , University of Athens, Greece

Charalambos Koukoulis, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Cardiology Department, University of Athens, Greece

Fotini Kousathana, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Department of Internal Medicine, University of Athens, Greece

Maria Varoudi, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Cardiology Department, University of Athens, Greece

Vlasios Tritakis, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Cardiology Department, University of Athens, Greece

Helen Triantafyllidi, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Cardiology Department, University of Athens, Greece

George Dimitriadis, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Department of Internal Medicine, University of Athens, Greece

John Lekakis, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Cardiology Department, University of Athens, Greece

Locations

''Attikon'' University General Hospital

Athens, Attica, Greece

Countries

Greece

References

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.

Reference Type: DERIVED

PMID: 26081121 (View on PubMed)

Other Identifiers

K-DM-ATTIKON

Identifier Type: -

Identifier Source: org_study_id