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

NCT ID: NCT06958302

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-30

Study Completion Date

2026-06-15

Brief Summary

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

Detailed Description

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The goal of this observational study is to evaluate the relation between diabetic neuropathy in type 2 diabetes mellitus patients, aged above 45 years old, and muscle mass; where it uses ultrasound to measure anterior thigh muscle thickness and adjusts it to body mass index to calculate muscle mass and the participants perform clinical tests i.e hand grip strength test and chair stand test in order to assess muscle power. Depending on both muscle mass and muscle power/function, Sarcopenia could be assessed in this group of patients, and its relation to diabetic neuropathy, tested by nerve conduction studies, would be researched.

Conditions

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Diabetic Neuropathy Sarcopenia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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type 2 diabetic patients

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rana A Al Hilaly, MD

Role: STUDY_DIRECTOR

Ain Shams University

Locations

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Ain Shams university

Cairo, Abbassia, Egypt

Site Status RECRUITING

Ain Shams university

Cairo, Abbassia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Wafaa M Mohamed Abd ElAzim, Masters degree

Role: CONTACT

+201012932752

Facility Contacts

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Wafaa M Mohamed Abd ElAzim, Masters

Role: primary

+201012932752

References

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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.

Reference Type BACKGROUND
PMID: 34121127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34674473 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26728934 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28555708 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32941253 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32259181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25201711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30953961 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33083494 (View on PubMed)

Other Identifiers

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FMASU MD16/2025

Identifier Type: -

Identifier Source: org_study_id

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