| CTRI Number |
CTRI/2025/03/081507 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Tuberculosis in Patients of Diabetes Mellitus |
|
Scientific Title of Study
|
Clinico-Investigative Profile of Type 2- Diabetes Mellitus in Tuberculosis At A Tertiary Care Centre: An Observational 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 |
Steve Thomas |
| Designation |
Junior Resident |
| Affiliation |
Dr DY Patil Medical College,Navi Mumbai |
| Address |
Department of General Medicine Dr DY Patil Medical College, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9967935552 |
| Fax |
|
| Email |
stevethomas799@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Patil |
| Designation |
Professor |
| Affiliation |
Dr DY Patil Medical College,Navi Mumbai |
| Address |
Department of General Medicine Dr DY Patil Medical College, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9821027742 |
| Fax |
|
| Email |
smita.patil@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Steve Thomas |
| Designation |
Junior Resident |
| Affiliation |
Dr DY Patil Medical College,Navi Mumbai |
| Address |
Department of General Medicine Dr DY Patil Medical College, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9967935552 |
| Fax |
|
| Email |
stevethomas799@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr DY Patil Medical College and Hospital, Navi Mumbai, Maharashtra 400706
India |
|
|
Primary Sponsor
|
| Name |
Dr DY Patil Medical College and Hospital |
| Address |
Dr DY Patil Hospital, Sector 5, Ayyapa Road,Nerul , Navi Mumbai 400706 |
| Type of Sponsor |
Private medical college |
|
|
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 Steve Thomas |
Dr DY Patil Hospital |
OPD No.1(General Medicine),OPD No.76(Pulmonary medicine), Female Medical ward,Male Medical ward ,Female Pulmonary Ward,Male Pulmonary Ward, Intensive care unit,
Dr DY Patil Hospital, Nerul, Navi Mumbai 400706
Thane
MAHARASHTRA |
9967935552
stevethomas799@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research,Dr DY Patil Medical College,Navi Mumbai |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving consent for the study
Patients of both the genders and above the age of 18 years
Symptoms of both Type 2 Diabetes Mellitus and Pulmonary/Extra Pulmonary Tuberculosis.
|
|
| ExclusionCriteria |
| Details |
Known case of Type 1 Diabetes Mellitus
Pregnant women
Known case of malignancy
Known case of psychiatric disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the clinico- investigative profile of Type 2 Diabetes Mellitus in Pulmonary and Extra pulmonary tuberculosis at a tertiary care centre.
|
Baseline 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the correlation of Clinical profile and Investigations in patient presenting with Type 2 Diabetes Mellitus in Pulmonary and Extra Pulmonary Tuberculosis.
To Counsel patients for better glycemic control in Type 2 Diabetes Mellitus with Pulmonary and Extra Pulmonary Tuberculosis. |
Baseline 1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
12/03/2025 |
| 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
|
Diabetes mellitus as defined by the World Health Organization (WHO) is a metabolic disorder of multiple etiology characterized by chronic hyperglycemia with disturbances in carbohydrate, protein, and fat metabolism as a result of relative or absolute lack of insulin resulting in long-term damage to various organs/systems.1 The consequences of DM alone can be quite devastating with organ failures, acute and chronic complications, and compromised quality of life. Tuberculosis is a chronic infection (caused by Mycobacterium tuberculosis) that can affect several organs in the human body, but with a much higher predilection for the lungs. Tuberculosis is defined as infection by Mycobacterium tuberculosis.2 Diabetes mellitus in combination with TB, can result in significant physical, social, psychological, and economic imbalance. Infections complicating diabetes mellitus (DM) are frequent occurrences in the setting of suboptimal diabetes control which appears to be quite common in developing countries of Asia and Africa.3,4 The contribution of tuberculosis (TB) to the diabetes epidemic has recently made a comeback to the front burner of the problems of diabetes and infections. To further compound issues, timely recognition of TB in the setting of DM, doctor/physician inertia to appropriately evaluate the DM patient for TB, and knowledge gaps in the treatment of these two chronic health problems continue to impoverish the already overstretched lean health resources of most developing economies. Glycemic control helps reduce the morbidity and mortality and have better clinical and social outcomes in patients of DM with TB |