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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Change in body weight and fructosamine levels during Ramadan fasting.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HbA1c 6.5-9.5%.
- •Type 2 diabetics on two or less oral hypoglycaemic agents.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Acarbose (Drug)
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
干预措施: Diet and lifestyle (Other)
Metformin monotherapy
Type 2 diabetics on biguanide treatment.
干预措施: Acarbose (Drug)
Metformin monotherapy
Type 2 diabetics on biguanide treatment.
干预措施: Diet and lifestyle (Other)
Metformin monotherapy
Type 2 diabetics on biguanide treatment.
干预措施: Metformin (Drug)
Metformin + Sulphonylurea.
Type 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride.
干预措施: Acarbose (Drug)
Metformin + Sulphonylurea.
Type 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride.
干预措施: Diet and lifestyle (Other)
Metformin + Sulphonylurea.
Type 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride.
干预措施: Metformin/ Glimepride (Drug)
Metformin + Sitagliptin
Type 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin.
干预措施: Acarbose (Drug)
Metformin + Sitagliptin
Type 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin.
干预措施: Diet and lifestyle (Other)
Metformin + Sitagliptin
Type 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin.
干预措施: Metformin/Sitagliptin (Drug)
结局指标
主要结局
Change in body weight and fructosamine levels during Ramadan fasting.
时间窗: 28 days (Average duration of Ramadan fasting)
Change in body weight and fructosamine levels from baseline to end of Ramadan.
次要结局
- 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.(28days (average duration of Ramadan))
- Change in renal profile from baseline to end of Ramadan(28 days(average duration of Ramadan))
研究者
Dr Saira Burney
Senior Registrar, Endocrinology Unit & Diabetes Management Centre, Services Institute of Medical Sciences,Lahore,Pakistan.
Services Hospital, Lahore