| CTRI Number |
CTRI/2024/08/072382 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To measure serum prolactin levels in Obese patients with type 2 Diabetes mellitus and to infer its association with cardiovascular complications. |
|
Scientific Title of Study
|
Prolactin levels in Obese type 2 Diabetes mellitus patients and its association with Carotid intima media thickness. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun Kumar |
| Designation |
First year Junior Resident |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of General Medicine,
AIIMS Bathinda,
Mandi Dabwali road,
Punjab.
Bathinda
PUNJAB
151001
India |
| Phone |
07358743463 |
| Fax |
|
| Email |
arunhere98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Singh Dhoat |
| Designation |
Professor and Head of Department |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of General Medicine,
AIIMS Bathinda,
Mandi Dabwali road,
Punjab.
Bathinda
PUNJAB
151001
India |
| Phone |
7888849499 |
| Fax |
|
| Email |
drpreetidhoat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Singh Dhoat |
| Designation |
Professor and Head of Department |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of General Medicine,
AIIMS Bathinda,
Mandi Dabwali road,
Punjab.
Bathinda
PUNJAB
151001
India |
| Phone |
7888849499 |
| Fax |
|
| Email |
drpreetidhoat@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,
Mandi Dabwali road,
Bathinda,
Punjab - 151001,
India. |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Arun Kumar |
All India Institute of Medical Sciences, Bathinda. |
Department of General Medicine,
OPD building, Ground floor C block,
All India Institute of Medical Sciences,
Bathinda,
Punjab.
Bathinda
PUNJAB |
7358743463
arunhere98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences Bathinda, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition:E116||Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: PRAMEHA-PIDAKA, (2) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients more than 18 years of age.
2. Patients with Type 2 Diabetes mellitus and Obesity. |
|
| ExclusionCriteria |
| Details |
1. Pregnant females.
2. Patients less than 18 years of age. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the levels of Prolactin in Obese Type 2 Diabetes mellitus patients. |
Prolactin levels will be assessed during the first visit of the patient. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the association between Prolactin levels & carotid intimal medial thickness in Obese patients with Type 2 Diabetes mellitus. |
Prolactin levels & carotid intima media thickness shall be measured on the first visit. Each patient prolactin level will be correlated with their carotid intima & medial thickness on the first visit itself. No follow up is needed further in this study. |
|
|
Target Sample Size
|
Total Sample Size="224"
Sample Size from India="224"
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)
|
23/08/2024 |
| 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="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
|
The study includes recruiting Obese patients with Type 2 Diabetes mellitus presenting to OPD and IPD of Internal medicine department, and those meeting the inclusion criteria will be enrolled in the study. Detailed history will be taken and Anthropometry will be done. Once the patient fits the inclusion criteria, they will be explained about the study and written informed consent will be taken. USG Carotid doppler will be taken to measure Carotid intima media thickness. Serum Prolactin levels will be measured. The results will be compared with healthy volunteers who are non-obese and non-diabetic. And thus the association between Serum Prolactin levels and Carotid intimal and medial thickness with Obese Type 2 Diabetes mellitus will be determined.
|