Clinical trial NCT05360537: Effects of Degludec/Liraglutide on Time in Range, Inflammation and Endothelial Function vs Insulin Basal Bolus in Diabetic Inpatients
Official title: Effects of Degludec/Liraglutide on Time in Range, 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Insulin Degludec/Liraglutide
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the effects of Insulin Degludec/Liraglutide on glycemic variability assessed by continuous glycemic monitoring with the function time in range, 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: 100 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 2024. 50 patients were treated with Insulin Degludec/Liraglutide, 50 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 glycemic variability was assessed by continuous glycemic monitoring with the analysis of Time in Range

The digital endothelial function was evaluated through the RHI-pat analysis using Endo-PAT2000.

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

Primary outcomes:
measure: Change of Time in Range % at 7 days, at 1 and 6 months
timeFrame: 7 days, 1 months and 6 months
measure: Change of hypoglycemic events
timeFrame: 7 days, 1 months and 6 months
measure: Change from Baseline Reactive Hyperemia Index at 3 and 9 months
timeFrame: 7 days, 1 months and 6 months
Secondary outcomes:
measure: Change from Baseline serum of C- Reactive-Protein (CRP)
timeFrame: 7 days, 1 months and 6 months
measure: Change from Baseline serum levels of Interleukin-6 (IL6)
timeFrame: 7 days, 1 months and 6 months
measure: Change from Baseline serum levels of ferritin
timeFrame: 7 days, 1 months and 6 months
measure: Change of intra and extra-hospital mortality
timeFrame: 7 days, 1 months and 6 months
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Internal Medicine Ward, University of Palermo
Study officials:
affiliation: University of Palermo
name: Antonino Tuttolomondo, Professor
role: STUDY_DIRECTOR
References: