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Search / Trial NCT05908812

Relationship Between Glycemic Control and Irisin in Type 2 Diabetic Patients With Sarcopenic or Non-sarcopenic Obesity

Launched by AZIENDA OSPEDALIERO-UNIVERSITARIA CONSORZIALE POLICLINICO DI BARI · Jun 8, 2023

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Irisin Protein Hand Strength [E01.370.600.425.500] Glycated Hemoglobin [D23.946.381.625.500.250]

ClinConnect Summary

This clinical trial is exploring how well blood sugar levels are controlled in people with Type 2 diabetes, particularly looking at those who have sarcopenic obesity (a condition where there is an increase in body fat along with a loss of muscle mass) compared to those with non-sarcopenic obesity (where there is excess fat but normal muscle mass). The researchers want to find out if blood sugar control is worse in those with sarcopenic obesity and if levels of a protein called irisin are higher in those with non-sarcopenic obesity.

To participate in this study, individuals need to be over 60 years old, have been diagnosed with Type 2 diabetes less than 10 years ago, and have a body mass index (BMI) over 30, indicating obesity. Participants will complete some lifestyle questionnaires and perform two physical tests. The study will involve taking measurements of body composition, routine blood tests, and measuring irisin levels from a blood sample. This trial is currently recruiting participants and aims to help us understand more about the relationship between obesity, muscle mass, and diabetes management.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Diabetes mellitus type 2 diagnosed less than 10 years before
  • age \>60 years
  • BMI (Body Mass Index) \>30 kg/m2
  • eGFR (estimated Glomerular Filtration Rate) \>30 ml/min
  • On stable antidiabetic therapy for at least 3 months
  • Exclusion Criteria:
  • Insulin or insulin secretagogues use
  • Diabetes mellitus type 1, previous diabetic ketoacidosis
  • Neuromuscular diseases
  • Endocrinopathies that may cause myopathies (hypercortisolism, GH \[growth hormone\] deficiency, acromegaly, adrenal insufficiency, partial hypopituitarism or panhypopituitarism, male hypogonadism, hyperparathyroidism, hypoparathyroidism)
  • Severe vit. D deficiency (\<12 ng/ml)
  • Hemoglobinopathies
  • Prolonged immobilization
  • Pathologies with fluid retention (heart failure with NYHA \[New York Heart Association\] class III/IV, severe renal insufficiency, hepatic insufficiency)
  • Active tumors in the past 5 years
  • Severe arthritis of the knee or hip
  • Pacemaker wearer

About Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari

The Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari is a prominent healthcare institution in Italy, dedicated to advancing medical research and clinical excellence. As a leading clinical trial sponsor, it integrates hospital and university resources to foster innovative research initiatives aimed at improving patient care and treatment outcomes. The institution is committed to upholding the highest ethical standards in clinical trials, ensuring rigorous scientific methodologies and patient safety. With a multidisciplinary approach, the Policlinico di Bari collaborates with various academic and research organizations, positioning itself at the forefront of medical discovery and healthcare advancement.

Locations

Bari, , Italy

Patients applied

0 patients applied

Trial Officials

Francesco Giorgino, MD, PhD

Principal Investigator

Director of U.O.C. Endocrinology and Metabolism, Policlinico di Bari

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported