| CTRI Number |
CTRI/2011/05/001739 [Registered on: 16/05/2011] Trial Registered Retrospectively |
| Last Modified On: |
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| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
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Public Title of Study
|
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 |
|
Scientific Title of Study
|
Role of oxidative stress and inflammation in type 2 diabetes mellitus-effect of interventions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shreelaxmi Vijay Hegde |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Biochemistry
Srinivas Institute of Medical Science and Research Centre
Mukka,Surathkal,Mangalore
Dakshina Kannada
KARNATAKA
574021
India |
| Phone |
919986668611 |
| Fax |
0824-2442766 |
| Email |
shreelaxmi.hegde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shreelaxmi Vijay Hegde |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Biochemistry
Srinivas Institute of Medical Science and Research Centre
Mukka,Surathkal,Mangalore
Dakshina Kannada
KARNATAKA
574021
India |
| Phone |
919986668611 |
| Fax |
0824-2442766 |
| Email |
shreelaxmi.hegde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreelaxmi Vijay Hegde |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Biochemistry
Srinivas Institute of Medical Science and Research Centre
Mukka,Surathkal,Mangalore
Dakshina Kannada
KARNATAKA
574021
India |
| Phone |
919986668611 |
| Fax |
0824-2442766 |
| Email |
shreelaxmi.hegde@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrShreelaxmi Vijay Hegde |
| Address |
Assistant Professor
Department of Biochemistry
Srinivas Institute of Medical Science and Research Centre
Mukka,Surathkal,Mangalore-574021 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prabha Adhikari |
Kasturba Medical College Hospital |
Attavar, Mangalore-575001
Dakshina Kannada
KARNATAKA |
919880991290
adhikari_pmr@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College Ethics Committee, Mangalore |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 diabetes mellitus, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.yoga
2.diaphragmatic breathing
3.diet rich in antioxidants |
3 months. |
| Comparator Agent |
standard care |
3 months |
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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.) |
|
| ExclusionCriteria |
| Details |
Patients suffering from cancer, pulmonary tuberculosis, rheumatoid arthritis,acute macrovascular disease, infections. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Malondialdehyde (micromol/dl)
2.Reduced glutathione (micromol/gmHb)
3.Vitamin C (mg/dl)
4.Vitamin E (mg/dl)
5.Superoxide dismutase (unit/gmHb)
6.C-reactive protein (mg/L) |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.BMI (kg/m2)
2. Waist circumference (cm)
3. Waist-hip ratio
4. BP (mm/Hg)
5. FPG (mg/dl)
6. PPPG (mg/dl)
7. HbA1c (percentage) |
3 months |
|
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Target Sample Size
|
Total Sample Size="238"
Sample Size from India="238"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/11/2005 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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.
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