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NCT Number: NCT04127890

ELO Water In Diabetes Care For Enhancement Of Blood Sugar Control

This double-blinded, randomised and controlled trial evaluates the efficacy of oxygen-enriched ELO drinking water as an adjuvant modality in diabetes care for enhancement of glycemic control in patients with Type 2 diabetes mellitus. Adults with type 2 diabetes will be randomized to drink 1.5 L of either ELO water or normal drinking water for 24 weeks. The primary outcome is improvement in glycaemic control.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changi General Hospital

Singapore, 529889

About this study

Global diabetes mellitus prevalence is rapidly increasing. In 2015, IDF reported that Singapore has 12.8% of its population diagnosed with diabetes mellitus, of which more than 90 percent are type 2 diabetes with underlying insulin resistance. With the aging population and increasing prevalence of obesity and sedentary lifestyles, the prevalence is expected to continue to rise.

In vitro studies demonstrated that hypoxia creates a state of insulin resistance through HIF (Hypoxia Inducible Factor) transcription factor expression in adipocytes. Insulin sensitivity was shown to improve in type 2 diabetes patients and overweight non diabetic patients placed in a hyperbaric oxygen chamber.Increased water intake has been associated with lower HbA1c in the general population , and also with lower post-prandial glucose in type 2 diabetic individuals.

This study aims to evaluate the effects of 1.5 L daily of ELO water, a drinking water enriched with molecular oxygen in a stable form, with a similar volume of bottled drinking water, on glycaemic control in adults with type 2 diabetes in Singapore.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Type 2 diabetes mellitus with HbA1c 8.0% to 11%, within the last 6 months

Exclusion criteria

  • Type 1 diabetes patients
  • Pregnant or lactating women
  • Comorbid conditions requiring fluid restriction to below 1.5 L daily
  • Terminal illness with life expectancy less than 1 year

Treatment and study plan

ELO Water

Dietary Supplement

oxygen-enriched water

Placebo drinking water

Dietary Supplement

bottled drinking water

Primary outcomes

  1. Improvement of glycaemic control

    Time frame: 12 weeks

    Reduction in HbA1c and fasting plasma glucose

  2. Weight loss

    Time frame: 12 weeks

    Reduction in weight

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Collaborators

  • ELO Water Pte. Ltd.

Registry information

Official study title

ELO Water In Diabetes Care For Enhancement Of Blood Sugar Control (EDEN Study) - A Double-Blinded Randomized Controlled Trial

Acronym: EDEN

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 16, 2019
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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