Dulaglutide in Diabetic Patients, Relationship Between Arterial Stiffness, Endothelial Function, Clinical and Laboratory Variables
Primary Purpose
Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Dulaglutide
Aspart insulin
Glargine
Metformin
Repaglinide
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring diabetes mellitus, dulaglutide, endothelial function
Eligibility Criteria
Inclusion Criteria:
- diabetes mellitus
Exclusion Criteria:
- cancer, severe ckd, end stage liver disease
Sites / Locations
- Internal Medicine Ward, University of Palermo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
patients treated with dulaglutide
patients not treated with dulaglutide
Arm Description
Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide
Diabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide
Outcomes
Primary Outcome Measures
Change from Baseline Reactive Hyperemia Index at 3 and 9 months
Endothelial function index RHI
Secondary Outcome Measures
Change from Baseline systolic blood pressure at 3 and 9 months
systolic blood pressure in mmHg
Change from Baseline Body Mass Index at 3 and 9 months
weight and height will be combined to report BMI in kg/m^2
Change from Baseline cholesterol at 3 and 9 months
blood cholesterol in mg/dl
Change from Baseline triglycerides at 3 and 9 months
blood triglycerides in mg/dl
Change from Baseline glucose at 3 and 9 months
fasting blood glucose in mg/dl
Change from Baseline diastolic blood pressure at 3 and 9 months
diastolic blood pressure in mmHg
Change from Baseline Pulse Wave Velocity at 3 and 9 months
Pulse Wave Velocity in m/s
Full Information
NCT ID
NCT03824002
First Posted
December 6, 2018
Last Updated
January 29, 2019
Sponsor
University of Palermo
1. Study Identification
Unique Protocol Identification Number
NCT03824002
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
April 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Palermo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
diabetes mellitus, dulaglutide, endothelial function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients treated with dulaglutide
Arm Type
Experimental
Arm Description
Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide
Arm Title
patients not treated with dulaglutide
Arm Type
Active Comparator
Arm Description
Diabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide
Intervention Type
Drug
Intervention Name(s)
Dulaglutide
Other Intervention Name(s)
aspart insulin, glargine insulin, metformin, repaglinide
Intervention Description
Diabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides
Intervention Type
Drug
Intervention Name(s)
Aspart insulin
Intervention Description
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Intervention Type
Drug
Intervention Name(s)
Glargine
Intervention Description
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Intervention Type
Drug
Intervention Name(s)
Repaglinide
Intervention Description
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Primary Outcome Measure Information:
Title
Change from Baseline Reactive Hyperemia Index at 3 and 9 months
Description
Endothelial function index RHI
Time Frame
0 months, 3 months and 9 months
Secondary Outcome Measure Information:
Title
Change from Baseline systolic blood pressure at 3 and 9 months
Description
systolic blood pressure in mmHg
Time Frame
0 months, 3 months and 9 months
Title
Change from Baseline Body Mass Index at 3 and 9 months
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
0 months, 3 months and 9 months
Title
Change from Baseline cholesterol at 3 and 9 months
Description
blood cholesterol in mg/dl
Time Frame
0 months, 3 months and 9 months
Title
Change from Baseline triglycerides at 3 and 9 months
Description
blood triglycerides in mg/dl
Time Frame
0 months, 3 months and 9 months
Title
Change from Baseline glucose at 3 and 9 months
Description
fasting blood glucose in mg/dl
Time Frame
0 months, 3 months and 9 months
Title
Change from Baseline diastolic blood pressure at 3 and 9 months
Description
diastolic blood pressure in mmHg
Time Frame
0 months, 3 months and 9 months
Title
Change from Baseline Pulse Wave Velocity at 3 and 9 months
Description
Pulse Wave Velocity in m/s
Time Frame
0 months, 3 months and 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
diabetes mellitus
Exclusion Criteria:
cancer, severe ckd, end stage liver disease
Facility Information:
Facility Name
Internal Medicine Ward, University of Palermo
City
Palermo
ZIP/Postal Code
90127
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Dulaglutide in Diabetic Patients, Relationship Between Arterial Stiffness, Endothelial Function, Clinical and Laboratory Variables
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