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

Relationship Between Parameters of Glycemic Control and Irisin Levels in Patients With Diabetes Mellitus Type 2 and Sarcopenic Obesity or Non-sarcopenic Obesity

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05908812
Enrollment
120
Registered
2023-06-18
Start date
2023-02-01
Completion date
2025-01-31
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Obesity, Sarcopenia

Keywords

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

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

Detailed description

Patients will be enrolled from our Diabetology Center. Eligible patients will be contacted by phone to be informed of the procedures and to schedule the visit. The patients will come to the visit bringing the blood analyses they usually bring for the routine diabetologic visit; they will also be fasting for at least 3 hours, and abstaining from smoking and physical activity since the day before. All visits will be performed in the afternoon, at about 4-6 p.m. Participants will be asked to: * Fill in three questionaries (SARC-F \[Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire\], IPAQ-EIT \[International Physical Activity Questionnaire validated in the Elderly Italian population\], MEDI-LITE \[Adherence to the Mediterranean diet questionnaire\]) * Perform two physical performance tests (5-times chair stand test and handgrip test). Anthropometric measurements will be assessed; body composition will be evaluated by bioelectrical impedance analysis. A venous blood draw will be executed for evaluation of irisin levels after signing a written consent form.

Interventions

None listed

Sponsors

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Differences in glycated hemoglobin and/or insulin resistance in diabetic patients with non-sarcopenic obesity vs patients with sarcopenic obesityBaselineDifferences in glycated hemoglobin or in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) in patients with sarcopenic obesity vs non-sarcopenic obesity

Countries

Italy

Contacts

Primary ContactFrancesco Giorgino, MD, PhD
francesco.giorgino@uniba.it+390805593522

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026