Ghrelin and Diastolic Heart Function

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Ghrelin Expression Could Regulate Diastolic Heart Function in Obese Patients With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05988346
• Other study ID #: 0408052023
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: March 1, 2022

Study information

• Verified date: August 2023
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In type 2 diabetes mellitus (T2DM) and obese patients the adipose tissue could over-express cytokines, sirtuin-1 (SIRT1), and microRNAs (miRs) implied in the regulation of left ventricle (LV) diastolic function (LV-DF). Ghrelin could modulate these pathways. Thus, in the current study authors will investigate ghrelin expression in T2DM obese patients after abdominal fat excision, and particularly in those with normalization of LV-DF at 1 year of follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of T2DM obese patients;

• T2DM obese patients under anti-diabetic full medical therapy and glycemic control.

Exclusion Criteria:

• clinical diagnosis of type 1 diabetes;

• T2DM patients in poor glycemic control (HbA1c values of >7%);

• chronic neurological disorders;

• heart failure and coronary heart disease or depression of left ventricular ejection fraction (LVEF <55%);

• severe anemia;

• thyroid dysfunction;

• kidney failure;

• uncontrolled blood pressure (blood pressure > 140/90 mmHg on two occasions 2 weeks apart);

• inflammatory chronic disease;

• neoplastic disease.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diastolic Dysfunction
• Obesity, Abdominal

Intervention

Procedure:
• abdominal plastic intervention
According to international guidelines, authors will remove the superficial abdominal fat from the patients enrolled in the study.

Locations

Country	Name	City	State
Italy	Celestino Sardu	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	normalization of LV diastolic dysfunction	At 1 year of follow-up authors evaluated the patients (those with first and second degree of LV diastolic dysfunction) that will experience the normalization of LV diastolic function.	12 months