Dosage Reduction and Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan
Phase 4
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage)Drug: Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage)
- Registration Number
- NCT04237493
- Lead Sponsor
- University of Jordan
- Brief Summary
Every lunar year, during the month of Ramadan, Muslims abstain from food and drink between dawn and nightfall. People with type 2 diabetes who fast during Ramadan are at an increased risk of acute glycemic complications. Our aim is to investigate the effect of dosage reduction of four glucose-lowering multidrug regimens on the incidence of acute glycemic complications in people with type 2 diabetes who fast during Ramadan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 687
Inclusion Criteria
- Prospective participant is a returning patient with type 2 diabetes;
- Prospective participant expressed an intention to fast during Ramadan;
- Prospective participant has been compliant with one of four glucose-lowering multidrug regimens for at least the past three months.
Exclusion Criteria
- Prospective participant is a pregnant, postpartum, breastfeeding, or eumenorrheic woman;
- Prospective participant has experienced diabetic ketoacidosis or hyperosmolar hyperglycemic state within three months;
- Prospective participant has received niacin or corticosteroids within one month; and,
- Prospective participant has any history of recurrent hypoglycemia, hypoglycemia unawareness, chronic renal insufficiency (stages IV or V), liver cirrhosis, uncontrolled epilepsy, depressive disorder, bipolar disorder, psychotic disorder, or cognitive dysfunction.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Regular-dosage therapy Metformin and Vildagliptin (Regular Dosage) - Low-dosage therapy Metformin and Vildagliptin (Low Dosage) - Regular-dosage therapy Metformin and Glimepiride (Regular Dosage) - Regular-dosage therapy Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage) - Regular-dosage therapy Metformin and Insulin Glargine U100 (Regular Dosage) - Low-dosage therapy Metformin and Glimepiride (Low Dosage) - Low-dosage therapy Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage) - Low-dosage therapy Metformin and Insulin Glargine U100 (Low Dosage) -
- Primary Outcome Measures
Name Time Method Hyperglycemia 29 days of Ramadan Incidence of hyperglycemia
Hypoglycemia 29 days of Ramadan Incidence of hypoglycemia
- Secondary Outcome Measures
Name Time Method Diabetic ketoacidosis 29 days of Ramadan Incidence of diabetic ketoacidosis
Hyperosmolar hyperglycemic state 29 days of Ramadan Incidence of hyperosmolar hyperglycemic state
Trial Locations
- Locations (1)
Jordan University Hospital
🇯🇴Amman, Amman Governorate, Jordan
Jordan University Hospital🇯🇴Amman, Amman Governorate, Jordan