Low Carbohydrate Diet for Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 主要终点
- The reduction of medication effect score (MES)
研究概览
简要总结
This study determines whether an educational intervention with a 90 g/day LCD is safe, effective and has good compliance for poorly controlled type 2 diabetes patients.
详细描述
Poorly controlled type 2 diabetic men and women, aged between 20 and 80 years, with HbA1c≧ 7.5% (58mmol/mol) in the previous 3 months participated in this randomized controlled 18-month trial at a medical center. Patients were randomly assigned to the interventional group and given a 90g/day low carbohydrate diet (LCD) or the controlled group, which maintained a standard calorie-restricted diet (CRD). All patients received periodic educational intervention and were monitored for weight, body composition, waist girth, hip girth, thigh girth, pre- and post-prandial serum glucose, HbA1c, lipid profile(Cholesterol, Triglyceride. HDL, LDL, sdLDL), renal function, microalbumin/cre, carotid intima-media thickness (IMT),and medication effect score (MES).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes diagnosis ≧ 1 year
- •poorly controlled with HbA1c≧ 7.5% in the previous 3 months.
- •aged 20 to 80
- •without or with treatment [ oral hypoglycemic agents (OHA) and/or insulin treatment)
排除标准
- •pregnancy or lactating women
- •impaired renal function with serum creatinine ≧ 1.5 mg/dl
- •abnormal liver function [alanine aminotransferase (ALT), aspartate aminotransferase (AST), ≧ 3 times the normal upper limit) or liver cirrhosis
- •significant heart diseases (unstable angina, unstable heart failure)
- •frequent gout attacks (≧ 3 times/year)
- •participation in other weight loss programs or the use of weight-reducing drugs
- •eating disorders
- •could not complete the questionnaire
- •poor compliance to protocol.
研究组 & 干预措施
Low carbohydrate diet
Low carbohydrate diet limits carbohydrate <=90g/day
干预措施: Low carbohydrate diet (Dietary Supplement)
Calori restricted diet
Traditional diabetic diet
干预措施: Calori restricted diet (Dietary Supplement)
结局指标
主要结局
The reduction of medication effect score (MES)
时间窗: measured at baseline and every 3 months for 18 months after intervention
The MES assessed the overall utilization of hypoglycemic agents. The percentage of the maximum daily dose for each medication was multiplied by an adjustment factor and these products were summed to produce the final MES value. A higher MES value denoted a greater use of medication. The minimum score is 0 and without maximum score.The lower, the better. The reduction of MES over the 18 months after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
The improvement of glycemic control status
时间窗: measured at baseline and every 3 months for 18 months after intervention
The reduction of HbA1c, fasting and 2-h glucose over the 18 months after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
次要结局
- The improvement of small dense low density lipoprotein (sdLDL)(measured at baseline and every 6 months for 18 months after intervention)
- The improvement of lipid profile(measured at baseline and every 3 months for 18 months after intervention)
- The improvement of microalbuminuria.(measured at baseline and 18 month after intervention)
- The improvement of carotid intima-media thickness (IMT)(measured at baseline and 18 month after intervention)
- The maintenance of renal function(measured at baseline and every 3 months for 18 months after intervention)