Dulaglutide in Diabetic Patients, Relationship Between Arterial Stiffness, Endothelial Function, Clinical and Laboratory Variables

Diabetes Mellitus Clinical Trial

Official title:

Arterial Stiffness and Endothelial Function Indexes, Relationships With Clinical and Laboratory Variables in a Group of Diabetic Patients in Treatment With Dulaglutide: a Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824002
• Other study ID #: 21772
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2017
• Est. completion date: April 20, 2018

Study information

• Verified date: January 2019
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to evaluate arterial stiffness and endothelial function indexes and their relationship with clinic and laboratory varible in a group of diabetic patients in treatment with dulaglutide

Description:

46 patients with type 2 diabetes mellitus were recruited at the Internal Medicine with Stroke care ward of the University hospital of Palermo "P. Giaccone" from April 2017 to April 2018. For all patients treatment with dulaglutide was undertaken. As control group were recruited 46 patients from the same ward not affected by diabetes mellitus or affected by diabetes mellitus but not in treatment with dulaglutide.

The study was carried out in accordance with the principles of the Helsinki Declaration revised in 2001 and all patients gave their written consent to take part in this research.

Each patient treated with dulaglutide was compared for age, sex and cardiovascular risk with control patients. The diagnosis of type 2 diabetes mellitus was based on the revised criteria of the American Diabetes Association (ADA), and using a clinical algorithm that considered the age of onset of the disease, the symptoms and weight present, the family history and the therapy practiced. Arterial hypertension was defined according to the 2017 ESC-ESH criteria. Dyslipidemia was defined based on total cholesterol levels> 200 mg/dl, triglycerides> 150 mg/dl and HDL levels <40 mg/dl regardless of the patient's gender.

Among the cases enrolled, 46 (100%) had type 2 diabetes mellitus, 37 (80.43%) had arterial hypertension and 26 (56.52%) hypercholesterolemia.

Clinical and anthropometric data were collected at the time of recruitment. Blood samples were taken from each patient (cases and controls) to determine serum glucose, HbA1c, total cholesterol, HDL and LDL cholesterol, triglycerides, creatinine, and a urine sample to assess the presence of microalbuminuria. These withdrawals were then repeated three months and nine months from the time of recruitment.

The digital endothelial function was evaluated through the RHI-pat analysis using Endo-PAT2000. Pulse Wave Velocity (PWV) Carotid-Femoral Pulse was measured in the supine position using an automatic device (SphygmoCor version 7.1) that evaluated the propagation time of the sphygmic wave between the carotid and femoral pulse.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 20, 2018
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• diabetes mellitus

Exclusion Criteria:

• cancer, severe ckd, end stage liver disease

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Dulaglutide
Diabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides
• Aspart insulin
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
• Glargine
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
• Metformin
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
• Repaglinide
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide

Locations

Country	Name	City	State
Italy	Internal Medicine Ward, University of Palermo	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Reactive Hyperemia Index at 3 and 9 months	Endothelial function index RHI	0 months, 3 months and 9 months
Secondary	Change from Baseline systolic blood pressure at 3 and 9 months	systolic blood pressure in mmHg	0 months, 3 months and 9 months
Secondary	Change from Baseline Body Mass Index at 3 and 9 months	weight and height will be combined to report BMI in kg/m^2	0 months, 3 months and 9 months
Secondary	Change from Baseline cholesterol at 3 and 9 months	blood cholesterol in mg/dl	0 months, 3 months and 9 months
Secondary	Change from Baseline triglycerides at 3 and 9 months	blood triglycerides in mg/dl	0 months, 3 months and 9 months
Secondary	Change from Baseline glucose at 3 and 9 months	fasting blood glucose in mg/dl	0 months, 3 months and 9 months
Secondary	Change from Baseline diastolic blood pressure at 3 and 9 months	diastolic blood pressure in mmHg	0 months, 3 months and 9 months
Secondary	Change from Baseline Pulse Wave Velocity at 3 and 9 months	Pulse Wave Velocity in m/s	0 months, 3 months and 9 months