The Effect of Whey Protein Consumption on Hypoglycemia in Adults with Type 1 Diabetes During Fasting Ramadan.
1 other identifier
interventional
44
1 country
1
Brief Summary
Cross over randomized design for adding whey protein to Suhoor meal for patients with T1DM during fasting Ramadan
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedFirst Submitted
Initial submission to the registry
January 2, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedSeptember 19, 2024
January 1, 2024
7 months
January 2, 2024
September 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Hypoglycemia incidence rate
number of hypoglycemic events (blood glucose \<70mg/dl) as detected by flash glucose monitoring
1 month
Secondary Outcomes (4)
Percentage Time-below-range (TBR), time-above-range (TAR), and time-in-range (TIR) prior to and following whey protein consumption 2.
1 month
Glycemic control (HbA1c) and GMI during protein consumption
1 month
number of days they needed to brake the fast during each week
1 month
Patient preferences through questionnaire
1 month
Study Arms (2)
whey protein
EXPERIMENTALwhey protein with suhoor
no whey protein
PLACEBO COMPARATORno whey protein with suhoor
Interventions
Eligibility Criteria
You may qualify if:
- Type 1 Diabetes Mellitus
- Age \>14 years
- Committed to do Regular SMBG or on CGM
- On Multiple Daily Injections or insulin pumps
- On carbohydrate counting for meal dosing
- Have previously fasted Ramadan
- willing to fast Ramadan this year
- Well-educated about requirements for fasting Ramadan
You may not qualify if:
- Hypoglycemia unawareness
- Cognitive impairment or learning disability
- Renal and hepatic impairment
- Adrenal insufficiency
- Pregnancy
- Alcohol consumption
- Any diagnosed psychiatric disease
- Sensor-augmented insulin pumps
- HbA1c \>12%
- Already on protein supplements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Abdullah International Research Centre
Jeddah, Saudi Arabia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reem Alamoudi, MD
Ministry of National Guard Health Affairs
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2024
First Posted
September 19, 2024
Study Start
February 1, 2023
Primary Completion
August 30, 2023
Study Completion
November 30, 2023
Last Updated
September 19, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share