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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sarcopenia, Obesity, Diabetes Mellitus, Type 2

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sarcopenic obesity<br>BMI>30, bioelectric impedance positive for sarcopenic obesity (FM% [fat mass percentage] female >43%, male >31% AND SMM/W [skeletal muscle mass/weight] female <28%, male <37%), any one of the physical performance test positive (5-times chair stand test >17 s OR handgrip strength test <35,5 kg for males, <20 kg for females). | |
| Non-sarcopenic obesity<br>BMI>30, bioelectric impedance negative for sarcopenic obesity. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in glycated hemoglobin and/or insulin resistance in diabetic patients with non-sarcopenic obesity vs patients with sarcopenic obesity | Differences in glycated hemoglobin or in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) in patients with sarcopenic obesity vs non-sarcopenic obesity | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irisin protein, Hand Strength [E01.370.600.425.500], Glycated Hemoglobin [D23.946.381.625.500.250]