| 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
|
|
|
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
|
|
|
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. |