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CTRI Number  CTRI/2025/08/092588 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 22/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence of Depression in patients different stages of Diabetic Nephropathy 
Scientific Title of Study   THE PREVALENCE OF DEPRESSION AND FACTORS AFFECTING DEPRESSION IN PATIENTS WITH DIABETIC NEPHROPATHY IN A TERTIARY CARE CENTER IN SOUTH INDIA :- A CROSS SECTIONAL 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  Shivalik Verma 
Designation  Junior Resident 
Affiliation  KAHERs Jawaharlal Nehru Medical College  
Address  Department Of Psychiatry J.N.Medical College Belagavi , Karnataka Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9589299475  
Fax    
Email  shivalikverma100@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bheemsain V Tekkalaki  
Designation  Associate Professor  
Affiliation  KAHERs Jawaharlal Nehru Medical College  
Address  Department Of Psychiatry J.N.Medical College Belagavi , Karnataka Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9886674849  
Fax    
Email  tbheemsain@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shivalik Verma  
Designation  Junior Resident 
Affiliation  KAHERs Jawaharlal Nehru Medical College  
Address  Department Of Psychiatry J.N.Medical College Belagavi , Karnataka Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9589299475  
Fax    
Email  shivalikverma100@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Shivalik Verma 
Address  Department Of Psychiatry J.N.Medical College Belagavi Karnataka 590010 
Type of Sponsor  Other [Self] 
 
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 Shivalik Verma  KLE Dr Prabhakar kore Hospital   Department of Endocrinology and Nephrology
Belgaum
KARNATAKA 
9589299475

shivalikverma100@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, (2) ICD-10 Condition: E102||Type 1 diabetes mellitus with kidney complications, (3) ICD-10 Condition: E082||Diabetes mellitus due to underlying condition with kidney complications, (4) ICD-10 Condition: E092||Drug or chemical induced diabetesmellitus with kidney complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients between the years of 18 and 60 years of age
2) Patients diagnosed with Diabetic Nephropathy of any stage
3) Patients who are willing to give informed consent  
 
ExclusionCriteria 
Details  1) Patients having history of Pre-existing major psychiatric illness
2) Patients having other serious disease and other chronic medical conditions excluding hypertension
3) Patients having other diabetic complications other than diabetic retinopathy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the prevalence of depression and factors affecting it in patients with different stages of diabetic nephropathy   1st July 2025 - 30th June 2026 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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)   18/08/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  

Diabetes mellitus is a chronic metabolic disorder that has become a global health concern due to its seismic effect on individual health and substantial socioeconomic status affecting the families as well. Type 2 diabetes mellitus (T2DM) is the most common chronic metabolic disease in our country, primarily characterised by hyperglycaemia due to insulin resistance along with macrovascular and microvascular complications that affect various organ systems, including cardiovascular, renal, neurological, and ocular system. Diabetic nephropathy is a common complication in patients with T2DM, classified as a microvascular complication and the leading cause of end-stage kidney disease (ESKD). Depression is the most common psychiatric illness worldwide, and its prevalence is twice as high in patients with diabetes and is seen with  persistent low mood, anhedonia, fatigue, reduced appetite, poor concentration, and, in severe cases, suicidal ideation. Depression in diabetic patients contributes to worse glycaemic control, increased inflammation, higher oxidative stress, and poorer disease management, all of which accelerate the progression of Diabetic Nephropathy .This study aims to find out the prevalence of depression using scales such as PHQ-9 and assessing depression across various stages of diabetic nephropathy and correlating its different parameters associated with the severity of diabetic nephropathy in an indian setting. 





 
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