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Completed

NCT Number: NCT03824002

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

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Internal Medicine Ward, University of Palermo

Palermo, 90127, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diabetes mellitus

Exclusion criteria

  • cancer, severe ckd, end stage liver disease

Treatment and study plan

Dulaglutide

Drug

Diabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides

Other names: aspart insulin, glargine insulin, metformin, repaglinide

Aspart insulin

Drug

Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide

Glargine

Drug

Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide

metformin

Drug

Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide

repaglinide

Drug

Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide

Primary outcomes

  1. Change from Baseline Reactive Hyperemia Index at 3 and 9 months

    Time frame: 0 months, 3 months and 9 months

    Endothelial function index RHI

Secondary outcomes

  1. Change from Baseline systolic blood pressure at 3 and 9 months

    Time frame: 0 months, 3 months and 9 months

    systolic blood pressure in mmHg

  2. Change from Baseline Body Mass Index at 3 and 9 months

    Time frame: 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

    Time frame: 0 months, 3 months and 9 months

    blood cholesterol in mg/dl

  4. Change from Baseline triglycerides at 3 and 9 months

    Time frame: 0 months, 3 months and 9 months

    blood triglycerides in mg/dl

  5. Change from Baseline glucose at 3 and 9 months

    Time frame: 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

    Time frame: 0 months, 3 months and 9 months

    diastolic blood pressure in mmHg

  7. Change from Baseline Pulse Wave Velocity at 3 and 9 months

    Time frame: 0 months, 3 months and 9 months

    Pulse Wave Velocity in m/s

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jan 31, 2019
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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