| CTRI Number |
CTRI/2023/05/053003 [Registered on: 22/05/2023] Trial Registered Prospectively |
| Last Modified On: |
22/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
study to evaluate long-term impact of anti-obesity medication |
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Scientific Title of Study
|
SELECT-LIFE -SELECT follow-up study to evaluate Long-term Impact oF anti-obEsity
medication |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EX9536-4750 V3.0 dated 08Dec2022 |
Protocol Number |
| NCT04972721 |
ClinicalTrials.gov |
| U1111-1255-5644 |
UTN |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Maya Sharma |
| Designation |
Senior Director- Clinical, Medical and Regulatory |
| Affiliation |
Novo Nordisk India Private Ltd. |
| Address |
Novo Nordisk India Private Ltd.
Plot No. 32,47 - 50, EPIP Area, Whitefield, Bangalore- 560066, Karnataka, India
Bangalore
KARNATAKA
560066
India |
| Phone |
9911497869 |
| Fax |
|
| Email |
YRMS@novonordisk.com |
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Details of Contact Person
Public Query
|
| Name |
Jeevan Robero |
| Designation |
Sr. Site Activation Specialist |
| Affiliation |
Syneos Health |
| Address |
Syneos Health
Block N1, 2nd Floor, Manyata Embassy Business Park,
Outer Ring Road, Nagawara, Bengaluru – 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9620029341 |
| Fax |
|
| Email |
jeevan.robero@syneoshealth.com |
|
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Source of Monetary or Material Support
|
| Novo Nordisk, Novo Allé, 2880 Bagsvaerd, Denmark |
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Primary Sponsor
|
| Name |
Novo Nordisk |
| Address |
Novo Allé, 2880 Bagsvaerd, Denmark |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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Countries of Recruitment
|
Algeria
Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Colombia
Croatia
Denmark
Finland
France
Germany
Greece
Hungary
India
Ireland
Italy
Japan
Latvia
Malaysia
Mexico
Netherlands
Portugal
Russian Federation
Serbia
South Africa
Spain
Sweden
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Upendra Kaul |
Batra Hospital and Medical Research Centre |
Research department, 1, Tughlakabad Institutional Area, Mehrauli Badarpur Road, New Delhi-110062
New Delhi
DELHI |
9811150518
upendra.kaul@batrahospitaldelhi.org |
| Dr Satbir Singh |
BLK Heart Centre |
BLK Super Speciality Hospital, Clinical Research department,
Pusa Road, New Delhi-110005
New Delhi
DELHI |
9717456667
satbir.singh@blkhospital.com |
| Dr Ajay Naik |
Care Institute of Medical Sciences |
Plot no 67/1, research department,
Near Shakun Mall,Opp.Panchamrut Bunglows.
Off Science Road, Sola, Ahmedabad- 380060,
Gujarat, India
Ahmadabad
GUJARAT |
9825082666
naikajay@yahoo.com |
| Dr Nihal Thomas |
Christian Medical College |
810, Dept of Endocrinology Diabetes & Metabolism,
Christian Medical College,
Vellore-4,India
Vellore
TAMIL NADU |
9843111996
nihal_thomas@yahoo.com |
| Dr Gurpreet S Wander |
Dayanand Medical College & Hospital |
Clinical Research department, Unit Hero DMC Heart Institute, Tagore nagar, Civil lines, Ludhiana- 141001
Ludhiana
PUNJAB |
9815545316
drgswander@yahoo.com |
| Dr Rishi Sethi |
Gandhi Memorial Hospital King Georges Medical University |
Clinical Research department, Erstwhile Chhatrapati Shahuji Maharaj Medical University
Chowk, Lucknow
Lucknow
UTTAR PRADESH |
9415084949
drrishisethi1@gmail.com |
| Dr Sanjay Mittal |
Medanta The Medicity |
Research Department, Sector -38, Gurugram -122001, Haryana
Gurgaon
HARYANA |
01244141414
sanjay.mittal@medanta.org |
| Dr Piyush Desai |
Nirmal Hospital Pvt Ltd |
Nirmal Hospital, Clinical Research department, Sagrampura, Surat, Gujarat 395002
Surat
GUJARAT |
9825144453
drpiyushdesai@gmail.com |
| Dr KMK Reddy |
Osmania General Hospital |
Research wing department, Begum Bazar, Afzal Gunj, Hyderabad, Telangana 500012
Hyderabad
TELANGANA |
9848015098
drkmkreddyp@yahoo.com |
| Dr D K Agarwal |
Sardar Patel Medical College and Hospital |
Department of Cardiology,
Bikaner- 334003, Rajasthan, India
Bikaner
RAJASTHAN |
9829217899
tippy1234@rediffmail.com |
| Dr Atul Abhyankar |
Shri B D Mehta Mahavir Heart Institute |
Shree Mahavir Campus, Clinical Research department, Athwagate, Ring Road, Surat- 395001, Gujarat, India
Surat
GUJARAT |
9824145738
heartfirst.surat@gmail.com |
| Dr Mahesh Fulwani |
Shrikrishna Hrudayalaya and Critical Care Centre |
Deaprtment of Cardiology, Tikekar Road, Congress Nagar, Square, Nagpur, Maharashtra 440012
Nagpur
MAHARASHTRA |
9823078146
drmaheshfulwani@gmail.com |
| Dr Devang M Desai |
Unicare Heart Institute and Research Centre |
Clinical Research department, Acme Plaza, B-Wing, Near Sosyo Circle, Canal Road, Surat- 395002, Gujarat, India
Surat
GUJARAT |
9824152979
hridayamheartcare@gmail.com |
| Dr Sandeep Bansal |
Vardhman Mahavir Medical College and Safdarjung Hospital |
near AIIMS Hospital, Research department, Ansari Nagar West, New Delhi-110029.
New Delhi
DELHI |
9810543368
drsbansal2000@yahoo.com |
| Dr Vinod Vijan |
Vijan Cardiac & Critical Care |
Dr Vijan Hospital Marg, Clinical Research department, College Road, Nashik, Maharashtra 422005, India
Nashik
MAHARASHTRA |
9822025353
vmvijan@hotmail.com |
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Details of Ethics Committee
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Dr. B L Kapur Memorial Hospital Ethics Committee |
Submittted/Under Review |
| Drug Trial Ethics Committee |
Submittted/Under Review |
| Ethics Committee of Care Institute of Medical Sciences |
Submittted/Under Review |
| Ethics Committee- S.P. Medical College & A.G of Hospitals |
Submittted/Under Review |
| Institutional Ethics Committee - Osmania Medical College |
Approved |
| Institutional Ethics Committee - VMMC and SJH |
Submittted/Under Review |
| Institutional Ethics Committee for Human Research |
Submittted/Under Review |
| Institutional Review Board (IRB) of the Christian Medical College (CMC) |
Submittted/Under Review |
| Medanta Institutional Ethics Committee |
Submittted/Under Review |
| Nirmal Hospital Pvt Ltd Ethics Committee |
Approved |
| Scientific Research and Ethical Review Committee |
Approved |
| Shri B D Mehta Mahavir Heart Institute Ethics Committee |
Submittted/Under Review |
| Unity Hospital Ethics Committee |
Approved |
| Vijan Hospital Ethics Commitee |
Approved |
| Virtuous Institutional Medical Research Ethics Committee |
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 |
(1) ICD-10 Condition: E668||Other obesity, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Randomized into the SELECT clinical trial (EX9536-4388) and has not withdrawn consent, regardless of level of participation, dose achieved or treatment discontinuation.
2) Signed SELECT-LIFE consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). |
|
| ExclusionCriteria |
| Details |
1) Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Time to all-cause death |
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Approximately- 521 week |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Time to first occurrence of a composite consisting of: All-cause death, non-fatal myocardial infarction and non-fatal stroke |
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)Approximately- 521 week |
| Time to first occurrence of non-fatal myocardial infarction |
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)Approximately- 521 week |
| Time to first occurrence of non-fatal stroke |
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week |
| Time to diagnosis of type 2 diabetes |
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week |
| Time to first occurrence of any type of cancer |
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week |
| Time to first occurrence of a composite of obesity related cancer defined by WHO |
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week |
| Time to first occurrence of knee replacement |
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week |
| Time to first occurrence of bariatric surgery |
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week |
| Time to first occurrence of anti-obesity medical treatment |
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week |
| Time to first occurrence of use of continuous positive airways pressure (CPAP) device |
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week |
| Total number of myocardial infarctions |
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week |
| Total number of strokes |
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months) Approximately- 521 week |
| Change in body weight from V-EOT (is the end of treatment visit in SELECT) to biannual assessments, (year 1-10) |
From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months) Approximately- 521 week |
| Change in Patient reported quality of life questionnaire (EQ-5D-5L) from V-EOT (is the end of treatment visit in SELECT) to biannual assessments, (year 1-10) |
From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months) Approximately- 521 week |
| Total Days of hospitalisation from P-FU (is the end of trial visit in SELECT) to biannual assessments, (year 1-10) |
From P-FU(is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months) Approximately- 521 week |
|
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Target Sample Size
|
Total Sample Size="12450"
Sample Size from India="491"
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)
|
07/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/11/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="10"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Not Applicable |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Participants are being asked to participate in SELECT-LIFE study because participants take part in the SELECT trial. SELECT-LIFE study is a survey-based study that will start when the SELECT trial ends. SELECT-LIFE looks at the long-term effects of participants taking part in the SELECT trial including the trial medicine participants have been taking. When the SELECT trial ends, participants will no longer get the medicine participants got in the study, even if participants decide to take part in the SELECT-LIFE study. Participants will not get any specific treatment or medicine as part of the SELECT-LIFE study, and participants will be treated as participants normally would by their own doctor. The SELECT-LIFE study will last for up to 10 years after SELECT trial ends, and participants will be asked to fill in a questionnaire about their health every 6 months.
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