Ghrelin and Diastolic Heart Function

NCT ID: NCT05988346

Last Updated: 2023-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2022-03-01

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2 Obesity, Abdominal Diastolic Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

abdominal plastic intervention

Intervention Type PROCEDURE

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.

abdominal plastic intervention

Intervention Type PROCEDURE

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.

abdominal plastic intervention

Intervention Type PROCEDURE

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

Interventions

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abdominal plastic intervention

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Celestino Sardu

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Celestino Sardu

Naples, , Italy

Site Status

Countries

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Italy

References

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Sardu C, D'Onofrio N, Trotta MC, Balestrieri ML, Nicoletti GF, D'Amico G, Fumagalli C, Contaldi C, Pacileo G, Scisciola L, Nicoletti M, Marfella LV, Sbriscia M, Sasso FC, Signoriello G, Paolisso G, Marfella R. Could Ghrelin Expression Regulate Diastolic Cardiac Function in Type 2 Diabetic Obese Patients? Diabetes Metab Res Rev. 2025 May;41(4):e70049. doi: 10.1002/dmrr.70049.

Reference Type DERIVED
PMID: 40323144 (View on PubMed)

Other Identifiers

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0408052023

Identifier Type: -

Identifier Source: org_study_id

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