Examining the link between glycemic control and irisin levels in obese diabetic patients
Relationship Between Parameters of Glycemic Control and Irisin Levels in Patients With Diabetes Mellitus Type 2 and Sarcopenic Obesity or Non-sarcopenic Obesity
This study is trying to see how well blood sugar is controlled and how irisin levels vary in people with type 2 diabetes who have different types of obesity.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari Academic / other |
| Locations | 1 site (Bari) |
| Trial ID | NCT05908812 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare glycemic control and irisin levels in patients with type 2 diabetes who have either sarcopenic obesity or non-sarcopenic obesity. Participants will complete questionnaires related to lifestyle and undergo physical performance tests. Data collected will include anthropometric measurements, body composition analysis, routine blood tests, and irisin levels through blood draws. The study will enroll patients from a Diabetology Center and will focus on those diagnosed with diabetes within the last 10 years.
Who should consider this trial
Good fit: Ideal candidates are individuals over 60 years old with type 2 diabetes diagnosed less than 10 years ago and a BMI over 30 kg/m2.
Not a fit: Patients with type 1 diabetes, those using insulin or insulin secretagogues, or individuals with certain neuromuscular diseases or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the relationship between obesity types and glycemic control, potentially guiding better management strategies for diabetic patients.
How similar studies have performed: While this study explores a specific relationship, similar studies have shown varying results regarding the impact of obesity on glycemic control, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bari
- Policlinico di Bari — Bari, Italy (Recruiting)
Study contacts
- Principal investigator: Francesco Giorgino, MD, PhD — Director of U.O.C. Endocrinology and Metabolism, Policlinico di Bari
- Study coordinator: Francesco Giorgino, MD, PhD
- Email: francesco.giorgino@uniba.it
- Phone: +390805593522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.