| CTRI Number |
CTRI/2015/05/005750 [Registered on: 05/05/2015] Trial Registered Retrospectively |
| Last Modified On: |
20/03/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Other (Specify) [Dietary advice] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the impact of supervised weight loss secondary to diet and lifestyle modifications (including yoga) on fat distribution (subcutaneous and visceral fat, which are meaured using CT scan) and insulin resistance (precursor of type 2 diabetes) in adult Indian obese patients |
|
Scientific Title of Study
|
Impact of supervised diet and lifestyle modifications on weight loss, body fat distribution and insulin resistance in adult Indian obese patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajinder Parshad |
| Designation |
Professor of Surgery, |
| Affiliation |
AIIMS |
| Address |
Room no. 5026A, Department of surgical disciplines,
All India Institute of Medical Sciences
South
DELHI
110029
India |
| Phone |
9868397715 |
| Fax |
|
| Email |
rajinder.parshad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kumar Madhavan |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
Dr Kumar Madhavan
Junior Resident
Department of Surgery
5th floor, AIIMS
New Delhi- 110029
Mob- 9555980494
Email- madhavanranjit@gmail.com
South
DELHI
110029
India |
| Phone |
9555980494 |
| Fax |
|
| Email |
madhavanranjit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kumar Madhavan |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
Dr Kumar Madhavan
Junior Resident
Department of Surgery
5th floor, AIIMS
New Delhi- 110029
Mob- 9555980494
Email- madhavanranjit@gmail.com
South
DELHI
110029
India |
| Phone |
9555980494 |
| Fax |
|
| Email |
madhavanranjit@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Room no. 5026A, Department of surgical disciplines,
All India Institute of Medical Sciences, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kumar Madhavan |
AIIMS |
All India Institute of Medical Sciences, New Delhi
Dr. Rajinder Parshad, M.S.,
Professor of Surgery,
Room no. 5026A, Department of surgical disciplines,
All India Institute of Medical Sciences, New Delhi
rajinder.parshad@gmail.com
011-26593462
South
DELHI |
9555980494
madhavanranjit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics sub-committee, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dietary advice, yoga |
Patients are offered dietary advice by a trained dietician and yoga therapy. Patients are given a diet chart based on low calorie diet of 1000-1400 kcal/day depending upon their weight and sex. They are asked to follow up regularly with us for 3 months to ensure compliance. Yoga therapy is given at our hospital for a duration of 1 week at the beginning of the trial. The effect of this is seen on the body weight, insulin resistance and body fat distribution of patients. Patients are contacted via telephone calls. There is no control group. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with obesity, defined as Body Mass Index > 30
|
|
| ExclusionCriteria |
| Details |
1.Patients < 18 years and >60years.
2.Patients with known hypothalamic-pituitary & genetic
causes of obesity
3.Patients who refuse consent for the study
4.Patients, who are on medications that can affect weight
such as thyroxine, steroids.
5.Patients who do not fit into our CT machine. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• To study the impact of supervised dietary changes and lifestyle modifications on weight loss (in kgs over 3 months) in obese Indian adults.
• To study the body fat distribution ( by single cut section of abdomen at L4-L5 disc level) and insulin resistance ( by HOMA IR) in adult Indian obese patients.
• To study the effect of weight loss on insulin resistance and body fat distribution in adult Indian obese patients |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2013 |
| 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="1"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an interventional trial to evaluate the impact of
diet and lifestyle modifications on weight, insulin resistance
and fat distribution of adult Indian obese patients. On initial
evaluation, a detailed history was taken and the following
parameters were noted-
• BMI in kg/m2
• Waist circumference in centimeters
• OGTT in mg/dl
• Fasting insulin levels
• Fat distribution- subcutaneous, visceral and total at L4-
L5 disc level using a single cut section CT scan.
The patients are given dietary consultation by an expert
dietician and followed up regularly. They are also taught
yoga in our hospital for 1 week under the department of
physiology by a trained yoga teacher and then asked to
continue practising at home. These patients are followed up
for 3 months and the above parameters are again noted. |