Clinical trial NCT05908812: Relationship Between Glycemic Control and Irisin in Type 2 Diabetic Patients With Sarcopenic or Non-sarcopenic Obesity
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcopenia
Obesity
Diabetes Mellitus, Type 2
Keywords: Irisin protein
Hand Strength [E01.370.600.425.500]
Glycated Hemoglobin [D23.946.381.625.500.250]
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from our Center's patients. A physician will screen the eligible patients from the automatic search on the database from the program Smart Digital Clinic.

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.

Eligibility 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

Primary outcomes:
measure: Differences in glycated hemoglobin and/or insulin resistance in diabetic patients with non-sarcopenic obesity vs patients with sarcopenic obesity
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Policlinico di Bari
Study officials:
affiliation: Director of U.O.C. Endocrinology and Metabolism, Policlinico di Bari
name: Francesco Giorgino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Donini LM, Busetto L, Bischoff SC, Cederholm T, Ballesteros-Pomar MD, Batsis JA, Bauer JM, Boirie Y, Cruz-Jentoft AJ, Dicker D, Frara S, Fruhbeck G, Genton L, Gepner Y, Giustina A, Gonzalez MC, Han HS, Heymsfield SB, Higashiguchi T, Laviano A, Lenzi A, Nyulasi I, Parrinello E, Poggiogalle E, Prado CM, Salvador J, Rolland Y, Santini F, Serlie MJ, Shi H, Sieber CC, Siervo M, Vettor R, Villareal DT, Volkert D, Yu J, Zamboni M, Barazzoni R. Definition and Diagnostic Criteria for Sarcopenic Obesity: ESPEN and EASO Consensus Statement. Obes Facts. 2022;15(3):321-335. doi: 10.1159/000521241. Epub 2022 Feb 23.
citation: Shoukry A, Shalaby SM, El-Arabi Bdeer S, Mahmoud AA, Mousa MM, Khalifa A. Circulating serum irisin levels in obesity and type 2 diabetes mellitus. IUBMB Life. 2016 Jul;68(7):544-56. doi: 10.1002/iub.1511. Epub 2016 May 24.
citation: Oguz A, Sahin M, Tuzun D, Kurutas EB, Ulgen C, Bozkus O, Gul K. Irisin is a predictor of sarcopenic obesity in type 2 diabetes mellitus: A cross-sectional study. Medicine (Baltimore). 2021 Jul 2;100(26):e26529. doi: 10.1097/MD.0000000000026529.