| CTRI Number |
CTRI/2019/06/019629 [Registered on: 11/06/2019] Trial Registered Prospectively |
| Last Modified On: |
10/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess if neutrophil-lymphocyte ratio and platelet-lymphocyte ratio can be used to predict chronic kidney disease in patients with type 2 diabetes. |
|
Scientific Title of Study
|
Neutrophil-lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR) as predictive markers for chronic kidney disease in persons with type 2 diabetes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vignesh Kumar |
| Designation |
DNB Postgraduate in General Medicine |
| Affiliation |
Dr. TMA Pai Hospital |
| Address |
Department of Medicine,
Dr. TMA Pai Hospital,
Opposite Taluk Office, Court Road, Brahmagiri, Udupi, Karnataka.
Udupi
KARNATAKA
576101
India |
| Phone |
9884779293 |
| Fax |
|
| Email |
vigneshkumar.r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shashikiran Umakanth |
| Designation |
Professor and Head, Department of Medicine |
| Affiliation |
Dr. TMA Pai Hospital |
| Address |
Department of Medicine,
Dr. TMA Pai Hospital,
Opposite Taluk Office, Court Road, Brahmagiri, Udupi, Karnataka.
Udupi
KARNATAKA
576101
India |
| Phone |
9008418171 |
| Fax |
|
| Email |
shashikiran.u@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Vignesh Kumar |
| Designation |
DNB Postgraduate in General Medicine |
| Affiliation |
Dr. TMA Pai Hospital |
| Address |
Department of Medicine,
Dr. TMA Pai Hospital,
Opposite Taluk Office, Court Road, Brahmagiri, Udupi, Karnataka.
KARNATAKA
576101
India |
| Phone |
9884779293 |
| Fax |
|
| Email |
vigneshkumar.r@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. TMA Pai Hospital, Court Rd, Opposite to Taluk Office, Brahmagiri, Udupi, Karnataka 576101 |
| Kasturba Hospital, Manipal,
Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Vignesh Kumar |
| Address |
Department of Medicine,
Dr. TMA Pai Hospital,
Court Rd, Opp Taluk Office, Brahmagiri, Udupi, Karnataka 576101 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vignesh Kumar |
Dr. TMA Pai Hospital |
Department of Medicine,
Dr. TMA Pai Hospital,
Court Rd, Opposite to Taluk Office, Brahmagiri, Udupi, Karnataka 576101
Udupi
KARNATAKA |
9884779293
vigneshkumar.r@gmail.com |
| Dr Vignesh Kumar |
Kasturba Hospital, Manipal |
Department of Nephrology,
Kasturba Hospital, Manipal,
Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104.
Udupi
KARNATAKA |
9884779293
vigneshkumar.r@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Persons with type 2 diabetes without nephropathy or other complications
2. Persons with type 2 diabetes with CKD
|
|
| ExclusionCriteria |
| Details |
1. Patients having low glomerular filtration rate (GFR) without microalbuminuria will be excluded from the study.
2. Patients with type 1 DM
3. Febrile patients/patients with infections including urinary tract infection (UTI), respiratory tract infections, gastrointestinal infection, otitis media, viral hepatitis, parasitic infection, viral infection, tuberculosis, local infection, skin infection, AIDS, pyrexia of unknown origin, and any other infectious disease.
4. Patients with systemic disorder such as cardiovascular disease, chronic liver disease, blood disorders, autoimmune disorders, malignancy, poisoning;
5. Patients on anti-inflammatory drugs, systemic or topical steroids, alcohol;
6. Patients with uncontrolled blood pressure (BP);
7. Patients having diseases affecting urinary protein excretion as nephritic syndrome, urolithiasis, renal insufficiency, renal artery stenosis, dehydration state, and UTI
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
The association of Neutrophil Lymphocyte Ratio and Renal function will be studied.
Predictive value of Neutrophil Lymphocyte ratio for Chronic Kidney disease in diabetics will be assessed and compared to that of Platelet Lymphocyte ratio, High Sensitive C Reactive Protein, and Urine Microalbuminuria |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="317"
Sample Size from India="317"
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)
|
20/06/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Title: Observational cross sectional study to assess neutrophil-lymphocyte ratio and platelet lymphocyte ratio as predictive markers for chronic kidney disease in persons with type 2 diabetesThis study is a observational cross sectional study to assess neutrophil-lymphocyte ratio and platelet lymphocyte ratio as predictive markers for chronic kidney disease in persons with type 2 diabetes.
This study will be done from March 2019 to September 2020 among patients visiting Dr. TMA Pai Hospital, Udupi and Kasturba Hospital, Manipal. One group of patients will include 144 persons with type 2 diabetes mellitus who have no nephropathy or other complications. The other group will include 173 persons with type 2 diabetes mellitus with diabetic nephropathy associated kidney disease with no other apparent cause for renal failure.
Routine blood investigations such as complete blood counts, liver function tests (LFTs), renal function tests, serum electrolytes, urine routine microscopy, lipid profile, fasting blood sugar (FBS)/postprandial blood sugar (PPBS), glycated hemoglobin (HbA1c), urine microalbumin will be done and compared with similar data in the same patients more than six months old within the last year. Urine microalbumin should ideally be done on two separate occasions evaluvate the proteinuria status in a patient but for the purpose of this study only one sample will collected afresh and if available date within last 12 months will be taken into account. In addition, Highly sensitive C Reactive Protein(HSCRP) will be done on day of visit.
The association of neutrophil lymphocyte ratio and renal function will be studied. Predictive value of neutrophil lymphocyte ratio for chronic kidney disease in diabetics will be assessed and compared to that of platelet lymphocyte ratio, HSCRP, and urine microalbuminuria. |