NCT05908812 Relationship Between Glycemic Control and Irisin in Type 2 Diabetic Patients With Sarcopenic or Non-sarcopenic Obesity
| NCT ID | NCT05908812 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari |
| Condition | Sarcopenia |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2025-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2023-02-01 with a primary completion date of 2025-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to compare glycemic control and irisin levels in subjects with diabetes mellitus type 2 with sarcopenic obesity vs non-sarcopenic obesity. The main questions it aims to answer are: Is glycemic control worse in diabetic patients with sarcopenic obesity? Are irisin levels higher in patients with non-sarcopenic obesity? Participants will be asked to: * Fill in three questionaries on lifestyle * Perform two physical performance tests The investigators will collect the following data: * Anthropometric measurements * Body composition by bioelectrical impedance analysis. * Results of routine blood analyses * Irisin levels by drawing a vial of blood from the antecubital vein
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
Contact & Investigator
Francesco Giorgino, MD, PhD
PRINCIPAL INVESTIGATOR
Director of U.O.C. Endocrinology and Metabolism, Policlinico di Bari
Frequently Asked Questions
Who can join the NCT05908812 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Sarcopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05908812 currently recruiting?
Yes, NCT05908812 is actively recruiting participants. Contact the research team at francesco.giorgino@uniba.it for enrollment information.
Where is the NCT05908812 trial being conducted?
This trial is being conducted at Bari, Italy.
Who is sponsoring the NCT05908812 clinical trial?
NCT05908812 is sponsored by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari. The principal investigator is Francesco Giorgino, MD, PhD at Director of U.O.C. Endocrinology and Metabolism, Policlinico di Bari. The trial plans to enroll 120 participants.