The Relation Between Diabetic Neuropathy and Muscle Mass in Type 2 Diabetes Mellitus Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetic Neuropathy, Sarcopenia. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Primary outcome measures
- Relation between diabetic neuropathy and muscle mass [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Egypt · 2 centers
- Ain Shams university — Cairo
- Ain Shams university — Cairo
Publications
- 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
- 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 PMID 34674473
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT06958302 · FMASU MD16/2025