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Completed

NCT Number: NCT02244736

Vascular Markers During OGTT in Diabetics 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).

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

''Attikon'' University General Hospital

Athens, Attica, 12462, Greece

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Insulin resistance and arterial stiffness

    Time frame: Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT.

    Association of insulin resistance with changes of pulse wave velocity, augmentation index and central aortic blood pressure during OGTT

  2. Insulin resistance and endothelial function

    Time frame: Baseline, 30 min, 60 min, 90 min,120 min of OGTT

    Association of insulin resistance with changes of coronary flow reserve and endothelial glycocalyx during OGTT

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Sep 19, 2014
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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