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

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status: Enrolling

Conditions: Obesity; Diabetes Mellitus, Type 2; Sarcopenia

Study type: Observational

Funder types: Other

Identifiers

NCT05908812

0023237|08/03/2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Sarcopenic obesity

Description:

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

Description:

BMI\>30, bioelectric impedance negative for sarcopenic obesity.