Evaluation of the effect of deuterium-depleted water on lipid profile,liver enzymes and level of inflammatory markers including CPR and ESR in type 2 diabetic patients

Investigating the effect of deuterium-depleted water on lipid profile, liver enzyme levels, and inflammatory markers in type 2 diabetic patients.

A parallel-group, double-blind, block-randomized, phase 3 clinical trial on 96 patients.

In this double-blind clinical trial, patients with type 2 diabetes referred to Luqman Hospital will be admitted. Background information including demographic characteristics, weight and height, clinical manifestations, laboratory parameters on the day of admission, the amount of calories consumed, the amount of daily sports activity and the type of drug treatment received are collected. Patients are randomly divided into two groups. The first group is treated with 1.5 liters (equivalent to the usual volume of drinking water consumed per day) of deuterium-depleted drinking water with a concentration of 80ppm as daily drinking water for 90 days, and the second group is treated with normal water as a placebo for a period of time and They will receive the same amount. Clinical and paraclinical tests are recorded before the start of treatment and then 90 days later.

Inclusion criteria: type 2 diabetic patients under oral treatment with HbA1c of 6.5 to 7.5%; no history of autoimmune disease. Exclusion criteria: failure to implement the study protocol and history of electrolyte disturbances.

One group will be treated with 1.5 liters of drinking water depleted of deuterium with a concentration of 80 ppm for a period of 90 days, and the second group will receive normal water as a placebo for the same period and amount.

Liver enzymes; lipid profile; inflammatory markers

Patients are assigned to two groups using the random block method. The number of blocks will be 22 and in each block, two, four or six patients will be included in the study order. Random allocation of blocks of patients to two groups receiving drinking water and receiving water containing deuterium will be done through Sealed Envelope online software. By referring to https://www.sealedenvelope.com/simple-randomiser/v1/lists by specifying the total number of samples, the number of possible samples in each randomized block (2, 4 and 6 patients) randomization by online software is done For example, like the following output: block identifier block size sequence within block treatment 1 2 1 Group B 1 2 2 Group A 2 4 1 Group A 2 4 2 Group B 2 4 3 Group B 2 4 4 Group A 3 2 1 Group A 3 2 2 Group B ... which is the block number, the number of patients in the block, and the random assignment of each patient (with the corresponding number) to the treatment group. The randomized list of blocks will be placed in sealed envelopes and will be provided to the gastroenterologist on a daily basis.

In this study, blinding will be done by coding bottles containing normal water and water depleted of deuterium, which are apparently the same, for the patients as well as part of the researchers who have the role of clinical caregivers and outcome assessors. Then these codes will be put in an envelope according to the number of patients and will be chosen randomly.

Confidentiality and privacy of patients

Study protocol, statistical analysis map, study design, clinical study report will be available

After the publication of the article

Researchers, medical students, professors

If used for future research and in compliance with the principles of referencing

The corresponding author is Dr. Azam Erfani Far erfanifarazam@yahoo.com

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