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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Dulaglutide; Drug: Aspart insulin; Drug: Glargine; Drug: Metformin; Drug: Repaglinide

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Palermo, Italy, 90127
    • Internal Medicine Ward, University of Palermo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diabetes mellitus

Exclusion Criteria:

• cancer, severe ckd, end stage liver disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients treated with dulaglutide; Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide	Drug: Dulaglutide; Diabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides; Other Names: metformin; aspart insulin; glargine insulin; repaglinide; Drug: Aspart insulin; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide; Drug: Glargine; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide; Drug: Metformin; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide; Drug: Repaglinide; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Active Comparator: patients not treated with dulaglutide; Diabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide	Drug: Aspart insulin; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide; Drug: Glargine; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide; Drug: Metformin; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide; Drug: Repaglinide; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Reactive Hyperemia Index at 3 and 9 months	Endothelial function index RHI	0 months, 3 months and 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline systolic blood pressure at 3 and 9 months	systolic blood pressure in mmHg	0 months, 3 months and 9 months
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
Change from Baseline cholesterol at 3 and 9 months	blood cholesterol in mg/dl	0 months, 3 months and 9 months
Change from Baseline triglycerides at 3 and 9 months	blood triglycerides in mg/dl	0 months, 3 months and 9 months
Change from Baseline glucose at 3 and 9 months	fasting blood glucose in mg/dl	0 months, 3 months and 9 months
Change from Baseline diastolic blood pressure at 3 and 9 months	diastolic blood pressure in mmHg	0 months, 3 months and 9 months
Change from Baseline Pulse Wave Velocity at 3 and 9 months	Pulse Wave Velocity in m/s	0 months, 3 months and 9 months

Collaborators and Investigators

• Sponsor: University of Palermo

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): April 20, 2018

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: diabetes mellitus; endothelial function; dulaglutide
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Dulaglutide; Metformin; Insulin Glargine; Repaglinide
• Other Study ID Numbers: 21772

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No