| CTRI Number |
CTRI/2025/09/093986 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Measuring Harmful Chemicals in the Blood of People with Type 2 Diabetes: Comparing Non-Obese and Obese Patients |
|
Scientific Title of Study
|
Evaluation of Serum Persistant Organic Pollutants (POPs) levels in Non - Obese and Obese Type 2 Diabetes Mellitus patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gowsikan K |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room no: 205, Second floor, Department of Biochemistry, Pathology block, Maulana Azad Medical College.
Central
DELHI
110002
India |
| Phone |
8825819684 |
| Fax |
|
| Email |
gowsikarthi8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arpita Suri |
| Designation |
Assistant Professor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room no: 205, Second floor, Department of Biochemistry, Pathology block, Maulana Azad Medical College.
Central
DELHI
110002
India |
| Phone |
9999718289 |
| Fax |
|
| Email |
arpita.lhmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gowsikan K |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room no: 205, Second floor, Department of Biochemistry, Pathology block, Maulana Azad Medical College.
Central
DELHI
110002
India |
| Phone |
8825819684 |
| Fax |
|
| Email |
gowsikarthi8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi, India - 110002 |
|
|
Primary Sponsor
|
| Name |
Dr Gowsikan K |
| Address |
Department of Biochemistry, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi. |
| 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 |
| Dr Gowsikan K |
Maulana Azad Medical College |
Department of Medicine & Department of Biochemistry, Maulana Azad Medical College and associated Lok Nayak Hospital.
Central
DELHI |
8825819684
gowsikarthi8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Group 1 (Non - Obese T2DM): Newly diagnosed T2DM patients with BMI of less than 25 kg/m2.
2. Group 2 (Obese T2DM): Newly diagnosed T2DM patients with BMI of more than or equal to 25 kg/m2. |
|
| ExclusionCriteria |
| Details |
1. History of chronic disorders such as renal & hepatic insufficiency and cancer.
2. Intake of metformin and topiramate or bariatric surgery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in mean/median serum POPs levels (µg/L) in non-obese and obese T2DM. |
Baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in mean/median HOMA beta and HOMA IR indices in non obese and obese T2DM. |
Baseline. |
| Association of serum POP levels with markers of beta cell dysfunction and insulin resistance in non obese and obese T2DM. |
Baseline. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
This study will be conducted in Department of Medicine and Department of Biochemistry, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi. This current study aims to evaluate the understanding of potential difference in serum POP levels between obese and non obese T2DM patients could provide valuable insights into the etiological factors contributing to the disease in these distinct phenotypes. |