| 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
|
|
|
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
|
|
|
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
|
|
|
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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