NCT04082351

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
387

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

September 5, 2019

Last Update Submit

September 6, 2019

Conditions

Keywords

Nanotechnology waterHbA1cType 2 Diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    measurement of HbA1c

    three months

Study Arms (2)

Magnalife

ACTIVE COMPARATOR

the group of patients receiving the nanotechnology structured water

Dietary Supplement: Nanotechnology structured water ( Magnalife)

Ordinary water

PLACEBO COMPARATOR

the group of patients receiving ordinary water

Dietary Supplement: ordinary water

Interventions

Nanotechnology structured water ( Magnalife), is given as dietary supplement to the patients to drink it according to their weight .

Also known as: Magnalife
Magnalife
ordinary waterDIETARY_SUPPLEMENT

Ordinary bottled water

Also known as: Bottled drinking water
Ordinary water

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetic patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Drinking Water

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

WaterHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ali K M.Sami, Ph.D.

    College of Medicine, University of Sulaimani

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor, lecturer

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 9, 2019

Study Start

July 3, 2016

Primary Completion

February 16, 2018

Study Completion

February 16, 2018

Last Updated

September 10, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.