RecruitingNot Applicable

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

Italy120 participantsStarted 2023-02-01

Plain-language 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

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Differences in glycated hemoglobin and/or insulin resistance in diabetic patients with non-sarcopenic obesity vs patients with sarcopenic obesity

Timeframe: Baseline

Trial details

NCT IDNCT05908812

SponsorAzienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-31

Contact for this trial

Francesco Giorgino, MD, PhD

+390805593522 francesco.giorgino@uniba.it

View on ClinicalTrials.gov More Sarcopenia trials