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

NCT05908812 | Recruiting

• 1 other identifier: 0023237|08/03/2023
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

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]

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead

Study Sites (1)

Policlinico di Bari

Bari, 70124, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 35196654 BACKGROUND

• 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.

  PMID: 27220658 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.

  PMID: 34190188 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood

MeSH Terms

Conditions

Sarcopenia; Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Francesco Giorgino, MD, PhD

  Director of U.O.C. Endocrinology and Metabolism, Policlinico di Bari

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Giorgino, MD, PhD

CONTACT

+390805593522; francesco.giorgino@uniba.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: June 18, 2023
• Study Start: February 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)