| CTRI Number |
CTRI/2025/01/079387 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
new index for assessment of Insulin Resistance in Metabolic syndrome patients |
|
Scientific Title of Study
|
A Validation of SINGLE POINT INSULIN SENSITIVITY ESTIMATOR(SPISE) with HOMA-IR in Metabolic syndrome- A study in south Indian population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sreekumar P S |
| Designation |
Senior resident |
| Affiliation |
Madurai medical college |
| Address |
Department of Endocrinology, Madurai medical college, Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
7904026135 |
| Fax |
|
| Email |
sreekumarentr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
E Subbiah |
| Designation |
Professor of Diabetology and Endocrinology |
| Affiliation |
Madurai Medical college |
| Address |
Department of Diabetology,
Madurai Medical college and Government Rajaji Hospital, Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
9842172001 |
| Fax |
|
| Email |
subbiahegappan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sreekumar P S |
| Designation |
Senior resident |
| Affiliation |
Madurai medical college |
| Address |
Department of Endocrinology, Madurai medical college, Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
7904026135 |
| Fax |
|
| Email |
sreekumarentr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Endocrinology and diabetology, Madurai medical college, Government rajaji hospital, Madurai, India- 625020 |
|
|
Primary Sponsor
|
| Name |
Department of Endocrinology |
| Address |
MADURAI MEDICAL COLLEGE, MADURAI,TAMILNADU,INDIA-625020 |
| Type of Sponsor |
Government 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 Sreekumar P S |
Government Rajaji Hospital |
Department of Endocrinology, Madurai Medical College
Madurai
TAMIL NADU |
7904026135
sreekumarentr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Madurai medical college& Govt rajaji hospital, Madurai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Metabolic syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SPISE index |
Single Point Insulin Sensitivity Estimator |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
cases who are diagnosed as metabolic syndrome according to south asian modified -NCEP criteria |
|
| ExclusionCriteria |
| Details |
cushings syndrome, hypothyroidism, secondary hypertension, type 1 diabetes mellitus, hepatobiliary disease, nephritic syndrome, pregnancy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of SPISE and comparison with HOMA-IR |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to define a cut off for SPISE in South Indian population |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
30/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
To study the validation of single point insulin sensitivity estimator (SPISE) in metabolic syndrome patients and comparison with HOMA-IR for south indian population. for each subject demographic parameters, BP,height, weight, waist circumference, hip circumference, neck circumference, mid arm circumference, thigh circumference, mid calf circumference were measured . 4 ml venous blood sample was collected for measuring Insulin, lipid profile, fasting blood sugars. |