Changes in Arterial Stiffness and Endothelial Glycocalyx in Patients With Poorly Controlled Diabetes Mellitus Type 1 or Type 2 After Optimization of Antidiabetic Medication.

NCT03010956 | Completed DMC

• 1 other identifier: S-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 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.

Conditions

Diabetes Mellitus

Keywords

Arterial stiffness; Endothelial glycocalyx; Coronary flow reserve

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, 3 months, 6 months, and 12 months.

Secondary Outcomes (2)

• Endothelial glycocalyx and pulse wave velocity.

  Baseline, 3 months, 6 months, and 12 months.

• Endothelial glycocalyx and coronary flow reserve.

  Baseline, 3 months, 6 months, and 12 months.

Study Arms (2)

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

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

The study population will consist of 30 patients with uncontrolled type 1 diabetes and 30 patients with uncontrolled type 2 diabetes.

You may qualify if:

• Patients with uncontrolled diabetes mellitus

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

''Attikon'' University General Hospital

Athens, Attica, 12462, Greece

Location

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

• Fotini Kousathana, MD

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

  PRINCIPAL INVESTIGATOR

• Constantinos Tymbas, 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 CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Cardiology

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 5, 2017
• Study Start: November 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)