Efficacy and Safety of Modified ORS(Amr and Khulood ORS) in Diabetic Pilgrims During Hajj (AA-HAMS-ORS)

Amr kamel khalil Ahmed

Status: Not yet enrolling

Conditions: Diabetes Mellitus; Heat Stress

Treatments: Other: Standard Oral Rehydration Salts (ORS); Other: Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07618702

Hajj-Diabetes-amr&khulood-V1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Modified ORS Group

Experimental group

Description:

Participants in this group will receive the modified Oral Rehydration Salts ( Amr and khulood ORS) specifically designed for diabetic patients during the Hajj season to prevent dehydration and maintain electrolyte balance.

Treatment:

Other: Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS)

Standard ORS Group

Active Comparator group

Description:

Participants in this group will receive the standard World Health Organization (WHO) Oral Rehydration Salts (ORS) formula.

Treatment:

Other: Standard Oral Rehydration Salts (ORS)