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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dosage therapy | Experimental |
| |
| Regular-dosage therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin and Glimepiride (Low Dosage) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia | Incidence of hypoglycemia | 29 days of Ramadan |
| Hyperglycemia | Incidence of hyperglycemia | 29 days of Ramadan |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetic ketoacidosis | Incidence of diabetic ketoacidosis | 29 days of Ramadan |
| Hyperosmolar hyperglycemic state | Incidence of hyperosmolar hyperglycemic state |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayman A. Zayed, MD | The University of Jordan School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University Hospital | Amman | Amman Governorate | 11942 | Jordan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34305809 | Derived | 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. |
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| Metformin and Vildagliptin (Low Dosage) | Drug |
|
|
| Metformin and Insulin Glargine U100 (Low Dosage) | Drug |
|
|
| Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage) | Drug |
|
|
| Metformin and Glimepiride (Regular Dosage) | Drug |
|
|
| Metformin and Vildagliptin (Regular Dosage) | Drug |
|
|
| Metformin and Insulin Glargine U100 (Regular Dosage) | Drug |
|
|
| Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage) | Drug |
|
|
| 29 days of Ramadan |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D005215 | Fasting |
| D007003 | Hypoglycemia |
| D006943 | Hyperglycemia |
| D016883 | Diabetic Ketoacidosis |
| D006944 | Hyperglycemic Hyperosmolar Nonketotic Coma |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D007662 | Ketosis |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D048909 | Diabetes Complications |
| D003926 | Diabetic Coma |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| C057619 | glimepiride |
| D000077597 | Vildagliptin |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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