Ghrelin and Diastolic Heart Function

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Obesity, Abdominal; Diastolic Dysfunction
• Intervention / Treatment: Procedure: abdominal plastic intervention

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80138
    • Celestino Sardu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The authors will enroll T2DM obese patients, according to the evidence or not of LV diastolic dysfunction, and then divided in three groups. The LV diastolic dysfunction was characterized as indicated by international recommendations, by the values of E/E' ratio (18). Thus, the patients without LV diastolic dysfunction (E/E'<9) were characterized as group 1. Those with LV diastolic dysfunction (E/E'>9), were divided in two groups, in accordance with the E/E' values: group 2 (the patients with 9<E/E'<13), and group 3 (the patients with E/E'>13).

Obesity will be diagnosed as body mass index (BMI) > 30 (15). All enrolled patients will have T2DM according to international guidelines diagnostic criteria: evidence of fasting plasma glucose of ≥7.0 mmol/L (126 mg/dL; impaired fasting glucose [IFG]), a 2-hour glucose of ≥11.1 mmol/L during a 75 g oral glucose tolerance test (GTT) (>200 mg/dL; impaired glucose tolerance [IGT]), or a plasma hemoglobin (Hb) A1c of ≥48 mmol/mol (≥6.5%), (16).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Diabetes Mellitus, Type 2; Obesity, Abdominal
• Other Study ID Numbers: 0408052023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No