Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes, Type 2
• Interventions: Drug: Acarbose; Other: Diet and lifestyle; Drug: Metformin/Sitagliptin; Drug: Metformin/ Glimepride; Drug: Metformin

• Registration Number: NCT01624116
• Lead Sponsor: Services Hospital, Lahore

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 Timeline

• Study Start: 2011-08
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2012-03-19
• Status Verified: 2012-06
• Study First Submitted QC: 2012-06-19
• Last Update Submitted: 2012-06-19
• Study First Posted: 2012-06-20
• Last Update Posted: 2012-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin + Sitagliptin	Diet and lifestyle	Type 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin.
Metformin + Sitagliptin	Metformin/Sitagliptin	Type 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin.
Diet and lifestyle measures alone.	Diet and lifestyle	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	Diet and lifestyle	Type 2 diabetics on biguanide treatment.
Metformin + Sulphonylurea.	Diet and lifestyle	Type 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride.
Metformin + Sulphonylurea.	Metformin/ Glimepride	Type 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride.
Diet and lifestyle measures alone.	Acarbose	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	Acarbose	Type 2 diabetics on biguanide treatment.
Metformin monotherapy	Metformin	Type 2 diabetics on biguanide treatment.
Metformin + Sulphonylurea.	Acarbose	Type 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride.
Metformin + Sitagliptin	Acarbose	Type 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Endocrinology Unit & Diabetes Management Centre, Services Hospital.; 🇵🇰 Lahore, Pakistan