Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT06120569
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2023-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Role of Soleus Muscle Exercise in Glycaemic Control in Diabetic Kidney Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-04', 'studyFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2023-11-04', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1C less than 7%', 'timeFrame': 'One year', 'description': 'Improve HbA1c by soleus muscle exercise'}], 'secondaryOutcomes': [{'measure': 'ratio of albumin (mcg/L) to creatinine (mg/L)ratio', 'timeFrame': 'One year', 'description': 'Improve alb /creatinine ratio'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Kidney Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://pubmed.ncbi.nlm.nih.gov/30559231/', 'label': 'Pudmed'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the role of Soleus muscle exercise in management diabetic kidney disease', 'detailedDescription': "management of diabetic kidney disease. To enhance their glycemic control, diabetic patients are advised to perform 150 minutes per week of moderate-to-vigorous aerobic activity Diabetic patients with regular physical activity have reduced daily insulin dose with more glycemic control. In addition to glycemic control, it has also been postulated that the addition of brief intervals of high intensity, sprint -type exercise to aerobic exercise can decrease the risk of late nocturnal hypoglycemic episodes Marc T. Hamilton et al., 2022, reported that the human soleus muscle could raise local oxidative metabolism to high levels for hours without fatigue, during a type of soleus-dominant activity while sitting (soleus push up exercise), even in unfit volunteers. They reported that soleus push up exercise can improve systemic VLDL-triglyceride and glucose homeostasis by a large magnitude, e.g., 52% less postprandial glucose excursion (∼50 mg/dL less between ∼1 and 2 h) with 60% less hyperinsulinemia. Muscle biopsies revealed there was minimal glycogen use. This can be explained that the soleus doesn't rely completely on intramuscular glycogen, Instead, it uses a mixture of fuels from glucose and lipoproteins."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age 18-60 yrs.,\n* patients with Diabetic kidney disease, not on dialysis\n* with stabilized diabetic treatment regimen for 3 months before participating in the study\n\nExclusion Criteria:\n\n* advanced osteoarthritis of lower limb joints\n* advanced poly neuropathic patients\n* CKD type V on dialysis\n* Diabetic Foot\n* hemophilia\n* bleeding tendency\n* AKI\n* other causes of chronic kidney disease\n* patients refuse to participate in the study'}, 'identificationModule': {'nctId': 'NCT06120569', 'briefTitle': 'Evaluate the Role of Soleus Muscle Exercise in Glycaemic Control in Diabetic Kidney Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Evaluate the Role of Soleus Muscle Exercise in Glycaemic Control in Diabetic Kidney Disease Patients', 'orgStudyIdInfo': {'id': 'Soleus ms exercise in diabetis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Soleus muscle exercise in diabetes', 'description': 'Soleus muscle decrease blood glucose', 'interventionNames': ['Device: Soleus ms exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Decrease glucose level by soleus exercise', 'description': 'Soleus ms exercise in decrease blood glucose', 'interventionNames': ['Device: Soleus ms exercise']}], 'interventions': [{'name': 'Soleus ms exercise', 'type': 'DEVICE', 'description': 'Soleus muscle exercise before and after eating by half an hour', 'armGroupLabels': ['Decrease glucose level by soleus exercise', 'Soleus muscle exercise in diabetes']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nora Kamal, Resident', 'role': 'CONTACT', 'email': 'norahussein097@gmail.com', 'phone': '01002380242'}, {'name': 'Ashraf El - Shazly, Prof', 'role': 'CONTACT', 'email': 'Ashrafshazly58@gmail.com', 'phone': '01062879221'}], 'overallOfficials': [{'name': 'Samir Kamal, Ass prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Superviosor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nora Hussein Kamal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Internal medicine doctor', 'investigatorFullName': 'Nora Hussein Kamal', 'investigatorAffiliation': 'Assiut University'}}}}