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

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari (Other)

Overall Status

Recruiting

CT.gov ID

NCT05908812

Collaborator

(none)

Enrollment

Location

8.9

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia Obesity Diabetes Mellitus, Type 2

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

67 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jul 15, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Sarcopenic obesity 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 BMI>30, bioelectric impedance negative for sarcopenic obesity.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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