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OpenTrials
Completed

NCT Number: NCT05988346

Ghrelin and Diastolic Heart Function

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Diastolic Dysfunction Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Celestino Sardu

Naples, 80138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

abdominal plastic intervention

Procedure

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

Primary outcomes

  1. normalization of LV diastolic dysfunction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Aug 14, 2023
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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