Fasting, Nutrition, Healthy, Type1 Diabetes
Conditions
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.
Interventions
DIETARY_SUPPLEMENTWhey protein
Powder milk
DIETARY_SUPPLEMENTno Whey protein
Powder milk
Sponsors
King Abdullah International Medical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia incidence rate | 1 month | number of hypoglycemic events (blood glucose \<70mg/dl) as detected by flash glucose monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient preferences through questionnaire | 1 month | to compare patient satisfaction |
| number of days they needed to brake the fast during each week | 1 month | number of days fast broken during each week |
| 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 |
Countries
Saudi Arabia
Outcome results
None listed