Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | 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 | Diabetes, Type 2 |
Intervention | Drug: Acarbose Other: Diet and lifestyle Drug: Metformin Drug: Metformin/ Glimepride Drug: Metformin/Sitagliptin |
Phase | N/A |
Sponsor | Services Hospital, Lahore |
Responsible Party | Services Hospital, Lahore |
ClinicalTrials.gov Identifier | NCT01624116 |
First Received | March 19, 2012 |
Last Updated | June 19, 2012 |
Last verified | June 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | March 19, 2012 |
---|---|
Last Updated Date | June 19, 2012 |
Start Date | August 2011 |
Estimated Primary Completion Date | September 2011 |
Current Primary Outcome Measures | Change in body weight and fructosamine levels during Ramadan fasting. [Time Frame: 28 days (Average duration of Ramadan fasting)] [Designated as safety issue: No]Change in body weight and fructosamine levels from baseline to end of Ramadan. |
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
Brief Title | Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes |
---|---|
Official Title | A Comparison of Four Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetic Patients and the Effect of Add-On Acarbose on Glycaemic Excursions During Ramadan Fasting |
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. |
Detailed Description | 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: - 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. |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Diabetes, Type 2 |
Intervention | Drug: Acarbose Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm. Other Names: *Tab.Glucobay 50mg (Bayer).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: Tablets Glucophage (Merck)Drug: Metformin/ Glimepride Metformin 500mg and Glimepride 1mg in a combination tablet. Dosage frequency BD Other Names: Tablet Getformin 1/500 (Getz Pharma)Drug: Metformin/Sitagliptin Metformin 500 and sitagliptin 50mg in a combination tablet,dosage frequency BD. Other Names: Tab.TreviaMet 50/500 (Getz Pharma) |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
---|---|
Estimated Enrollment | 161 |
Estimated Completion Date | September 2011 |
Estimated Primary Completion Date | September 2011 |
Eligibility Criteria | Inclusion Criteria: - HbA1c 6.5-9.5%. - Type 2 diabetics on two or less oral hypoglycaemic agents. Exclusion Criteria: - Any contraindications either to fasting or to any of the trial medication. - 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. |
Gender | Both |
Ages | N/A |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Pakistan |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01624116 |
---|---|
Other Study ID Numbers | RT2011 |
Has Data Monitoring Committee | No |
Information Provided By | Services Hospital, Lahore |
Study Sponsor | Services Hospital, Lahore |
Collaborators | Not Provided |
Investigators | Principal Investigator: Dr Khadija Irfan, MBBS,FCPS Services Hospital. |
Verification Date | June 2012 |
Locations[ + expand ][ + ]
Endocrinology Unit & Diabetes Management Centre, Services Hospital. | Lahore, Pakistan |
---|