Vascular Markers During OGTT in Diabetics and First-degree Relatives

NCT02244736 | Completed DMC

• 1 other identifier: K-DM-ATTIKON
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus

Keywords

Arterial stiffness; Endothelial glycocalyx; Coronary flow reserve

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT.

Secondary Outcomes (2)

• Insulin resistance and arterial stiffness

  Baseline, 30 min, 60 min, 90 min, and 120 min during OGTT.

• Insulin resistance and endothelial function

  Baseline, 30 min, 60 min, 90 min,120 min of OGTT

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• subjects without known diabetes
• first degree relatives of diabetics

You may not qualify if:

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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

''Attikon'' University General Hospital

Athens, Attica, 12462, Greece

Location

Related Publications (1)

• 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.

  PMID: 26081121 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma in serum for fibrosis and inflammatory markers

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ignatios Ikonomidis, MD

  2nd Cardiology Department, University of Athens, Greece

  PRINCIPAL INVESTIGATOR

• George Pavlidis, MD

  2nd Cardiology Department, University of Athens, Greece

  PRINCIPAL INVESTIGATOR

• Vaia Lambadiari, MD

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

  PRINCIPAL INVESTIGATOR

• Charalambos Koukoulis, MD

  2nd Cardiology Department, University of Athens, Greece

  PRINCIPAL INVESTIGATOR

• Fotini Kousathana, MD

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

  PRINCIPAL INVESTIGATOR

• Maria Varoudi, MD

  2nd Cardiology Department, University of Athens, Greece

  PRINCIPAL INVESTIGATOR

• Vlasios Tritakis, MD

  2nd Cardiology Department, University of Athens, Greece

  PRINCIPAL INVESTIGATOR

• Helen Triantafyllidi, MD

  2nd Cardiology Department, University of Athens, Greece

  PRINCIPAL INVESTIGATOR

• George Dimitriadis, MD

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

  PRINCIPAL INVESTIGATOR

• John Lekakis, MD

  2nd Cardiology Department, University of Athens, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Cardiology

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 19, 2014
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: March 4, 2019

Record last verified: 2018-10

Locations

GR (1)