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Type 2 diabetic patients who fast during Ramadan experience swings in glycaemic control between hypoglycaemic troughs and hyperglycaemic spikes. Hence, the dual challenge in fasting diabetics is to identify which treatment modality leads to the most stable blood glucose levels during a fast and how to smooth out these excursions and reduce risks of fast to a minimum.
Study Objectives:
To compare changes in clinical and metabolic parameters from baseline to the end of four weeks fasting in Ramadan between four treatment arms:
To compare the 24 hour CGMS profile during Ramadan fasting in type 2 diabetic patients before and after addition of acarbose to these pre-existing sub-maximal hypoglycaemic regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet and lifestyle measures alone. | Active Comparator | Type 2 diabetic subjects on lifestyle counselling as part of diabetes treatment would continue as such during Ramadan. They would receive acarbose on one day to be followed by CGMS for a 24 hour period |
|
| Metformin monotherapy | Active Comparator | Type 2 diabetics on biguanide treatment. |
|
| Metformin + Sulphonylurea. | Active Comparator | Type 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride. |
|
| Metformin + Sitagliptin | Active Comparator | Type 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acarbose | Drug | Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight and fructosamine levels during Ramadan fasting. | Change in body weight and fructosamine levels from baseline to end of Ramadan. | 28 days (Average duration of Ramadan fasting) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting lipid profile from baseline to end of Ramadan. | Change in fasting lipid profile from baseline to end of Ramadan. | 28 days(average duration of Ramadan) |
| Change in ghrelin levels from baseline to end of Ramadan. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Khadija Irfan, MBBS,FCPS | Services Hospital. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrinology Unit & Diabetes Management Centre, Services Hospital. | Lahore | Pakistan |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D020909 | Acarbose |
| D004032 | Diet |
| D008687 | Metformin |
| C057619 | glimepiride |
| D000068899 | Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination |
| ID | Term |
|---|---|
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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|
| Diet and lifestyle | Other | Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day |
|
| Metformin | Drug | Patients on metformin monotherapy prior to Ramadan will continue on it, in the same dose |
|
|
| Metformin/ Glimepride | Drug | Metformin 500mg and Glimepride 1mg in a combination tablet. Dosage frequency BD |
|
|
| Metformin/Sitagliptin | Drug | Metformin 500 and sitagliptin 50mg in a combination tablet,dosage frequency BD. |
|
|
Change in ghrelin levels from baseline to end of Ramadan.
| 28days (average duration of Ramadan) |
| Change in renal profile from baseline to end of Ramadan | Change in renal profile from baseline to end of Ramadan. | 28 days(average duration of Ramadan) |
| D004700 | Endocrine System Diseases |
| D009747 |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000068900 | Sitagliptin Phosphate |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |