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

• Sponsor: University of Palermo (Other)
• Overall Status: Completed
• CT.gov ID: NCT03824002
• Collaborator: (none)
• Enrollment: 92
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.6
• Patients Per Site Per Month: 7.3

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: Dulaglutide; Drug: Aspart insulin; Drug: Glargine; Drug: Metformin; Drug: Repaglinide	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 1, 2017
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Apr 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patients treated with dulaglutide Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide	Drug: Dulaglutide; Diabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides; Other Names: aspart insulin glargine insulin metformin repaglinide ; Drug: Aspart insulin; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide; Drug: Glargine; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide; Drug: Metformin; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide; Drug: Repaglinide; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
Active Comparator: patients not treated with dulaglutide Diabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide	Drug: Aspart insulin; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide; Drug: Glargine; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide; Drug: Metformin; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide; Drug: Repaglinide; Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide

Outcome Measures

Primary Outcome Measures

1. Change from Baseline Reactive Hyperemia Index at 3 and 9 months [0 months, 3 months and 9 months]

   Endothelial function index RHI

Secondary Outcome Measures

1. Change from Baseline systolic blood pressure at 3 and 9 months [0 months, 3 months and 9 months]

   systolic blood pressure in mmHg

2. Change from Baseline Body Mass Index at 3 and 9 months [0 months, 3 months and 9 months]

   weight and height will be combined to report BMI in kg/m^2

3. Change from Baseline cholesterol at 3 and 9 months [0 months, 3 months and 9 months]

   blood cholesterol in mg/dl

4. Change from Baseline triglycerides at 3 and 9 months [0 months, 3 months and 9 months]

   blood triglycerides in mg/dl

5. Change from Baseline glucose at 3 and 9 months [0 months, 3 months and 9 months]

   fasting blood glucose in mg/dl

6. Change from Baseline diastolic blood pressure at 3 and 9 months [0 months, 3 months and 9 months]

   diastolic blood pressure in mmHg

7. Change from Baseline Pulse Wave Velocity at 3 and 9 months [0 months, 3 months and 9 months]

   Pulse Wave Velocity in m/s

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• diabetes mellitus

Exclusion Criteria:

• cancer, severe ckd, end stage liver disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Internal Medicine Ward, University of Palermo	Palermo		Italy	90127

Sponsors and Collaborators

• University of Palermo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antonino Tuttolomondo, University professor, University of Palermo
• ClinicalTrials.gov Identifier: NCT03824002
• Other Study ID Numbers: 21772
• First Posted: Jan 31, 2019
• Last Update Posted: Jan 31, 2019
• Last Verified: Jan 1, 2019

• 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
• Keywords provided by Antonino Tuttolomondo, University professor, University of Palermo: diabetes mellitus; dulaglutide; endothelial function
• Additional relevant MeSH terms: Diabetes Mellitus; Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Insulin Aspart; Dulaglutide; Repaglinide; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination

Study Results

No Results Posted as of Jan 31, 2019