| CTRI Number |
CTRI/2025/09/094126 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Prediabetes in Overweight People Living in Kanpur City |
|
Scientific Title of Study
|
Prediabetes among Overweight Individuals residing in an Urban Area of Kanpur: A Cross-Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yashika Bhardwaj |
| Designation |
PhD Scholar (Medical Laboratory Technology) |
| Affiliation |
School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh, India |
| Address |
Room No: SHS 133, Department of Microbiology, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
8445181791 |
| Fax |
|
| Email |
yashikabhardwaj62@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MUNISH RASTOGI |
| Designation |
Associate Professor |
| Affiliation |
School of Health Sciences, Chhatrapati Shahu Ji Maharaj University |
| Address |
Room No: SHS 135, Department of Microbiology. School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
9450164012 |
| Fax |
|
| Email |
munishkanuni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yashika Bhardwaj |
| Designation |
PhD Scholar (Medical Laboratory Technology) |
| Affiliation |
School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh, India |
| Address |
Room No: SHS 133, Department of Microbiology, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
8445181791 |
| Fax |
|
| Email |
yashikabhardwaj62@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Health Sciences, CSJM University, Kalyanpur, Kanpur, 208024, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
NO |
| Address |
NIL |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Yashika Bhardwaj |
Chhatrapati Shahu Ji Maharaj University |
Room No: SHS 133, Department of Microbiology
Kanpur Nagar
UTTAR PRADESH |
8445181791
yashikabhardwaj62@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethical Committee, Chhatrapati Shahu Ji Maharaj University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals who are overweight, as indicated by a higher BMI, face an increased risk of developing prediabetes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Male & female subjects age between 18-40 years.
2. Have no known metabolic or endocrine disorders.
3. Be willing to complete questionnaires.
|
|
| ExclusionCriteria |
| Details |
1. Are critically ill or pregnant.
2. Have undergone significant lifestyle changes in the last six months (e.g., major weight loss/gain, started a new exercise program).
3. Have a history of substance abuse within the last year (e.g., drugs or alcohol).
4. Have any physical disability that limits mobility or prevents participation in the anthropometric assessments.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The proportion of prediabetes among overweight urban adults in Kanpur was assessed at baseline using fasting and laboratory analysis, and is expressed as the percentage of participants who met the prediabetes diagnostic criteria at the time of screening.
|
All outcomes will be measured at baseline (initial screening and sample collection). Predictive model outcomes will be generated after data analysis is completed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
15/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This cross-sectional study aims to estimate the prevalence of prediabetes among overweight young adults residing in urban Kanpur. It will investigate the impact of lifestyle habits such as diet, physical activity, sleep quality, and stress on hormonal and biochemical markers associated with prediabetes. Data will be collected through questionnaires, anthropometric measurements, and blood samples. Advanced artificial intelligence techniques will be used to analyze the data, identify key determinants, and develop a predictive model for prediabetes risk. The study seeks to provide insights to support early interventions and preventive strategies tailored for young adults at risk of developing type 2 diabetes. |