Ghrelin and Diastolic Heart Function

University of Campania "Luigi Vanvitelli"

Status: Completed

Conditions: Diastolic Dysfunction; Obesity, Abdominal; Diabetes Mellitus, Type 2

Treatments: Procedure: abdominal plastic intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05988346

0408052023

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 3 patient groups

type 2 diabetes mellitus (T2DM) obese patients without left ventricle (LV) diastolic dysfunction.

Treatment:

Procedure: abdominal plastic intervention

T2DM obese patients with first degree of left ventricle (LV) diastolic dysfunction.

Treatment:

Procedure: abdominal plastic intervention

T2DM obese patients with second degree of left ventricle (LV) diastolic dysfunction.

Treatment:

Procedure: abdominal plastic intervention