Clinical trial NCT03824002: Dulaglutide in Diabetic Patients, Relationship Between Arterial Stiffness, Endothelial Function, Clinical and Laboratory Variables
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus
dulaglutide
endothelial function
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* diabetes mellitus

Exclusion Criteria:

* cancer, severe ckd, end stage liver disease

Primary outcomes:
measure: Change from Baseline Reactive Hyperemia Index at 3 and 9 months
timeFrame: 0 months, 3 months and 9 months
Secondary outcomes:
measure: Change from Baseline systolic blood pressure at 3 and 9 months
timeFrame: 0 months, 3 months and 9 months
measure: Change from Baseline Body Mass Index at 3 and 9 months
timeFrame: 0 months, 3 months and 9 months
measure: Change from Baseline cholesterol at 3 and 9 months
timeFrame: 0 months, 3 months and 9 months
measure: Change from Baseline triglycerides at 3 and 9 months
timeFrame: 0 months, 3 months and 9 months
measure: Change from Baseline glucose at 3 and 9 months
timeFrame: 0 months, 3 months and 9 months
measure: Change from Baseline diastolic blood pressure at 3 and 9 months
timeFrame: 0 months, 3 months and 9 months
measure: Change from Baseline Pulse Wave Velocity at 3 and 9 months
timeFrame: 0 months, 3 months and 9 months
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Internal Medicine Ward, University of Palermo
Study officials:
References: