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

Not Applicable

Completed

• Conditions: Type1 Diabetes; Fasting; Nutrition, Healthy
• Interventions: Dietary Supplement: Whey protein; Dietary Supplement: no Whey protein

• Registration Number: NCT06595550
• Lead Sponsor: King Abdullah International Medical Research Center

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2023-02-01
• Primary Completion: 2023-08-30
• Study Completion: 2023-11-30
• Status Verified: 2024-01
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-11
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
whey protein	Whey protein	whey protein with suhoor
no whey protein	no Whey protein	no whey protein with suhoor

Primary Outcome Measures

Name	Time	Method
Hypoglycemia incidence rate	1 month	number of hypoglycemic events (blood glucose \<70mg/dl) as detected by flash glucose monitoring

Secondary Outcome Measures

Name	Time	Method
Percentage Time-below-range (TBR), time-above-range (TAR), and time-in-range (TIR) prior to and following whey protein consumption 2.	1 month	Glucose profiles as detected by flash glucose monitoring
Glycemic control (HbA1c) and GMI during protein consumption	1 month	glucose parameters detected by flash glucose monitoring by and lab
number of days they needed to brake the fast during each week	1 month	number of days fast broken during each week
Patient preferences through questionnaire	1 month	to compare patient satisfaction

Trial Locations

Locations (1)

King Abdullah International Research Centre; 🇸🇦 Jeddah, Saudi Arabia