| CTRI Number |
CTRI/2023/11/059973 [Registered on: 17/11/2023] Trial Registered Prospectively |
| Last Modified On: |
09/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study Of Raised Blood Sugars, Blood Pressure, Triglycerides, HDL Cholesterol And Central Obesity In Different Weight Categories.
|
|
Scientific Title of Study
|
STUDY OF METABOLIC SYNDROME AND ITS INDIVIDUAL FEATURES ACROSS DIFFERENT BODY MASS INDEX(BMI) CATEGORIES. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lokesh Pangavhane |
| Designation |
Junior Resident |
| Affiliation |
DY Patil School Of Medicine and Hospital |
| Address |
Department of General Medicine, DY Patil School of Medicine and
Hospital
Nerul
Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8329398244 |
| Fax |
|
| Email |
lokeshpangavhane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nivedita Moulick |
| Designation |
Professor |
| Affiliation |
DY Patil School Of Medicine and Hospital |
| Address |
Department of General Medicine, DY Patil School of Medicine and
Hospital,
Nerul,
Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9833022282 |
| Fax |
|
| Email |
ndmoulick@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lokesh Pangavhane |
| Designation |
Junior Resident |
| Affiliation |
DY Patil School Of Medicine and Hospital |
| Address |
Department of General Medicine, DY Patil School of Medicine and
Hospital
Nerul
Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8329398244 |
| Fax |
|
| Email |
lokeshpangavhane@gmail.com |
|
|
Source of Monetary or Material Support
|
| DY Patil School of Medicine and
Hospital |
|
|
Primary Sponsor
|
| Name |
DY Patil School Of Medicine and Hospital |
| Address |
DY Patil School Of Medicine and Hospital, Nerul, Navi Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| LOKESH PANGAVHANE |
DY Patil School Of Medicine and Hospital |
Department of General Medicine
Nerul
Navi Mumbai
Thane
MAHARASHTRA |
8329398244
lokeshpangavhane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health research of Dr D Y Patil Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
DIABETES MELLITUS.
HYPERTENSION.
HYPERLIPIDEMIA.
CENTRAL OBESITY. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
outpatients attending clinics and patients admitted in hospital. |
|
| ExclusionCriteria |
| Details |
Patients not giving consent.
Bed ridden patients.
Acutely ill patients.
Hemodynamically ill patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percent of participants with metabolic syndrome fitting in different BMI categories. |
1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| percent of participants with individual features of metabolic syndrome fitting in different BMI categories. |
1 year. |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
20/11/2023 |
| 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
|
Metabolic syndrome consists of constellation of metabolic abnormalities that confer increased risk cardiovascular diseases and diabetes mellitus .Major features of metabolic syndrome include central obesity, hypertriglyceridemia, low levels of high density lipoprotein cholesterol, hyperglycemia and hypertension. AIMS- Study of metabolic syndrome and its individual features across different BMI categories in a tertiary Centre. OBJECTIVES- 1. To diagnose cases of metabolic syndrome clinically and biochemically. 2. To find cases with individual features of metabolic syndrome. 3. To calculate BMI of those cases and categorize them. |