ELO Water In Diabetes Care For Enhancement Of Blood Sugar Control

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: ELO Water
* Dietary Supplement: Placebo drinking water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>1.5 L of ELO Water to be drunk daily for 24 weeks | Dietary Supplement: ELO Water<br>* oxygen-enriched water<br>|
| Placebo Comparator: Control Arm<br>1.5 L of placebo bottled drinking water to be drunk daily for 24 weeks | Dietary Supplement: Placebo drinking water<br>* bottled drinking water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of glycaemic control | Reduction in HbA1c and fasting plasma glucose | 12 weeks | 
| Weight loss | Reduction in weight | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxygen-enriched water