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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:
The investigators will collect the following data:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Giorgino, MD, PhD | Contact | +390805593522 | francesco.giorgino@uniba.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Giorgino, MD, PhD | Director of U.O.C. Endocrinology and Metabolism, Policlinico di Bari | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico di Bari | Recruiting | Bari | 70124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35196654 | Background | 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. | |
| 27220658 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Dec 27, 2022 | Jun 7, 2023 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Venous blood
| Result |
| 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. |
| 34190188 | Result | 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. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |