A clinical trial to study the effect of lifestyle interventions-yoga, diaphragmatic breathing and diet rich in antioxidants on oxidative stress and inflammation in type 2 diabetes mellitus

Completed

• Conditions: Type 2 diabetes mellitus

• Registration Number: CTRI/2011/05/001739
• Lead Sponsor: DrShreelaxmi Vijay Hegde

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-11

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

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.).

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.Reduced glutathione (micromol/gmHb)	3 months
4.Vitamin E (mg/dl)	3 months
3.Vitamin C (mg/dl)	3 months
5.Superoxide dismutase (unit/gmHb)	3 months
6.C-reactive protein (mg/L)	3 months
1.Malondialdehyde (micromol/dl)	3 months

Secondary Outcome Measures

Name	Time	Method
1.BMI (kg/m2)	2. Waist circumference (cm)

Trial Locations

Locations (1)

Kasturba Medical College Hospital; 🇮🇳 Kannada, KARNATAKA, India

Kasturba Medical College Hospital

🇮🇳Kannada, KARNATAKA, India

Dr Prabha Adhikari

Principal investigator

919880991290

adhikari_pmr@yahoo.com