Diabetes MellitusAA-HAMS-ORSNCT07618702
Efficacy and Safety of Modified ORS(Amr and Khulood ORS) in Diabetic Pilgrims During Hajj
A study testing Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS) and Standard Oral Rehydration Salts (ORS) in people with Diabetes Mellitus and Heat Stress, run by Amr kamel khalil Ahmed at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Heat Stress
- What is being tested?
- Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS) and Standard Oral Rehydration Salts (ORS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Ministry of health
Riyadh
Principal Investigator, +966597310032, drmedahmed@gmail.com
About this study
Official title: Efficacy and Safety of Modified Oral Rehydration Salts (ORS) in Diabetic Pilgrims With Heat Stress and Dehydration During the Hajj Mass Gathering: A Three-Arm, Active-Controlled, Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Heat Stress
- Being tested
- Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS), Standard Oral Rehydration Salts (ORS)
- Medical subject headings
- Diabetes Mellitus, Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS)Other
Modified ORS formula ( Amr and khulood ORS) with adjusted electrolyte and carbohydrate content suitable for diabetic patients to prevent heat-related dehydration.
Standard Oral Rehydration Salts (ORS)Other
Standard World Health Organization (WHO) ORS formula used as an active comparator.
| Study group | Role | What they receive |
|---|---|---|
| Modified ORS Group | Experimental | 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. Receives: Other: Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS) |
| Standard ORS Group | Active comparator | Participants in this group will receive the standard World Health Organization (WHO) Oral Rehydration Salts (ORS) formula. Receives: Other: Standard Oral Rehydration Salts (ORS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 24 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amr kamel khalil Ahmed
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Saudi Arabia
- Responsible party
- Sponsor-investigator, Amr kamel khalil Ahmed, Ministry of Health, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618702
- Sponsor's protocol ID
- Hajj-Diabetes-amr&khulood-V1
- Acronym
- AA-HAMS-ORS
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Modified Oral Rehydration Salts (ORS) in Diabetic Pilgrims With Heat Stress and Dehydration During the Hajj Mass Gathering: A Three-Arm, Active-Controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07618702
- Acronym / sponsor ID
- AA-HAMS-ORS / Hajj-Diabetes-amr&khulood-V1
- Conditions
- Diabetes Mellitus, Heat Stress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Amr kamel khalil AhmedOther government
- Collaborators
- Ministry of Health, Saudi Arabia
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified ORS Group | Experimental | Other: Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS)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. |
| Standard ORS Group | Active comparator | Other: Standard Oral Rehydration Salts (ORS)Participants in this group will receive the standard World Health Organization (WHO) Oral Rehydration Salts (ORS) formula. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified 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. | Other | Modified ORS Group |
| Standard Oral Rehydration Salts (ORS)Standard World Health Organization (WHO) ORS formula used as an active comparator. | Other | Standard ORS Group |
Primary outcome
Change in serum sodium levels from baseline to post-treatment
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS) and Standard Oral Rehydration Salts (ORS) in people with Diabetes Mellitus and Heat Stress, run by Amr kamel khalil Ahmed at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact amr Central Research Office (+966597310032, amrka@moh.gov.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum sodium levels from baseline to post-treatment (time frame: Baseline and 24 hours post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.