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CTRI Number  CTRI/2022/06/043026 [Registered on: 06/06/2022] Trial Registered Prospectively
Last Modified On: 31/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Occurence of prediabetes among young adult in mizoram 
Scientific Title of Study   Prevalence of Prediabetes among young adult and Evaluation of the Demographic factors Associated with Prediabetes  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lalchhanhinmi 
Designation  Ph.D ( Nursing) Scholar 
Affiliation  Mizoram University 
Address  Department of Life Science Mizoram University Tanhril Aizawl Mizoram
Department of Life Science Mizoram University Tanhril Aizawl Mizoram
Aizawl
MIZORAM
796009
India 
Phone  9436152287  
Fax    
Email  chhanifanai72@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Elsa Sanatombi Devi 
Designation  Professor 
Affiliation  Manipal university 
Address  Department of Medical Surgical Nursing Manipal College of Nursing Manipal Academy of Higher Education
Department of Medical Surgical Nursing Manipal College of Nursing Manipal Academy of Higher Education 576104
Udupi
KARNATAKA
576104
India 
Phone  9739864293  
Fax    
Email  sanatombi2010@gmail.com  
 
Details of Contact Person
Public Query  
Name  Gurusawami Gurusubramanian 
Designation  Professor 
Affiliation  Mizoram mizoram University 
Address  Room No 1 Department of Zoology Life science Mizotam University,Tanhril Aizawl,
Room No 1 Department of Zoology Life science Mizotam University,Tanhril Aizawl,
Aizawl
MIZORAM
796009
India 
Phone  9436152287  
Fax    
Email  mzut036@mzu.edu.in  
 
Source of Monetary or Material Support  
Health and wellness cerntres Urban areas- Electric Veng Bawngkawn, Zuangtui ,Dinthar,Chaltlang and Rural areas Health and wellness Centres Muallungthu,Tlungvel,Zohmun and Sumsuih 
 
Primary Sponsor  
Name  Lalchhanhimi 
Address  Principal, Mizoram College of Nursing, Falkawn, aizawl, Mizoram 
Type of Sponsor  Other [Self] 
 
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 
Lalchungnunga  Health and Wellness Centres  Director Health SErvices Department of Health and family welfare Government of Mizoram MINECO
Aizawl
MIZORAM 		 8414828592

dhsmizoram@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee, Mizoram University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Young adult between 20-40 years of age 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Young adult who are willing to participate in the study.
2. Young adult who can read and write.
3. Young adult who has not been diagnosed with Diabetes Mellitus.
 
 
ExclusionCriteria 
Details  1. Young adult who are not willing to participate in the study.
2. Young adult who cannot read and write.
3. Young adult who has been diagnosed with Diabetes Mellitus.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Identifying prevalence of prediabetes among 20-40 years in urban and rural areas
2. Identifying the associated factors of prediabetes for prevention of progression to Diabetes Mellitus 		 6 years 
 
Secondary Outcome  
Outcome  TimePoints 
Identifying prevalence of prediabetes among 20-40 years in urban and rural areas
2. Identifying the associated factors of prediabetes for prevention of progression to Diabetes Mellitus 		 4 years 
 
Target Sample Size   Total Sample Size="820"
Sample Size from India="820" 
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   N/A 
Date of First Enrollment (India)   10/06/2022 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   non yet 
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 (Others) -  NIL

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [chhanifanai72@gmail.com].

  6. For how long will this data be available start date provided 20-10-2023 and end date provided 23-01-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a cross-sectional survey study, assessing and comparing the prevalence of prediabetes among 20-40 years of age which will be conducted at Health and Wellness Centres in a selected urban and rural areas of Mizoram, India. Selection of samples and sites  shall be done using Proportional to Sample Size (PPS) and computer generated randomization. 
Data will be collected using Standardized Finnish Type 2 Diabetes Risk Assessment Form and collecting peripheral blood smear for fasting blood sugar and Post Prandial blood sugar. Also, a structured demographic characteristics  will be employed. 
Comparison of findings between selected urban and rural samples with regards to the prevalence of prediabetes. Also, findings will be evaluated a selected demographic characteristics.
 
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