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Ghrelin and Diastolic Heart Function

Sponsor
University of Campania "Luigi Vanvitelli" (Other)
Overall Status
Completed
CT.gov ID
NCT05988346
Collaborator
(none)
60
Enrollment
1
Location
74
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: abdominal plastic intervention

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Ghrelin Expression Could Regulate Diastolic Heart Function in Obese Patients With Diabetes
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Jan 1, 2022
Actual Study Completion Date :
Mar 1, 2022

Arms and Interventions

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

Procedure: abdominal plastic intervention
According to international guidelines, authors will remove the superficial abdominal fat from the patients enrolled in the study.
T2DM obese patients with first degree of left ventricle (LV) diastolic dysfunction.

Procedure: abdominal plastic intervention
According to international guidelines, authors will remove the superficial abdominal fat from the patients enrolled in the study.
T2DM obese patients with second degree of left ventricle (LV) diastolic dysfunction.

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • T2DM obese patients with anti-diabetic full medical therapy and glycemic control.
Exclusion Criteria:
  • patients with a diagnosis of type 1 diabetes, T2DM 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%); patients with severe anemia, thyroid dysfunction, kidney failure; patients with uncontrolled blood pressure (blood pressure > 140/90 mmHg on two occasions 2 weeks apart), inflammatory chronic disease, and neoplastic disease.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Celestino Sardu Naples Italy 80138

Sponsors and Collaborators

  • University of Campania "Luigi Vanvitelli"

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Celestino Sardu, Professor of Medicine, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier:
NCT05988346
Other Study ID Numbers:
  • 0408052023
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Obesity, Abdominal

Study Results

No Results Posted as of Aug 14, 2023