Dulaglutide in Diabetic Patients, Relationship Between Arterial Stiffness, Endothelial Function, Clinical and Laboratory Variables
NCT ID: NCT03824002
Last Updated: 2019-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
92 participants
INTERVENTIONAL
2017-04-01
2018-04-20
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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patients treated with dulaglutide
Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide
Dulaglutide
Diabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides
Aspart insulin
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Glargine
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Metformin
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Repaglinide
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
patients not treated with dulaglutide
Diabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide
Aspart insulin
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Glargine
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Metformin
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Repaglinide
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Interventions
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Dulaglutide
Diabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides
Aspart insulin
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Glargine
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Metformin
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Repaglinide
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
Yes
Sponsors
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University of Palermo
OTHER
Responsible Party
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Antonino Tuttolomondo
University professor
Locations
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Internal Medicine Ward, University of Palermo
Palermo, , Italy
Countries
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References
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Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
Other Identifiers
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21772
Identifier Type: -
Identifier Source: org_study_id