Diabetic NeuropathyNCT06958302
The Relation Between Diabetic Neuropathy and Muscle Mass in Type 2 Diabetes Mellitus Patients
An observational study of Diabetic Neuropathy and Sarcopenia, run by Ain Shams University at 2 sites in Egypt.
Trial summary
The goal of this observational study is to evaluate the relation between diabetic neuropathy in type 2 diabetes mellitus patients and muscle mass Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Diabetic Neuropathy, Sarcopenia
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 30 May 2025to 15 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study group consisted of patients diagnosed with Type 2 diabetes mellitus aged ≥45 years old
Who may be able to join
- The study group consisted of patients diagnosed with Type 2 diabetes mellitus aged ≥45 years old
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Ain Shams university
Cairo, Abbassia, 00202
Wafaa M Mohamed Abd ElAzim, Masters, +201012932752, wafaa.mahmoud.@med.asu.edu.eg
- Recruiting
Ain Shams university
Cairo, Abbassia, 00202
About this study
The goal of this observational study is to evaluate the relation between diabetic neuropathy in type 2 diabetes mellitus patients and muscle mass
Read the 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.
- Conditions
- Diabetic Neuropathy, Sarcopenia
- Keywords
- diabetic neuropathy, muscle mass, sarcopenia, nerve conduction studies
- Medical subject headings
- Diabetic Neuropathies, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| type 2 diabetic patients | type 2 diabetes mellitus patients aged above 45 years old and tested for diabetic neuropathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start30 May 2025 (estimated)
- Primary completion10 Nov 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rana A Al Hilaly, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958302
- Sponsor's protocol ID
- FMASU MD16/2025
- Status last verified
- Mar 2025
- First submitted
- 6 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34121127Perkisas 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.
PubMed 34674473Pinheiro 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.
PubMed 26728934Bohannon 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.
PubMed 28555708Kara 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.
PubMed 32941253Tsukasaki 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.
PubMed 32259181Abe 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.
PubMed 25201711Ata 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.
PubMed 30953961Chen 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.
PubMed 33083494
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Diabetic Neuropathy and Muscle Mass in Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT06958302
- Acronym / sponsor ID
- FMASU MD16/2025
- Conditions
- Diabetic Neuropathy, Sarcopenia
- Keywords
- diabetic neuropathy, muscle mass, sarcopenia, nerve conduction studies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 10 Nov 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetic patients | – | –type 2 diabetes mellitus patients aged above 45 years old and tested for diabetic neuropathy |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study group consisted of patients diagnosed with Type 2 diabetes mellitus aged ≥45 years old
Key inclusion criteria (1 listed)
- The study group consisted of patients diagnosed with Type 2 diabetes mellitus aged ≥45 years old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Background: PubMed 34121127Kara 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.
- Background: PubMed 34674473Perkisas 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.
- Background: PubMed 26728934Pinheiro 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.
- Background: PubMed 28555708Bohannon 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.
- Background: PubMed 32941253Kara 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.
- Background: PubMed 32259181Tsukasaki 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.
- Background: PubMed 25201711Abe 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.
- Background: PubMed 30953961Ata 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.
- Background: PubMed 33083494Chen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rana A Al Hilaly, MD study director
Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Neuropathy and Sarcopenia, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wafaa M Mohamed Abd ElAzim, Masters degree (+201012932752, wafaa.mahmoud@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06958302, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.