Heat stress and dehydration are significant risks for diabetic pilgrims during the Hajj, often leading to severe complications. Standard Oral Rehydration Salts (ORS) are effective for rehydration but may cause hyperglycemia in diabetic patients due to their glucose content. This study aims to evaluate the efficacy and safety of a modified ORS formula ( Amr and khulood ORS) , specifically designed for diabetic individuals, in maintaining hydration without adversely affecting blood glucose levels. The study will involve a randomized controlled trial comparing the modified ORS (Amr and khulood ORS) with standard ORS among diabetic pilgrims experiencing heat stress. Key outcomes include hydration status, electrolyte balance, and glycemic control.
Background: The Hajj pilgrimage involves strenuous physical activity in extreme heat, posing a high risk of dehydration and heat-related illnesses, particularly for diabetic patients. Standard ORS, while lifesaving, contains glucose that can exacerbate hyperglycemia. Objective: To assess whether a modified ORS (Amr and khulood ORS) (with reduced or alternative carbohydrate sources) can safely and effectively rehydrate diabetic pilgrims. Methods: This is a prospective, randomized, double-blind controlled trial. Participants will be diabetic pilgrims presenting with signs of mild to moderate dehydration. They will be randomized to receive either the modified ORS ( Amr and khulood ORS) or the WHO standard ORS. Measurements: Blood glucose levels, serum electrolytes, urine specific gravity, and clinical signs of rehydration will be monitored at baseline and at regular intervals (2, 4, and 6 hours) post-intervention. Safety: Adverse events, including severe hyperglycemia or hypoglycemia, will be recorded. Significance: If proven effective, the modified ORS ( Amr and khulood ORS) could become a standard of care for diabetic individuals in heat-intensive environments, improving safety and health outcomes during Hajj.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
Modified ORS formula ( Amr and khulood ORS) with adjusted electrolyte and carbohydrate content suitable for diabetic patients to prevent heat-related dehydration.
Standard World Health Organization (WHO) ORS formula used as an active comparator.
Ministry of health
Riyadh, Saudi Arabia
Change in serum sodium levels from baseline to post-treatment
Assessment of electrolyte balance by measuring the change in serum sodium levels (mmol/L) after the administration of ORS.
Time frame: Baseline and 24 hours post-treatment
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