The Relation Between Diabetic Neuropathy and Muscle Mass in Type 2 Diabetes Mellitus Patients

NCT06958302 | Recruiting

• 1 other identifier: FMASU MD16/2025
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to evaluate the relation between diabetic neuropathy in type 2 diabetes mellitus patients and muscle mass

Conditions

Diabetic Neuropathy; Sarcopenia

Keywords

diabetic neuropathy; muscle mass; sarcopenia; nerve conduction studies

Outcome Measures

Primary Outcomes (1)

• Relation between diabetic neuropathy and muscle mass

  Relation between Diabetic neuropathy severity (mild/moderate/severe) using nerve conduction studies classification criteria (Baba's classification) and skeletal muscle mass as indicated by a ratio (anterior thigh muscle thickness measured by ultrasound/ BMI) (millimeteres for muscle thickness ) and (kg/m\^2 for the BMI)

  Day 1 Neurological examination and clinical physical performance tests for sarcopenia, 2 weeks later: nerve conduction studies for both lower limbs, the 3rd week: ultrasound assessment for thigh muscle thickness

Study Arms (1)

type 2 diabetic patients

type 2 diabetes mellitus patients aged above 45 years old and tested for diabetic neuropathy

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study group consisted of patients diagnosed with Type 2 diabetes mellitus aged ≥45 years old

You may qualify if:

• The study group consisted of patients diagnosed with Type 2 diabetes mellitus aged ≥45 years old

You may not qualify if:

• Type 1 DM, gestational diabetes mellitus
• Severe cardiopulmonary disease, significant/previous neurological disorder (e.g., ischemic stroke, Parkinson disease) causing difficulty during daily activities (e.g., walking), visual deficit, and psychiatric problem
• Other neuropathy-associated factors such as: alcohol, nutrition, poisoning and drug addiction
• Patients with renal diseases, malignancy and autoimmune diseases
• Patients on long term use of Steroids

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Ain Shams university

Cairo, Abbassia, 00202, Egypt

RECRUITING

Ain Shams university

Cairo, Abbassia, 00202, Egypt

RECRUITING

Related Publications (9)

• Kara M, Kaymak B, Frontera W, Ata AM, Ricci V, Ekiz T, Chang KV, Han DS, Michail X, Quittan M, Lim JY, Bean JF, Franchignoni F, Ozcakar L. Diagnosing sarcopenia: Functional perspectives and a new algorithm from the ISarcoPRM. J Rehabil Med. 2021 Jun 21;53(6):jrm00209. doi: 10.2340/16501977-2851.

  PMID: 34121127 BACKGROUND

• Perkisas S, Baudry S, Bauer J, Beckwee D, De Cock AM, Hobbelen H, Jager-Wittenaar H, Kasiukiewicz A, Landi F, Marco E, Merello A, Piotrowicz K, Sanchez E, Sanchez-Rodriguez D, Scafoglieri A, Cruz-Jentoft A, Vandewoude M. Application of ultrasound for muscle assessment in sarcopenia: towards standardized measurements. Eur Geriatr Med. 2018 Dec;9(6):739-757. doi: 10.1007/s41999-018-0104-9. Epub 2018 Sep 17.

  PMID: 34674473 BACKGROUND

• Pinheiro PA, Carneiro JA, Coqueiro RS, Pereira R, Fernandes MH. "Chair Stand Test" as Simple Tool for Sarcopenia Screening in Elderly Women. J Nutr Health Aging. 2016 Jan;20(1):56-9. doi: 10.1007/s12603-016-0676-3.

  PMID: 26728934 BACKGROUND

• Bohannon RW. Test-Retest Reliability of Measurements of Hand-Grip Strength Obtained by Dynamometry from Older Adults: A Systematic Review of Research in the PubMed Database. J Frailty Aging. 2017;6(2):83-87. doi: 10.14283/jfa.2017.8.

  PMID: 28555708 BACKGROUND

• Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.

  PMID: 32941253 BACKGROUND

• Tsukasaki K, Matsui Y, Arai H, Harada A, Tomida M, Takemura M, Otsuka R, Ando F, Shimokata H. Association of Muscle Strength and Gait Speed with Cross-Sectional Muscle Area Determined by Mid-Thigh Computed Tomography - A Comparison with Skeletal Muscle Mass Measured by Dual-Energy X-Ray Absorptiometry. J Frailty Aging. 2020;9(2):82-89. doi: 10.14283/jfa.2020.16.

  PMID: 32259181 BACKGROUND

• Abe T, Loenneke JP, Thiebaud RS, Ogawa M, Mitsukawa N. Age-related site-specific muscle loss in the thigh and zigzag walking performance in older men and women. Acta Physiol Hung. 2014 Dec;101(4):488-95. doi: 10.1556/APhysiol.101.2014.006.

  PMID: 25201711 BACKGROUND

• Ata AM, Kara M, Kaymak B, Gurcay E, Cakir B, Unlu H, Akinci A, Ozcakar L. Regional and total muscle mass, muscle strength and physical performance: The potential use of ultrasound imaging for sarcopenia. Arch Gerontol Geriatr. 2019 Jul-Aug;83:55-60. doi: 10.1016/j.archger.2019.03.014. Epub 2019 Mar 19.

  PMID: 30953961 BACKGROUND

• Chen F, Xu S, Wang Y, Chen F, Cao L, Liu T, Huang T, Wei Q, Ma G, Zhao Y, Wang D. Risk Factors for Sarcopenia in the Elderly with Type 2 Diabetes Mellitus and the Effect of Metformin. J Diabetes Res. 2020 Oct 7;2020:3950404. doi: 10.1155/2020/3950404. eCollection 2020.

  PMID: 33083494 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies; Sarcopenia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Rana A Al Hilaly, MD

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Wafaa M Mohamed Abd ElAzim, Masters degree

CONTACT

+201012932752; wafaa.mahmoud@med.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: May 6, 2025
• Study Start: May 30, 2025
• Primary Completion: November 10, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-03

Locations

EG (2)