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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Dulaglutide
* Drug: Aspart insulin
* Drug: Glargine
* Drug: Metformin
* Drug: Repaglinide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diabetes mellitus Exclusion Criteria: cancer, severe ckd, end stage liver disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, dulaglutide, endothelial function