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Using Nanotechnology Structured Water to Control Blood Glucose in Type 2 Diabetic Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082351
Recruitment Status : Completed
First Posted : September 9, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
ALI KAMAL M. SAMI, University of Sulaimani

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Dietary Supplement: Nanotechnology structured water ( Magnalife) Dietary Supplement: ordinary water Not Applicable

Detailed Description:

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.

In 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 387 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Using a Nanotechnology Structured Water Magnalife® to Achieve Controlled Blood Glucose Level in Type 2 Diabetic Patients.
Actual Study Start Date : July 3, 2016
Actual Primary Completion Date : February 16, 2018
Actual Study Completion Date : February 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Magnalife
the group of patients receiving the nanotechnology structured water
Dietary Supplement: Nanotechnology structured water ( Magnalife)
Nanotechnology structured water ( Magnalife), is given as dietary supplement to the patients to drink it according to their weight .
Other Name: Magnalife

Placebo Comparator: Ordinary water
the group of patients receiving ordinary water
Dietary Supplement: ordinary water
Ordinary bottled water
Other Name: Bottled drinking water




Primary Outcome Measures :
  1. HbA1c [ Time Frame: three months ]
    measurement of HbA1c



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetic patients

Exclusion Criteria:

  • Malignancy
  • Steroids
  • Immunotherapy
  • Chemotherapy
  • Radiotherapy
  • Chronic infections
  • Drugs that antagonize or synergies insulin effects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082351


Sponsors and Collaborators
ALI KAMAL M. SAMI
Investigators
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Principal Investigator: Ali K M.Sami, Ph.D. College of Medicine, University of Sulaimani
Publications of Results:
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.

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Responsible Party: ALI KAMAL M. SAMI, doctor, lecturer, University of Sulaimani
ClinicalTrials.gov Identifier: NCT04082351    
Other Study ID Numbers: USulaimani
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Six months from the time it is public until one year after the date of being public.
Access Criteria: To obtain the IPD, an email should be sent to the investigator to ask for IPD and then get access to the plan.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ALI KAMAL M. SAMI, University of Sulaimani:
Nanotechnology water
HbA1c
Type 2 Diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases