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OpenTrials
Completed

NCT Number: NCT06595550

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

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

Completed

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Key information

Age range

14 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdullah International Research Centre

Jeddah, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Whey Protein

Dietary Supplement

Powder milk

no Whey protein

Dietary Supplement

Powder milk

Primary outcomes

  1. Hypoglycemia incidence rate

    Time frame: 1 month

    number of hypoglycemic events (blood glucose <70mg/dl) as detected by flash glucose monitoring

Secondary outcomes

  1. Percentage Time-below-range (TBR), time-above-range (TAR), and time-in-range (TIR) prior to and following whey protein consumption 2.

    Time frame: 1 month

    Glucose profiles as detected by flash glucose monitoring

  2. Glycemic control (HbA1c) and GMI during protein consumption

    Time frame: 1 month

    glucose parameters detected by flash glucose monitoring by and lab

  3. number of days they needed to brake the fast during each week

    Time frame: 1 month

    number of days fast broken during each week

  4. Patient preferences through questionnaire

    Time frame: 1 month

    to compare patient satisfaction

Sponsors and collaborators

Lead sponsor

King Abdullah International Medical Research Center

Other

Registry information

Official study title

The Effect of Whey Protein Consumption on Hypoglycemia in Adults with Type 1 Diabetes During the Fasting Holy Month of Ramadan: a Randomized, Crossover Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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