Obesity Clinical Trial - Relationship Between Glycemic Control & Irisin in

Status Recruiting

Clinical Trial 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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05908812
Study type	Observational
Source	Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Contact	Francesco Giorgino, MD, PhD
Phone	+390805593522
Email	francesco.giorgino@uniba.it
Status	Recruiting
Phase
Start date	February 1, 2023
Completion date	January 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms