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CTRI Number  CTRI/2024/12/078506 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 20/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Study the changes in anti-inflammatory and anti-oxidative biomarkers in Type 2 diabetes patients on treatment with different drugs 
Scientific Title of Study   Study the changes in anti-inflammatory and anti-oxidative biomarkers in Type 2 diabetes patients on Metformin treatment with combination drugs of Metformin+Vildagliptin and Metformin+Glimipride  
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 Savita Devi 
Designation  Research Scientist-I 
Affiliation  KALPANA CHAWLA GOVT. MEDICAL COLLEGE KARNAL 
Address  Room No 426, 4th Floor, Multidisciplinary Research Unit, Kalpana Chawla Govt. Medical College Karnal

Karnal
HARYANA
132001
India 
Phone  9518189146  
Fax    
Email  savitajohn4@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Savita Devi 
Designation  Research Scientist-I 
Affiliation  KALPANA CHAWLA GOVT. MEDICAL COLLEGE 
Address  Room No 426, Multidisciplinary Research Unit, Kalpana Chawla Govt. Medical College, KARNAL

Karnal
HARYANA
132001
India 
Phone  9518189146  
Fax    
Email  savitajohn4@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Savita Devi 
Designation  Research Scientist-I 
Affiliation  KALPANA CHAWLA GOVT. MEDICAL COLLEGE 
Address  Room No. 426, 4th floor, Multidisciplinary Research Unit, Kalpana Chawla Govt. Medical College, KARNAL


HARYANA
132001
India 
Phone  9518189146  
Fax    
Email  savitajohn4@gmail.com  
 
Source of Monetary or Material Support  
Multidisciplinary Reseach Unit, Kalpana Chawla Govt. Medical College-Department of Health Research, New Delhi, Pin Code:110001 
 
Primary Sponsor  
Name  Department Of Health Research  
Address  New Delhi, India, Pin Code:110001 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Savita Devi  Multidisciplinary Research Unit, Kalpana Chawla Govt. Medical College, Karnal  Room No. 426, 4th floor, Multidisciplinary Research Unit, Kalpana Chawla Govt. Medical College, Karnal
Karnal
HARYANA 
9518189146

savitajohn4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE KCGMC, KARNAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z13||Persons encountering health services for examinations,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Metformin  Anti-inflammatory and anti-oxidative biomarkers level on treatment with metformin 500mg or 1 gm for one month oral treatment daily OD or BD depending on disease severity  
Intervention  Metformin+Glimipride   anti-inflammatory and anti-oxidative biomarkers level on treatment with metformin (500mg or 1 gm)+ Glimipride 4mg or depending on disease severity for one month oral treatment daily OD or BD depending on disease severity  
Intervention  Metformin+Vildagliptin   anti-inflammatory and anti-oxidative biomarkers level on treatment with metformin (500mg or 1 gm)+ Vildagliptin 50mg for one month oral treatment daily OD or BD depending on disease severity  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of 18-60 yrs age group
Patients willing to provide written informed consent
Patients diagnosed withT2DM
Patients will be recruited as per ICMR guidelines for management of T2DM, 2018
 
 
ExclusionCriteria 
Details  1. Patients with chronic disease, smoking, or alcohol addiction during the last 3 months
2. Patients who are not willing to provide written informed consent
3. Pregnant and lactating women
4. Patients with history of allergy
5. Patients with endocrine diseases other than T2DM (e.g. hypothyroidism or hyperthyroidism, hypertension
6. Patients with the presence of malignancies, chronic liver disease renal failure, OCD, chronic inflammatory disorders and acute infections
7. Patients with hypersensitivity to treatment medications, receiving herbal and hormonal therapies
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This is the first study which will emphasis over the biomarkers status at antioxidative and antiinflammatory level which is required in the present time to develop a safe therapy for T2DM patients  at baseline and after one month of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
a safe therapy along with no or little side-effects for the better quality of life of T2DM patients & reduce the mortality rate for T2DM patients.   at baseline & after one month of treatment 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   01/01/2025 
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="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 - NO
Brief Summary  

The present study involves three groups: 1) Metformin 2) Metformin along with Vildagliptin 3) Metformin along with glimipiride. The drug treatment will be prescribed depending on the condition of patients by the physician as in case of initiation of treatment, it is usual practice to prescribe metformin, however, if it fails to achieve the hypoglycemic control in around 3 months, then combination therapy of Metformin+Vildagliptin and Metformin+glimipride (patients with GI complications) will be prescribed for the patients. In the present study, at baseline level 75 patients will be divided in to three groups of 25 patients each who are confirmed with T2DM by fasting blood sugar and glycated hemoglobin (HbA1c). Other than this, cholesterol, triglyceride, HDL, LDL amd VLDL will be analysed. In the patients, this will be followed by estimation of status of anti-oxidative biomarkers, superoxide dismutase in plasma. Followed by this, the level of anti-inflammatory biomarkers will be assessed including CRP, Nuclear factor-kappa B (NF-kB), AGE, RAGE and interleukin-6 (IL-6) in T2DM patients’ plasma. The sample will be collected from the patients who will visit the outpatient department of the hospital for taking the prescription from the physicians and sample will be collected at the same time for performing the different basic investigations and also, after one month of different treatments to see the beneficial effects of the drugs, hence, in total two time blood sample will be collected for one time follow up after one month post treatment. No charges will be taken from the patients as the fund for performing the investigations of the study is already approved by the LRAC, MRU, KCGMC, Karnal (budget details attached), rather it is beneficial for the patients to know the status of biomarkers and getting better treatment or doses regulation based on the status of biomarkers by the physician. The patients’ blood samples of five mL will be collected for the investigations required for a diabetic patient which will be utilized for the estimation of different anti-oxidative and anti-inflammatory biomarkers, therefore, no extra blood sample will be taken to minimize the harm to the patients. The number of patients visiting to the OPD of KCGMC is enough to meet the sample size in one year for the present study as observed by the PI. Thereafter, these confirmed patients will be provided treatment: A) Metformin B) Metformin + Vildagliptin C) Metformin + glimipiride. Different drug treatment will be prescribed by the clinicians and only observations will be recorded by the investigators. The tests will be performed by the staff of MRU, KCGMC, Karnal in the laboratory. The patients’ blood samples will be collected after one month of treatment for the estimation of different antioxidative biomarkers including superoxide dismutase level. Followed by this, different anti-inflammatory biomarkers will be estimated including CRP, Nuclear factor-kappa B (NF-kB), AGE, RAGE, and interleukin-6 (IL-6) in plasma. Other than this, fasting blood sugar and glycated hemoglobin (HbA1c), cholesterol, triglyceride, HDL, LDL and VLDL will be analysed.

 
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