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

September 6, 2019 updated by: ALI KAMAL M. SAMI

Evaluation of Using a Nanotechnology Structured Water Magnalife® to Achieve Controlled Blood Glucose Level in Type 2 Diabetic Patients.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

387

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetic patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Magnalife
Placebo Comparator: Ordinary water
the group of patients receiving ordinary water
Dietary supplement: ordinary water
Ordinary bottled water
Other Names:
  • Bottled drinking water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: three months
measurement of HbA1c
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALI KAMAL M. SAMI

Investigators

  • Principal Investigator: Ali K M.Sami, Ph.D., College of Medicine, University of Sulaimani

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2016

Primary Completion (Actual)

February 16, 2018

Study Completion (Actual)

February 16, 2018

Study Registration Dates

First Submitted

September 5, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (Actual)

September 9, 2019

Study Record Updates

Last Update Posted (Actual)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 6, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USulaimani

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Time Frame

Six months from the time it is public until one year after the date of being public.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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