Ghrelin and Diastolic Heart Function

NCT05988346 | Completed

• 1 other identifier: 0408052023
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Procedure: abdominal plastic intervention

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

Procedure: abdominal plastic intervention

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

Procedure: abdominal plastic intervention

Interventions

abdominal plastic intervention 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.; T2DM obese patients with second degree of left ventricle (LV) diastolic dysfunction.; type 2 diabetes mellitus (T2DM) obese patients without left ventricle (LV) diastolic dysfunction.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Clinical diagnosis of T2DM obese patients;
• T2DM obese patients under anti-diabetic full medical therapy and glycemic control.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Celestino Sardu

Naples, 80138, Italy

Location

Related Publications (1)

• 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.

  PMID: 40323144 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Authors will analyze biospecimen from the removed abdominal adipose tissue.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity, Abdominal

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: January 1, 2016
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

IT (1)