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Effects of Liraglutide on Glycemia, Inflammation and Endothelial Function vs Insulin Basal Bolus in Diabetic Inpatients

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Liraglutide injection
Insulin Glargine
Sponsored by
University of Palermo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring liraglutide

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diabetes mellitus type 2
  • Mild-moderate Hyperglycemia (180-400 mg/dl)
  • Acute events (Pneumonia, Acute cardiac Ischemia, Ictus, IVU)

Exclusion Criteria:

  • Diabetes mellitus type 1
  • Diabetic ketoacidosis
  • Hyperosmolar coma
  • Severe hypoglycaemia
  • Acute Pancreatitis
  • Cancer
  • use of corticosteroids
  • pregnancy
  • Chronic kidney disease (< 30 ml/min) or hemodialysis

Sites / Locations

  • Internal Medicine Ward, University of Palermo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

patients treated with liraglutide

patients treated with liraglutide plus Basal Insulin

patients treated with Insulin regime Basal Bolus

Arm Description

Diabetes therapy with liraglutide and various combinations of metformin, repaglinide, sulfonylureas.

Diabetes therapy with liraglutide and various combinations of glargine insulin, metformin, repaglinide, sulfonylureas.

Diabetes therapy with the combination of a single administration of glargine insulin and three administration of Aspart Insulin.

Outcomes

Primary Outcome Measures

Change of average glycemia (mg/dl) at 3 and 6 months
Blodd sampling for the valutation of average glycemia (mg/dl)
Change of hypoglycemic events
Change of hypoglycemic events (symptoms and serum glycemia < 60 mg/dl)
Change from Baseline Reactive Hyperemia Index at 3 and 9 months
Change of Endothelial function by the use of Endopat2000 with the evaluation of Reactive Hypereremia Index (normal value of RHI > 1,27)

Secondary Outcome Measures

Change from Baseline serum of C- Reactive-Protein (CRP)
Variation from baseline serum levels of C- Reactive-Protein (CRP) (mg/dl)
Change from Baseline serum levels of Interleukin-6 (IL6)
Variation from baseline serum levels of Interleukin-6 (IL6) (pg/ml)
Change from Baseline serum levels of ferritin
Variation from baseline serum levels of ferritin (mcg/L)
Change of intra and extra-hospital mortality
Change of intra and extra-hospital mortality

Full Information

First Posted
April 20, 2022
Last Updated
May 3, 2022
Sponsor
University of Palermo
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1. Study Identification

Unique Protocol Identification Number
NCT05360537
Brief Title
Effects of Liraglutide on Glycemia, Inflammation and Endothelial Function vs Insulin Basal Bolus in Diabetic Inpatients
Official Title
Effects of Liraglutide on Glycemic Control, Markers of Inflammation and Endothelial Dysfunction Compared to Scheme Insulin Basal Bolus, in a Population of Diabetic Inpatients and Possible Correlation With Intra-hospital Mortality Rates
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
April 20, 2022 (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

5. Study Description

Brief Summary
The study aims to evaluate the effects of Liraglutide on glycemic control, serum markers of inflammation, markers of endothelial dysfunction and a possible correlation with intra and extra-hospital mortality rates in a group of hospitalized diabetic patients compared to a control group of in-patient diabetic in treatment on insulin Basal-bolus.
Detailed Description
135 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 2022 to April 2023. 45 patients were treated with liraglutide, 45 were treated with liraglutide plus Basal Insulin and 45 were undertaken treatment regime with Insulin Basal Bolus (control group). 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 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, 135 (100%) had type 2 diabetes mellitus, 110 (80 %) had arterial hypertension and 74 (55%) 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, CRP, Ferritin, IL-6. These withdrawals were then repeated three months and six months from the time of recruitment. The digital endothelial function was evaluated through the RHI-pat analysis using Endo-PAT2000.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
liraglutide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Double (Participant, Care Provider)
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients treated with liraglutide
Arm Type
Experimental
Arm Description
Diabetes therapy with liraglutide and various combinations of metformin, repaglinide, sulfonylureas.
Arm Title
patients treated with liraglutide plus Basal Insulin
Arm Type
Experimental
Arm Description
Diabetes therapy with liraglutide and various combinations of glargine insulin, metformin, repaglinide, sulfonylureas.
Arm Title
patients treated with Insulin regime Basal Bolus
Arm Type
Active Comparator
Arm Description
Diabetes therapy with the combination of a single administration of glargine insulin and three administration of Aspart Insulin.
Intervention Type
Drug
Intervention Name(s)
Liraglutide injection
Other Intervention Name(s)
Liraglutide
Intervention Description
administration of liraglutide
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Other Intervention Name(s)
glargine
Intervention Description
Administration of glargine insulin
Primary Outcome Measure Information:
Title
Change of average glycemia (mg/dl) at 3 and 6 months
Description
Blodd sampling for the valutation of average glycemia (mg/dl)
Time Frame
0 months, 3 months and 6 months
Title
Change of hypoglycemic events
Description
Change of hypoglycemic events (symptoms and serum glycemia < 60 mg/dl)
Time Frame
0 months, 3 months and 6 months
Title
Change from Baseline Reactive Hyperemia Index at 3 and 9 months
Description
Change of Endothelial function by the use of Endopat2000 with the evaluation of Reactive Hypereremia Index (normal value of RHI > 1,27)
Time Frame
0 months, 3 months and 6 months
Secondary Outcome Measure Information:
Title
Change from Baseline serum of C- Reactive-Protein (CRP)
Description
Variation from baseline serum levels of C- Reactive-Protein (CRP) (mg/dl)
Time Frame
0 months, 3 months and 6 months
Title
Change from Baseline serum levels of Interleukin-6 (IL6)
Description
Variation from baseline serum levels of Interleukin-6 (IL6) (pg/ml)
Time Frame
0 months, 3 months and 6 months
Title
Change from Baseline serum levels of ferritin
Description
Variation from baseline serum levels of ferritin (mcg/L)
Time Frame
0 months, 3 months and 6 months
Title
Change of intra and extra-hospital mortality
Description
Change of intra and extra-hospital mortality
Time Frame
0 months, 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetes mellitus type 2 Mild-moderate Hyperglycemia (180-400 mg/dl) Acute events (Pneumonia, Acute cardiac Ischemia, Ictus, IVU) Exclusion Criteria: Diabetes mellitus type 1 Diabetic ketoacidosis Hyperosmolar coma Severe hypoglycaemia Acute Pancreatitis Cancer use of corticosteroids pregnancy Chronic kidney disease (< 30 ml/min) or hemodialysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonino Tuttolomondo, Professor
Organizational Affiliation
University of Palermo
Official's Role
Study Director
Facility Information:
Facility Name
Internal Medicine Ward, University of Palermo
City
Palermo
ZIP/Postal Code
90127
Country
Italy

12. IPD Sharing Statement

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Effects of Liraglutide on Glycemia, Inflammation and Endothelial Function vs Insulin Basal Bolus in Diabetic Inpatients

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