Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT04082351
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2019-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Nanotechnology Structured Water to Control Blood Glucose in Type 2 Diabetic Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D060766', 'term': 'Drinking Water'}], 'ancestors': [{'id': 'D014867', 'term': 'Water'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 387}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-06', 'studyFirstSubmitDate': '2019-09-05', 'studyFirstSubmitQcDate': '2019-09-05', 'lastUpdatePostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'three months', 'description': 'measurement of HbA1c'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nanotechnology water', 'HbA1c', 'Type 2 Diabetes mellitus'], 'conditions': ['Type2 Diabetes']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Sami AKM, Amin KH, Kurmanji MT. The Novel Use of Nanotechnology Structured Water Magnalife to Control Blood Glucose Level in Type 2 Diabetic Patients. Diabetes. 2018;67(Supplement 1):1155.'}]}, 'descriptionModule': {'briefSummary': 'Type 2 DM is due to insulin resistance or low insulin secretion or sometimes a combination of both. Nanotechnology structured water is a type of water that is produced using energy field modulators to change the biological, chemical, and physical properties of water molecules and improve the bioavailability of this nano-water. Objective: To find out the effect of drinking nanotechnology structured water (Magnalife®) on the blood glucose levels in patients with type 2 diabetes mellitus.', 'detailedDescription': 'This is a blind randomized control trial, according to CONSORT guidelines for randomization, "Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 treatment groups.", that included 387 patients with Type 2 diabetes mellitus in Diabetes Care Center, Sulaymaniyah, Kurdistan region from July 2016 till February 2018. A total of 387 patients with type 2 diabetes who were patients in this center and agreed to participate in this clinical trial were included in this study.\n\nIn group A, patients were given nanotechnology structured water Magnalife® and in group B they were given ordinary bottled drinking water as a control . The bottles were unlabeled so that the patients did not know which water they were drinking. Then they were asked to eat their usual food and to drink their usual drinks, also they could drink water ad libitum after drinking the daily doses, and to have the same physical activities that they used to do in their usual daily life. They were instructed to take their medications as usual, and were told to come to test their blood sugar level at the end of the third month to get the HbA1c tested at the end of the three months of drinking the water.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetic patients\n\nExclusion Criteria:\n\n* Malignancy\n* Steroids\n* Immunotherapy\n* Chemotherapy\n* Radiotherapy\n* Chronic infections\n* Drugs that antagonize or synergies insulin effects'}, 'identificationModule': {'nctId': 'NCT04082351', 'briefTitle': 'Using Nanotechnology Structured Water to Control Blood Glucose in Type 2 Diabetic Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University of Sulaimani'}, 'officialTitle': 'Evaluation of Using a Nanotechnology Structured Water Magnalife® to Achieve Controlled Blood Glucose Level in Type 2 Diabetic Patients.', 'orgStudyIdInfo': {'id': 'USulaimani'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Magnalife', 'description': 'the group of patients receiving the nanotechnology structured water', 'interventionNames': ['Dietary Supplement: Nanotechnology structured water ( Magnalife)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Ordinary water', 'description': 'the group of patients receiving ordinary water', 'interventionNames': ['Dietary Supplement: ordinary water']}], 'interventions': [{'name': 'Nanotechnology structured water ( Magnalife)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Magnalife'], 'description': 'Nanotechnology structured water ( Magnalife), is given as dietary supplement to the patients to drink it according to their weight .', 'armGroupLabels': ['Magnalife']}, {'name': 'ordinary water', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Bottled drinking water'], 'description': 'Ordinary bottled water', 'armGroupLabels': ['Ordinary water']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ali K M.Sami, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'College of Medicine, University of Sulaimani'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Six months from the time it is public until one year after the date of being public.', 'ipdSharing': 'YES', 'description': 'The plan may include the levels of HbA1c, the medications used by the patients, the duration of their DM. But no personal data of the patients can be shared according to the agreement with patients under study.', 'accessCriteria': 'To obtain the IPD, an email should be sent to the investigator to ask for IPD and then get access to the plan.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALI KAMAL M. SAMI', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'doctor, lecturer', 'investigatorFullName': 'ALI KAMAL M. SAMI', 'investigatorAffiliation': 'University of Sulaimani'}}}}