| CTRI Number |
CTRI/2025/07/092117 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding the Link Between Gut Health and Type 2 Diabetes Mellitus in adults aged 30 to 50 |
|
Scientific Title of Study
|
Exploring the Relationship Between Gut Health and Type 2 Diabetes Mellitus: An Exploratory 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 |
Dhanashree Logade |
| Designation |
Student |
| Affiliation |
Dr. B.M.N. College of Home Science |
| Address |
Dr BMN College of Home Science Divya Rishi Apartment 338 R A Kidwai Marg Matunga East Mumbai Maharashtra 400019 India
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9004458901 |
| Fax |
NIL |
| Email |
dhanashreelogade152@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinaya Vaishampayan |
| Designation |
Vice Principal and Head Department of Food Science and Nutrition |
| Affiliation |
Dr. B.M.N.College of Home Science |
| Address |
Dr. B.M.N.College of Home Science Divya Rishi Apartment 338 R.A. Kidwai Marg Matunga East Mumbai Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9967586292 |
| Fax |
|
| Email |
vinaya@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinaya Vaishampayan |
| Designation |
Vice Principal and Head Department of Food Science and Nutrition |
| Affiliation |
Dr. B.M.N.College of Home Science |
| Address |
Dr. B.M.N.College of Home Science Divya Rishi Apartment 338 R.A. Kidwai Marg Matunga East Mumbai Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9967586292 |
| Fax |
|
| Email |
vinaya@bmncollege.com |
|
|
Source of Monetary or Material Support
|
| Dr. BMN College of Home Science Department of Clinical Nutrition and Dietetics 338 R A Kidwai Marg Matunga East Mumbai Maharashtra 400019 |
|
|
Primary Sponsor
|
| Name |
Dhanashree Logade |
| Address |
Dr BMN College of Home Science Divya Rishi Apartment 338 R A Kidwai Marg Matunga East Mumbai Maharashtra 400019 India |
| Type of Sponsor |
Other [Self] |
|
|
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 Rupali Sengupta |
Dr BMN College of Home Science |
Department of Clinical Nutrition and Dietetics Divya Rishi Apartment 338 R.A. Kidwai Marg Matunga East Mumbai Maharashtra 400019
Mumbai
MAHARASHTRA |
9892415789
rupali@bmncollege.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Educational Society Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed with T2DM for more than 6 months
2.Working individuals belonging to middle-income households (as per Kuppuswamy socioeconomic status scale - 11 to 25 score)
3.Both male and female participants
4.Willing to provide informed consent
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of relationship between gut health and Type 2 Diabetes Mellitus with a focus on assessing gut health status and identifying dietary and lifestyle factors associated with gut dysbiosis in individuals |
10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the nutritional status of individuals with type 2 diabetes mellitus using anthropometric measurements using BMI WHR & their potential influence on gut health.
|
5 weeks |
| To evaluate the dietary intake & dietary patterns of individuals with type 2 diabetes mellitus & their potential influence on gut health |
5 weeks |
| to assess the gut health & appetite status using validated international scales in type 2 diabetes individuals |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
11/08/2025 |
| 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="0"
Months="5"
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
|
this study aims to investigate the relationship between gut health and type 2 diabetes mellitus particularly focusing on how diet lifestyle and use of probiotics and prebiotics affect this relationship the study is motivated by growing evidence linking gut dysbiosis with metabolic diseases insulin resistance and poor glycemic control in diabetic individuals using a cross sectional design the study will assess 150 adults with long standing diabetes in mumbai evaluating their nutritional status dietary patterns physical activity and gut health through validated tools like GSRS and Bristol stool chart participants will be stratified by age gender and medication type. the research seeks to identify modifiable dietary and lifestyle factors with gut imbalance and assess their impact on glycemic outcomes such as HbA1c fasting and postprandial blood glucose. this study provides practical recommendations for diabetes care through gut health improvement |