| CTRI Number |
CTRI/2009/091/000104 [Registered on: 04/05/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomized double blind active controlled parallel clinical trial to compare the effect of exercises(yogic/walking) on serum insulin level and glycemic control in patients with type 2 diabetes with high and low serum insulin values |
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Scientific Title of Study
|
The effect of various exercises yogic/walking on serum insulin level and glycemic control in patients with type 2 diabetes
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| Trial Acronym |
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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 Tarun Saxena |
| Designation |
|
| Affiliation |
|
| Address |
E-196
Shastri Nagar
Ajmer
RAJASTHAN
305001
India |
| Phone |
0145 2420698 |
| Fax |
-- |
| Email |
yogdiab@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Tarun Saxena |
| Designation |
|
| Affiliation |
Mittal Hospital and research centre pushkar road AJMER |
| Address |
E-196
Shastri Nagar
Ajmer
RAJASTHAN
305001
India |
| Phone |
0145 2420698 |
| Fax |
-- |
| Email |
yogdiab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manjari Saxena |
| Designation |
|
| Affiliation |
|
| Address |
Mittal hospital
Pushkar Road
Ajmer
RAJASTHAN
305001
India |
| Phone |
0145 2603600 |
| Fax |
-- |
| Email |
info@mittalhospital.com |
|
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Source of Monetary or Material Support
|
| KIVI LABS LTD GIDC POR Ramangamdi
BARODA INDIA
0265-2831753 |
|
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Primary Sponsor
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| Name |
NIL |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shyam Somani |
Mittal Hospital |
Pushkar Road,-305001
Ajmer
RAJASTHAN |
01452603601
01452603608
ajmer@mittalhospital.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mittal hospital Ethical commitee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Type 2 diabetes mellitus, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effect of exercises (yogic/walking)on serum insulin and glycemic control |
12 weeks |
| Comparator Agent |
Walking exercise will act as control |
12 weeks |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
Inclusion- Type 2 diabetes(fasting glucose>126mg/dl, duration 1-3 years, interest and some experience of doing yogic exercises(at least 6 months). |
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| ExclusionCriteria |
| Details |
Exclusion-Joint-disorder, diabetic retinopathy, associated severe hypertension, IHD. |
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Method of Generating Random Sequence
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Other |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Change in Fasting serum insulin -increase, decrease, no change, at 12 weeks. |
12 weeks |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| Change in glycemic parameters (blood glucose, glycosylated hemoglobin) and anthropometric measurements, at 12 weeks. |
12 weeks |
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/04/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
The study is a randomized, double blind, parallel group, single centre trial comparing the effect of yogic exercises(predominantly abdominal)and walking(isometric exercise)on serum insulin and glycemic control in patients with type 2 diabetes. The final assessment shall be done after 12 weeks. Initially 100 patients shall be divided into 2 groups on the basis of fasting serum insulin level group 1<27µIU/ml and group 2 >27µIU/ml. Each group will be randomly (numbered from1-50even number will enter into subgroup A and odd number into subgroup B) divided into 2 subgroups. In each group subgroup A will perform yogic exercise and subgroup B walking.The duration will be 30 minutes twice daily for 12 weeks.The primary outcome will be change in serum insulin level and secondary outcome will be change in glycemic parameters and anthropometric data. |