Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes
NCT ID: NCT01624116
Last Updated: 2012-06-20
Study Results
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Basic Information
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COMPLETED
NA
161 participants
INTERVENTIONAL
2011-08-31
2011-09-30
Brief Summary
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Detailed Description
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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:
* diet and lifestyle measures alone.
* metformin monotherapy.
* combination therapy with metformin + sulfonylurea.
* combination therapy with metformin + sitagliptin.
* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Diet and lifestyle
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
Metformin monotherapy
Type 2 diabetics on biguanide treatment.
Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Diet and lifestyle
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
Metformin
Patients on metformin monotherapy prior to Ramadan will continue on it, in the same dose
Metformin + Sulphonylurea.
Type 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride.
Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Diet and lifestyle
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
Metformin/ Glimepride
Metformin 500mg and Glimepride 1mg in a combination tablet. Dosage frequency BD
Metformin + Sitagliptin
Type 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin.
Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Diet and lifestyle
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
Metformin/Sitagliptin
Metformin 500 and sitagliptin 50mg in a combination tablet,dosage frequency BD.
Interventions
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Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Diet and lifestyle
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
Metformin
Patients on metformin monotherapy prior to Ramadan will continue on it, in the same dose
Metformin/ Glimepride
Metformin 500mg and Glimepride 1mg in a combination tablet. Dosage frequency BD
Metformin/Sitagliptin
Metformin 500 and sitagliptin 50mg in a combination tablet,dosage frequency BD.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetics on two or less oral hypoglycaemic agents.
Exclusion Criteria
* Pregnancy.
* Serum creatinine \> 1.4 mg/dl.
* Serum ALT \> twice upper limit normal.
* History of pancreatitis, serum amylase \> twice upper limit normal.
* History of intolerance to acarbose.
ALL
No
Sponsors
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Services Hospital, Lahore
OTHER_GOV
Responsible Party
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Dr Saira Burney
Senior Registrar, Endocrinology Unit & Diabetes Management Centre, Services Institute of Medical Sciences,Lahore,Pakistan.
Principal Investigators
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Dr Khadija Irfan, MBBS,FCPS
Role: PRINCIPAL_INVESTIGATOR
Services Hospital.
Locations
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Endocrinology Unit & Diabetes Management Centre, Services Hospital.
Lahore, , Pakistan
Countries
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Other Identifiers
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RT2011
Identifier Type: -
Identifier Source: org_study_id
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