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

University of Palermo

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: Metformin; Drug: Dulaglutide; Drug: Repaglinide; Drug: Aspart insulin; Drug: Glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT03824002

21772

Details and patient eligibility

About

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

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• diabetes mellitus

Exclusion criteria

• cancer, severe ckd, end stage liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups

patients treated with dulaglutide

Experimental group

Description:

Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide

Treatment:

Drug: Glargine

Drug: Metformin

Drug: Aspart insulin

Drug: Repaglinide

Drug: Dulaglutide

patients not treated with dulaglutide

Active Comparator group

Description:

Diabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide

Treatment:

Drug: Glargine

Drug: Metformin

Drug: Aspart insulin

Drug: Repaglinide