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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03824002
Enrollment
92
Registered
2019-01-31
Start date
2017-04-01
Completion date
2018-04-20
Last updated
2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

diabetes mellitus, dulaglutide, endothelial function

Brief 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

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.

Interventions

DRUGDulaglutide

Diabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides

Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide

DRUGGlargine

Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide

DRUGMetformin

Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide

DRUGRepaglinide

Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide

Sponsors

University of Palermo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* diabetes mellitus

Exclusion criteria

* cancer, severe ckd, end stage liver disease

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Reactive Hyperemia Index at 3 and 9 months0 months, 3 months and 9 monthsEndothelial function index RHI

Secondary

MeasureTime frameDescription
Change from Baseline Body Mass Index at 3 and 9 months0 months, 3 months and 9 monthsweight and height will be combined to report BMI in kg/m\^2
Change from Baseline cholesterol at 3 and 9 months0 months, 3 months and 9 monthsblood cholesterol in mg/dl
Change from Baseline triglycerides at 3 and 9 months0 months, 3 months and 9 monthsblood triglycerides in mg/dl
Change from Baseline systolic blood pressure at 3 and 9 months0 months, 3 months and 9 monthssystolic blood pressure in mmHg
Change from Baseline diastolic blood pressure at 3 and 9 months0 months, 3 months and 9 monthsdiastolic blood pressure in mmHg
Change from Baseline Pulse Wave Velocity at 3 and 9 months0 months, 3 months and 9 monthsPulse Wave Velocity in m/s
Change from Baseline glucose at 3 and 9 months0 months, 3 months and 9 monthsfasting blood glucose in mg/dl

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026