Ghrelin and Diastolic Heart Function

Completed

• Conditions: Diabetes Mellitus, Type 2; Obesity, Abdominal; Diastolic Dysfunction
• Interventions: Procedure: abdominal plastic intervention

• Registration Number: NCT05988346
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-03-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-04
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-14
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T2DM obese patients with first degree of left ventricle (LV) diastolic dysfunction.	abdominal plastic intervention	-
T2DM obese patients with second degree of left ventricle (LV) diastolic dysfunction.	abdominal plastic intervention	-
type 2 diabetes mellitus (T2DM) obese patients without left ventricle (LV) diastolic dysfunction.	abdominal plastic intervention	-

Primary Outcome Measures

Name	Time	Method
normalization of LV diastolic dysfunction	12 months	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.

Trial Locations

Locations (1)

Celestino Sardu; 🇮🇹 Naples, Italy