Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT06958302
Status:
RECRUITING
Last Update Posted:
2025-05-06
First Post:
2025-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Relation Between Diabetic Neuropathy and Muscle Mass in Type 2 Diabetes Mellitus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-26', 'studyFirstSubmitDate': '2025-04-06', 'studyFirstSubmitQcDate': '2025-04-26', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relation between diabetic neuropathy and muscle mass', 'timeFrame': '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', 'description': "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)"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetic neuropathy', 'muscle mass', 'sarcopenia', 'nerve conduction studies'], 'conditions': ['Diabetic Neuropathy', 'Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '34121127', 'type': 'BACKGROUND', 'citation': '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': '34674473', 'type': 'BACKGROUND', 'citation': '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': '26728934', 'type': 'BACKGROUND', 'citation': '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': '28555708', 'type': 'BACKGROUND', 'citation': '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': '32941253', 'type': 'BACKGROUND', 'citation': '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': '32259181', 'type': 'BACKGROUND', 'citation': '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': '25201711', 'type': 'BACKGROUND', 'citation': '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': '30953961', 'type': 'BACKGROUND', 'citation': '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': '33083494', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the relation between diabetic neuropathy in type 2 diabetes mellitus patients and muscle mass', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'genderBased': False, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study group consisted of patients diagnosed with Type 2 diabetes mellitus aged ≥45 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study group consisted of patients diagnosed with Type 2 diabetes mellitus aged ≥45 years old\n\nExclusion Criteria:\n\n* Type 1 DM, gestational diabetes mellitus\n* 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\n* Other neuropathy-associated factors such as: alcohol, nutrition, poisoning and drug addiction\n* Patients with renal diseases, malignancy and autoimmune diseases\n* Patients on long term use of Steroids'}, 'identificationModule': {'nctId': 'NCT06958302', 'briefTitle': 'The Relation Between Diabetic Neuropathy and Muscle Mass in Type 2 Diabetes Mellitus Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Relation Between Diabetic Neuropathy and Muscle Mass in Type 2 Diabetes Mellitus Patients', 'orgStudyIdInfo': {'id': 'FMASU MD16/2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'type 2 diabetic patients', 'description': 'type 2 diabetes mellitus patients aged above 45 years old and tested for diabetic neuropathy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00202', 'city': 'Cairo', 'state': 'Abbassia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Wafaa M Mohamed Abd ElAzim, Masters', 'role': 'CONTACT', 'email': 'wafaa.mahmoud.@med.asu.edu.eg', 'phone': '+201012932752'}], 'facility': 'Ain Shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '00202', 'city': 'Cairo', 'state': 'Abbassia', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Ain Shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Wafaa M Mohamed Abd ElAzim, Masters degree', 'role': 'CONTACT', 'email': 'wafaa.mahmoud@med.asu.edu.eg', 'phone': '+201012932752'}], 'overallOfficials': [{'name': 'Rana A Al Hilaly, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}