| CTRI Number |
CTRI/2024/04/066567 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Metabolic Syndrome in newly detected Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Study on prevalence of Metabolic syndrome in Newly detected Type 2 Diabetes Mellitus |
| 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 Aayushi Vishvesh Vyas |
| Designation |
Resident Doctor |
| Affiliation |
D.Y.Patil School of Medicine |
| Address |
D.Y. Patil Hospital Near Ayyapa temple Sector 5 Nerul Navi Mumbai
3rd floor Department of General Medicine Near Ayyapa temple Sector 5 Nerul Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8849950163 |
| Fax |
|
| Email |
aashivyas007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Shetty |
| Designation |
Professor and Head |
| Affiliation |
D.Y.Patil School of Medicine |
| Address |
D.Y.Patil Hospital Nr. Ayyapa temple Sector 5 Nerul Navi Mumbai
Third floor Department of General Medicine
Near Ayyapa temple Sector 5 Nerul Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9833991811 |
| Fax |
|
| Email |
shettyvarun81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aayushi Vishvesh Vyas |
| Designation |
Resident Doctor |
| Affiliation |
D.Y.Patil School of Medicine |
| Address |
D.Y.Patil Hospital Nr. Ayyapa temple Sector 5 Nerul Navi Mumbai
Third floor Department of General Medicine
Near Ayyapa temple Sector 5 Nerul Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8849950163 |
| Fax |
|
| Email |
aashivyas007@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.Y.Patil Hospital and school of medicine Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
D Y PATIL HOSPITAL AND SCHOOL OF MEDICINE |
| Address |
DY Patil Hospital Near Ayyapa temple Sector 5 Nerul Navi Mumbai |
| 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 Aayushi Vyas |
D Y Patil Hospital |
Third floor Department of General Medicine
Near Ayyapa Temple Sector 5 Nerul Navi Mumbai
Thane
MAHARASHTRA |
8849950163
aashivyas007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| D Y PATIL INSTITUITIONAL ETHICS COMMITTEE FOR BIOMEDICAL HEALTH AND RESEARCH |
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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients giving consent for the study
2. Patients with newly detected type 2 diabetes mellitus
3.Outpatients attending clinics and patients admitted in the hospital |
|
| ExclusionCriteria |
| Details |
1.Pregnancy at diagnosis or gestational diabetes mellitus
2.Secondary diabetes mellitus and other types of diabetes
3.Presence of acute disease that could interfere with glucose metabolism |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Metabolic Syndrome in patients with newly detected Type 2 Diabetes Mellitus |
6 months - 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dyslipidemia & cardiovascular complications in patients with Type 2 Diabetes Mellitus |
6 months to 1 year |
|
|
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)
|
06/05/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aashivyas007@gmail.com].
- For how long will this data be available start date provided 01-05-2025 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The greatest majority of patients with type 2 diabetes or impaired glucose tolerance have metabolic syndrome. The presence of metabolic syndrome in these populations relates to a higher prevalence of cardiovascular disease than in patients who have type 2 diabetes or impaired glucose tolerance who do not have the syndrome. Individuals with metabolic syndrome are twice as likely to die of cardiovascular disease as those who do not, and their risk of an acute myocardial infarction or stroke is threefold higher. With appropriate cardiac rehabilitation and changes in lifestyle the prevalence of syndrome can be reduced. |