Type2 DiabetesNCT04082351
Using Nanotechnology Structured Water to Control Blood Glucose in Type 2 Diabetic Patients.
A study testing Nanotechnology structured water ( Magnalife) and ordinary water in people with Type2 Diabetes, run by ALI KAMAL M. SAMI.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Nanotechnology structured water ( Magnalife) and ordinary water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 387 participants
- Where
- No sites listed yet
- Study dates
- 3 Jul 2016to 16 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 2 diabetic patients
Who cannot join
- Malignancy
- Steroids
- Immunotherapy
- Chemotherapy
- Radiotherapy
- Chronic infections
- Drugs that antagonize or synergies insulin effects
About this study
Official title: 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.
Read the 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.
- Conditions
- Type2 Diabetes
- Being tested
- Nanotechnology structured water ( Magnalife), ordinary water
- Keywords
- Nanotechnology water, HbA1c, Type 2 Diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanotechnology structured water ( Magnalife)Dietary supplement
Also called Magnalife
Nanotechnology structured water ( Magnalife), is given as dietary supplement to the patients to drink it according to their weight .
ordinary waterDietary supplement
Also called Bottled drinking water
Ordinary bottled water
| Study group | Role | What they receive |
|---|---|---|
| Magnalife | Active comparator | the group of patients receiving the nanotechnology structured water Receives: Dietary Supplement: Nanotechnology structured water ( Magnalife) |
| Ordinary water | Placebo comparator | the group of patients receiving ordinary water Receives: Dietary Supplement: ordinary water |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
measurement of HbA1c
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start3 Jul 2016
- Primary completion16 Feb 2018
- Study completion16 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALI KAMAL M. SAMI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ALI KAMAL M. SAMI, University of Sulaimani
- Investigators
- Ali K M.Sami, Ph.D., Principal investigator, College of Medicine, University of Sulaimani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082351
- Sponsor's protocol ID
- USulaimani
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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 at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Using a Nanotechnology Structured Water Magnalife® to Achieve Controlled Blood Glucose Level in Type 2 Diabetic Patients.
- ClinicalTrials.gov ID
- NCT04082351
- Acronym / sponsor ID
- USulaimani
- Conditions
- Type2 Diabetes
- Keywords
- Nanotechnology water, HbA1c, Type 2 Diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- ALI KAMAL M. SAMIUniversity, hospital or other
- Study start
- 3 Jul 2016 (actual)
- Primary completion
- 16 Feb 2018 (actual)
- Study completion
- 16 Feb 2018 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnalife | Active comparator | Dietary Supplement: Nanotechnology structured water ( Magnalife)the group of patients receiving the nanotechnology structured water |
| Ordinary water | Placebo comparator | Dietary Supplement: ordinary waterthe group of patients receiving ordinary water |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetic patients
Key exclusion criteria (7 listed)
- Malignancy
- Steroids
- Immunotherapy
- Chemotherapy
- Radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanotechnology structured water ( Magnalife)Also: MagnalifeNanotechnology structured water ( Magnalife), is given as dietary supplement to the patients to drink it according to their weight . | Dietary supplement | Magnalife |
| ordinary waterAlso: Bottled drinking waterOrdinary bottled water | Dietary supplement | Ordinary water |
Primary outcome
HbA1c
Time frame: three months
measurement of HbA1c
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Results publicationSami 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali K M.Sami, Ph.D. principal investigator
College of Medicine, University of Sulaimani
Questions about this trial
What is this clinical trial studying?
A study testing Nanotechnology structured water ( Magnalife) and ordinary water in people with Type2 Diabetes, run by ALI KAMAL M. SAMI.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.