Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Study Objectives:
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To compare changes in clinical and metabolic parameters from baseline to the end of four weeks fasting in Ramadan between four treatment arms:
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diet and lifestyle measures alone.
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metformin monotherapy.
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combination therapy with metformin + sulfonylurea.
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combination therapy with metformin + sitagliptin.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Diet and lifestyle measures alone. 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 |
Drug: Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Other Names:
Other: Diet and lifestyle
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
|
| Active Comparator: Metformin monotherapy Type 2 diabetics on biguanide treatment. |
Drug: Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Other Names:
Other: Diet and lifestyle
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
Drug: Metformin
Patients on metformin monotherapy prior to Ramadan will continue on it, in the same dose
Other Names:
|
| Active Comparator: Metformin + Sulphonylurea. Type 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride. |
Drug: Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Other Names:
Other: Diet and lifestyle
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
Drug: Metformin/ Glimepride
Metformin 500mg and Glimepride 1mg in a combination tablet. Dosage frequency BD
Other Names:
|
| Active Comparator: Metformin + Sitagliptin Type 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin. |
Drug: Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Other Names:
Other: Diet and lifestyle
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
Drug: Metformin/Sitagliptin
Metformin 500 and sitagliptin 50mg in a combination tablet,dosage frequency BD.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in body weight and fructosamine levels during Ramadan fasting. [28 days (Average duration of Ramadan fasting)]
Change in body weight and fructosamine levels from baseline to end of Ramadan.
Secondary Outcome Measures
- Change in fasting lipid profile from baseline to end of Ramadan. [28 days(average duration of Ramadan)]
Change in fasting lipid profile from baseline to end of Ramadan.
- Change in ghrelin levels from baseline to end of Ramadan. [28days (average duration of Ramadan)]
Change in ghrelin levels from baseline to end of Ramadan.
- Change in renal profile from baseline to end of Ramadan [28 days(average duration of Ramadan)]
Change in renal profile from baseline to end of Ramadan.
Eligibility Criteria
Criteria
Inclusion Criteria:
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HbA1c 6.5-9.5%.
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Type 2 diabetics on two or less oral hypoglycaemic agents.
Exclusion Criteria:
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Any contraindications either to fasting or to any of the trial medication.
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Pregnancy.
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Serum creatinine > 1.4 mg/dl.
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Serum ALT > twice upper limit normal.
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History of pancreatitis, serum amylase > twice upper limit normal.
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History of intolerance to acarbose.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Endocrinology Unit & Diabetes Management Centre, Services Hospital. | Lahore | Pakistan |
Sponsors and Collaborators
- Services Hospital, Lahore
Investigators
- Principal Investigator: Dr Khadija Irfan, MBBS,FCPS, Services Hospital.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RT2011