| CTRI Number |
CTRI/2025/10/096084 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to see how the diabetes medicine Tirzepatide affects kidney health and body metabolism in people who are overweight and have Type 2 diabetes. |
|
Scientific Title of Study
|
Assessment of Renometabolic Effects of Tirzepatide in Obese Type 2 Diabetes Mellitus Patients with Shrunken Pore Syndrome |
| 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 M G Rajanandh |
| Designation |
PROFESSOR |
| Affiliation |
SRM College of Pharmacy, SRM IST |
| Address |
Room no 4, 4th floor, B block, Department of Pharmacy Practice, SRM Medical College Hospital and Research Centre,
SRM IST,
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7598464723 |
| Fax |
|
| Email |
mgr@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sabesh S |
| Designation |
Student |
| Affiliation |
SRM College of Pharmacy, SRM IST |
| Address |
Room no 5, 4th floor, B block, Department of Pharmacy Practice, SRM Medical College Hospital and Research Centre,
SRM IST,
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7338971792 |
| Fax |
|
| Email |
sabesh619@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sabesh S |
| Designation |
Student |
| Affiliation |
SRM College of Pharmacy, SRM IST |
| Address |
Room no 5, 4th floor, B block, Department of Pharmacy Practice, SRM Medical College Hospital and Research Centre,
SRM IST,
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7338971792 |
| Fax |
|
| Email |
sabesh619@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sabesh S |
| Address |
Room no 5, 4th floor, Department of Pharmacy Practice, SRM Medical College Hospital and Research Centre,
SRM IST, kattankulathur, chengalpattu 603203, Tamil Nadu, 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 MG Rajanandh |
SRM Medical College Hospital and Research Centre |
Room no 1, 4th floor, B block, SRM MCH & RC,
SRM IST,
Kattankulathur, Chengalpattu
Kancheepuram
TAMIL NADU |
7338971792
mgr@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Ability to provide written informed consent, BMI greater than or equal to 25 kg per m²,Diagnosed T2DM (HbA1c greter than 7 percentage), eGFRcr between 30 and 90 ml per min per 1.73 m² body surface area, Planned initiation of tirzepatide therapy based on clinical decision
|
|
| ExclusionCriteria |
| Details |
Type 1 diabetes mellitus, Pregnancy or lactation, Severe GI disorders or malabsorption, Acute Kidney Injury, Severe hepatic impairment, Current diagnosis of any malignancy, Subject who participated in any other clinical investigation using an experimental drug in the past 3 months, Concurrent participation in another clinical trial
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean change in eGFRcys:eGFRcr ratio,
Mean change in body weight |
Outcomes will be assessed at baseline (before starting Tirzepatide), 4 weeks, 8 weeks , and 12 weeks after starting treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of adverse events, especially gastrointestinal (GI) side effects,
Mean change in Diabetes-Specific Quality of Life Scale (DSQOLS) scores for diabetes
Mean change in Patient Reported Outcomes in Obesity (PROS) questionnaire scores
Correlation between socioeconomic status and changes in quality-of-life scores |
From baseline to Week 12 |
|
|
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)
|
31/10/2025 |
| 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="1"
Days="1" |
|
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 is a 12-week, prospective, observational pilot evaluating how tirzepatide a medication for type 2 diabetes affects kidney filtration and metabolic health in obese adults with and without shrunken pore syndrome. Sixty participants (30 with shrunken pore syndrome and 30 controls) will receive standard tirzepatide dosing and undergo assessments at baseline, weeks 4, 8, and 12. Primary outcomes include the mean change in the ratio of cystatin C–based to creatinine-based estimated glomerular filtration rate and the mean change in body weight from baseline to week 12. Secondary outcomes assess glycemic control (HbA1c), adverse drug reactions, and patient-reported quality of life using validated questionnaires. Detailed clinical, laboratory, and safety evaluations at each visit will inform the impact of tirzepatide on renal-metabolic parameters in this high risk population. |