Clinical trial NCT04237493: Dosage Reduction and Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan
Official title: Effect of Dosage Reduction of Glucose-Lowering Multidrug Regimens on the Incidence of Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan: An Open-Label, Parallel-Group, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Fasting
Hypoglycemic Agents
Hypoglycemia
Hyperglycemia
Diabetic Ketoacidosis
Hyperglycemic Hyperosmolar Nonketotic Coma
Metformin
Glimepiride
Vildagliptin
Insulin Glargine
Insulin, Regular, Human
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 687
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hypoglycemia
timeFrame: 29 days of Ramadan
measure: Hyperglycemia
timeFrame: 29 days of Ramadan
Secondary outcomes:
measure: Diabetic ketoacidosis
timeFrame: 29 days of Ramadan
measure: Hyperosmolar hyperglycemic state
timeFrame: 29 days of Ramadan
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
state: Amman Governorate
Study officials:
affiliation: The University of Jordan School of Medicine
name: Ayman A. Zayed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zaghlol LY, Beirat AF, Amarin JZ, Hassoun Al Najar AM, Hasan YY, Qtaishat A, Tierney ME, Zaghlol RY, Zayed AA. Effect of Dosage Reduction of Hypoglycemic Multidrug Regimens on the Incidences of Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan: A Randomized Controlled Trial. Front Endocrinol (Lausanne). 2021 Jul 7;12:613826. doi: 10.3389/fendo.2021.613826. eCollection 2021.