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CTRI Number  CTRI/2024/02/063079 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 22/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Impact of laparoscopic sleeve gastrectomy surgery on vasoactive mediators in morbid obese patients. 
Scientific Title of Study   Impact of Laparoscopic Sleeve Gastrectomy on vasoactive mediators in patients with morbid obesity. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SUMANTHAREDDY B H  
Designation  Postgraduate resident 
Affiliation  Lady Hardinge Medical College  
Address  Department of surgery S-3 division, Lady Hardinge medical college. New Delhi -110001

New Delhi
DELHI
110001
India 
Phone  9980466785  
Fax    
Email  Sumanthreddy97.sr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. MANOJ ANDLEY 
Designation  Director professor and head of department  
Affiliation  Lady Hardinge Medical College  
Address  Department of surgery S-3 division, Lady Hardinge medical college. New Delhi -110001

New Delhi
DELHI
110001
India 
Phone  9312345379  
Fax    
Email  mandley@hotmail.com  
 
Details of Contact Person
Public Query  
Name  SUMANTHAREDDY B H  
Designation  Postgraduate resident 
Affiliation  Lady Hardinge Medical College  
Address  Department of surgery S-3 division. Lady Hardinge medical college. New Delhi -110001

New Delhi
DELHI
110001
India 
Phone  9980466785  
Fax    
Email  Sumanthreddy97.sr@gmail.com  
 
Source of Monetary or Material Support  
LADY HARDINGE MEDICAL COLLEGE AND ASSOCIATED HOSPITALS 
 
Primary Sponsor  
Name  LADY HARDINGE MEDICAL COLLEGE  
Address  Room number 305, Department of surgery, S-3 division, Lady hardinge medical college, NEW DELHI-110001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SUMANTHAREDDY B H   Lady Hardinge Medical College   Room number 305,Department of surgery, S-3 division, Lady hardinge medical college, New Delhi- 110001
New Delhi
DELHI 		 9980466785

sumanthreddy97.sr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE LADY HARDINGE MEDICALCOLLEGE AND ASSOCIATED HOSPITALS, SHAHID BHAGAT SINGH MARG, NEW DELHI-110001, INDIA.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Laparoscopic sleeve gastrectomy surgery   Surgery done after patient preparation, and pre-op and 3months post-op serum levels of vasoactive mediators are compared 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Morbidly Obese individuals with BMI more than 37.5;
Morbidly Obese individuals with BMI more than 32.5 with comorbidities like hypertension, diabetes mellitus, hypercholesterolemia, non alcoholic fatty liver disease, cardiovascular disease. 
 
ExclusionCriteria 
Details  History of cerebrovascular accident in last 6 months.
Known case of Severe hepatic, cardiac, psychiatric diseases
Known case of Renal artery stenosis and renal disorders.
Patients lost to follow up.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in serum levels of angiotensinogen, renin, aldosterone, and free fatty acids 3 months after laparoscopic sleeve gastrectomy.   Before and 3 months after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To calculate the percentage excess weight loss 3 months after laparoscopic sleeve gastrectomy.
2.To correlate the percentage excess weight loss with the change in serum levels of angiotensinogen, renin, aldosterone and free fatty acids 3 months after laparoscopic sleeve gastrectomy.  		 Before and 3 months after surgery. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   28/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="10" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sumanthreddy97.sr@gmail.com].

  6. For how long will this data be available start date provided 18-01-2024 and end date provided 18-01-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Our study wishes to evaluate the effect of laparoscopic sleeve gastrectomy on vasoactive mediators and percentage excess  weight loss in patients with morbid obesity. Several studies have been done but there is a paucity of literature on this relationship between vasoactive mediators and obesity in Indian population.

Hence, this study aims to determine the effect of laparoscopic sleeve gastrectomy on vasoactive mediators in patients with morbid obesity.

 
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