The Effect of Whey Protein Consumption on Hypoglycemia in Adults with Type 1 Diabetes During Fasting Ramadan.

NCT ID: NCT06595550

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Cross over randomized design for adding whey protein to Suhoor meal for patients with T1DM during fasting Ramadan

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients with type1 diabetes who intend to fast will be supplied with dietary supplement "Whey protein" to be taken with Suhoor (predawn meal) for one week during Ramadan. They will be then crossed over to not taking the whey protein for another week. the order of taking whey protein will be randomized.

During both weeks patients will be monitored through flash continuous glucose monitoring and data will be compared in regards to incidence and timing of hypoglycemia, hyperglycemia, and time in target range.

After Ramadan data will be collected on number of days they had to brake fast due to low blood sugar during both weeks and overall satisfaction with using whey protein during Ramadan.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type1 Diabetes Fasting Nutrition, Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

whey protein

whey protein with suhoor

Group Type EXPERIMENTAL

Whey protein

Intervention Type DIETARY_SUPPLEMENT

Powder milk

no whey protein

no whey protein with suhoor

Group Type PLACEBO_COMPARATOR

no Whey protein

Intervention Type DIETARY_SUPPLEMENT

Powder milk

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Whey protein

Powder milk

Intervention Type DIETARY_SUPPLEMENT

no Whey protein

Powder milk

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Type 1 Diabetes Mellitus
2. Age \>14 years
3. Committed to do Regular SMBG or on CGM
4. On Multiple Daily Injections or insulin pumps
5. On carbohydrate counting for meal dosing
6. Have previously fasted Ramadan
7. willing to fast Ramadan this year
8. Well-educated about requirements for fasting Ramadan

Exclusion Criteria

1. Hypoglycemia unawareness
2. Cognitive impairment or learning disability
3. Renal and hepatic impairment
4. Adrenal insufficiency
5. Pregnancy
6. Alcohol consumption
7. Any diagnosed psychiatric disease
8. Sensor-augmented insulin pumps
9. HbA1c \>12%
10. Already on protein supplements
Minimum Eligible Age

14 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King Abdullah International Medical Research Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Reem Alamoudi, MD

Role: PRINCIPAL_INVESTIGATOR

Ministry of National Guard Health Affairs

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

King Abdullah International Research Centre

Jeddah, , Saudi Arabia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Saudi Arabia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ICT23J/001/01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dietary Protein Sources and Glycemic Variability
NCT06525441 NOT_YET_RECRUITING NA