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临床试验/CTRI/2011/05/001739
CTRI/2011/05/001739已完成不适用

Role of oxidative stress and inflammation in type 2 diabetes mellitus-effect of interventions

DrShreelaxmi Vijay Hegde1 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2005年12月11日

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
238
试验地点
1
主要终点
5.Superoxide dismutase (unit/gmHb)

研究概览

简要总结

This study, an open comparative clinical trial was undertaken to evaluate the effect of lifestyle interventions like yoga, diaphragmatic breathing exercise and diet rich in antioxidants in addition to standard care on oxidative stress and inflammation in type 2 diabetes mellitus when compared to standard care only. A total of 238 type 2 diabetes patients were grouped as 60 for yoga, 58 for diaphragmatic breathing, 57 for diet rich in antioxidants and 63 for standard care. 3 months of yoga and diaphragmatic breathing significantly improved BMI, waist-hip ratio (WHR), glycemic control, malondialdehyde, glutathione, vitamin C and CRP levels in diabetics when compared to standard care. The present study also showed that consumption of diet rich in antioxidants in type 2 diabetes result in a significant improvement in WHR, glycemic control, malondialdehyde, glutathione, vitamin C and CRP levels when compared to standard care. There was no change in BMI at the end of dietary intervention. While with diaphragmatic breathing exercise there was a significant reduction in superoxide dismutase (SOD) activity, both yoga and dietary intervention had no effect on SOD levels. All these interventions did not show any effect on waist circumference, BP and vitamin E levels in type 2 diabetes. Thus interventions like yoga, diaphragmatic breathing and diet rich in antioxidants can be employed as effective therapies in reducing the oxidative stress in type 2 diabetes. Due to marginal improvement in BMI, WHR and glycemic control, these interventions can be employed as add-on therapies to standard care in the management of diabetes.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
40.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • type 2 diabetes mellitus (Definition- anybody with a fasting plasma glucose of more than 126mg/dl and a post prandial plasma glucose of greater than 200 mg/dl at onset of diabetes or any known diabetic on oral hypoglycemic agent who did not need insulin therapy for the initial management of diabetes.).

排除标准

  • Patients suffering from cancer, pulmonary tuberculosis, rheumatoid arthritis,acute macrovascular disease, infections.

结局指标

主要结局

5.Superoxide dismutase (unit/gmHb)

时间窗: 3 months

6.C-reactive protein (mg/L)

时间窗: 3 months

1.Malondialdehyde (micromol/dl)

时间窗: 3 months

2.Reduced glutathione (micromol/gmHb)

时间窗: 3 months

4.Vitamin E (mg/dl)

时间窗: 3 months

3.Vitamin C (mg/dl)

时间窗: 3 months

次要结局

  • 1.BMI (kg/m2)(2. Waist circumference (cm))

研究者

发起方
DrShreelaxmi Vijay Hegde
申办方类型
Private medical college

研究点 (1)

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