Diabetes Mellitus, Heat Stress
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERModified Oral Rehydration Salts (ORS)( Amr and khulood ORS)
Modified ORS formula ( Amr and khulood ORS) with adjusted electrolyte and carbohydrate content suitable for diabetic patients to prevent heat-related dehydration.
OTHERStandard Oral Rehydration Salts (ORS)
Standard World Health Organization (WHO) ORS formula used as an active comparator.
Sponsors
Amr kamel khalil Ahmed
Ministry of Health, Saudi Arabia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diabetic pilgrims attending Hajj. * Age between 18 and 80 years. * Willingness to participate and provide informed consent. * Diagnosis of Type 1 or Type 2 Diabetes Mellitus.
Exclusion criteria
* Patients with severe renal failure. * Patients with acute cardiovascular events. * Patients unable to take oral fluids. * Pregnancy or breastfeeding. * Participation in another clinical trial within the last 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum sodium levels from baseline to post-treatment | Baseline and 24 hours post-treatment | Assessment of electrolyte balance by measuring the change in serum sodium levels (mmol/L) after the administration of ORS. |
Countries
Saudi Arabia
Contacts
CONTACTamr Central Research Office
Outcome results
None listed