Dulaglutide in Diabetic Patients, Relationship Between Arterial Stiffness, Endothelial Function, Clinical and Laboratory Variables
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Dulaglutide; Aspart insulin; Glargine; Metformin; Repaglinide
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Diabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Other intervention name(s): aspart insulin; glargine insulin; metformin; repaglinide
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Insulin Aspart; Dulaglutide; Repaglinide; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: diabetes mellitus; dulaglutide; endothelial function