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CTRI Number  CTRI/2017/10/010179 [Registered on: 24/10/2017] Trial Registered Prospectively
Last Modified On: 24/10/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on the prevalence of depression among diabetic patients. 
Scientific Title of Study   A study on the prevalence of depression among patients of type 2 diabetes mellitus. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Parinitha Maben 
Designation  Student 
Affiliation  Kasturba Medical College, Manipal 
Address  Parinitha Maben Flat No. 406 Wood Winds Apartments D.C. Office Road Manipal 576104 Karnataka Phone: 9008701157 email ID: parinitha.maben@yahoo.co.in

Udupi
KARNATAKA
576104
India 
Phone  9008701157  
Fax    
Email  parinitha.maben@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Parinitha Maben 
Designation  Student 
Affiliation  Kasturba Medical College, Manipal 
Address  Parinitha Maben Flat No. 406 Wood Winds Apartments D.C. Office Road Manipal 576104 Karnataka Phone: 9008701157 email ID: parinitha.maben@yahoo.co.in

Udupi
KARNATAKA
576104
India 
Phone  9008701157  
Fax    
Email  parinitha.maben@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Parinitha Maben 
Designation  Student 
Affiliation  Kasturba Medical College, Manipal 
Address  Parinitha Maben Flat No. 406 Wood Winds Apartments D.C. Office Road Manipal 576104 Karnataka Phone: 9008701157 email ID: parinitha.maben@yahoo.co.in

Udupi
KARNATAKA
576104
India 
Phone  9008701157  
Fax    
Email  parinitha.maben@yahoo.co.in  
 
Source of Monetary or Material Support  
Kasturba Medical College and Hospital, Manipal 
 
Primary Sponsor  
Name  Kasturba Medical College and Hospital Manipal 
Address  Kasturba Medical College and Hospital Madhav Nagar Near Tiger Circle Manipal 576104 Karnataka  
Type of Sponsor  Private medical college 
 
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 
Parinitha Maben  Kasturba Hospital Manipal  Medicine ward Department of Medicine Kasturba Hospital Manipal-576104
Udupi
KARNATAKA 		 9008701157

parinitha.maben@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, Kasturba Hospital, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  A study on the prevalence of depression among patients of type 2 diabetes mellitus.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  •The study group includes patients with type 2 diabetes mellitus.
•Both male and female patients and patients above 18 years of age who have been diagnosed with type 2 diabetes mellitus will be included in the study.
 
 
ExclusionCriteria 
Details  •Severely ill patients will be excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study aims at determining the prevalence of depression in patients who have been diagnosed with type 2 diabetes mellitus.  Cross sectional - one time assessment 
 
Secondary Outcome  
Outcome  TimePoints 
To associate the findings, if any, with glycaemic control, lipid profile, haemoglobin levels and other relevant biochemical parameters of the patients.  Cross sectional - one time assessment 
 
Target Sample Size   Total Sample Size="155"
Sample Size from India="155" 
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)   30/10/2017 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

   Title of the project: A study on the prevalence of depression among patients of type 2 diabetes mellitus

  • This study aims at determining the prevalence of depression in patients who have been diagnosed with type 2 diabetes mellitus.
  • To associate the above findings, if any, with glycaemic control, lipid profile, haemoglobin levels and other relevant biochemical parameters of the patients.
  • Assessment of depression will be done using the Patient Health Questionnaire (PHQ-9), a nine-item depression module which is well validated and widely used.1 “The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as “0” (not at all) to “3” (nearly every day).” 2

  • “The PHQ family of measures, including abbreviated and alternative versions as well as the GAD-7, were developed by Drs. Robert L. Spitzer, Janet B.W. Williams, Kurt Kroenke and colleagues, with an educational grant from Pfizer Inc. All of the measures (including the PHQ 9) are in the public domain. No permission is required to reproduce, translate, display or distribute.” 3

Review of Literature:

According to the 2015 Global Health Estimates, 322 million people were living with depression in 2015 which represents over 4% of the global population. In the WHO South-East Asia Region 86 million people suffer from depression. 4

Depression is the third-leading cause of disability in terms of disability-adjusted life-years. Depression in patients with chronic diseases such as cancer, diabetes mellitus, stroke or cardiovascular disease is 2–4 fold more prevalent than in people without such diseases. Moreover, chronic diseases like diabetes mellitus, hypertension, etc. have been considered as risk factors for the development of depression, suggesting a bidirectional relationship.5

Globally, the number of people living with diabetes has risen from 108 million in 1980 to 422 million in 2014. 6 According to the WHO country and regional data, the prevalence of diabetes in India was 31,705,000 in the year 2000 and is estimated to be 79,441,000 by the year 2030. 7

The rising significance of depression and chronic diseases such as diabetes being comorbid, coupled with limited resources, makes it a major public health challenge for low- and middle-income countries.5

A number of studies conducted across India have also suggested a significant relationship between diabetes mellitus and depression.

A study conducted in various tertiary care hospitals in Mangalore, Karnataka, with regard to the proportion of depression among Type 2 Diabetes Mellitus patients, found a 45.2% prevalence of depression among the participants with a higher prevalence of depression among certain patient groups such as women, elderly patients and patients on insulin therapy. However, there was no association found between depression and glycemic control among patients.8 

A study conducted in Arizona found that HbA1c was significantly higher in individuals with diabetes who were depressed than in those who were not and a probability that the severity of depression is positively correlated with HbA1c.9

Studies have also found associations between diabetes mellitus and metabolic derangements such as abnormalities in lipid profile. Type 2 diabetes mellitus is associated with dyslipidemia which in turn is a major contributor to atherosclerosis and cardiovascular disease. 10 ,11

Anemia has also been found to be prevalent in patients with diabetes and is associated with an increased risk of complications of diabetes like retinopathy, nephropathy, etc.12

Further, studies have also suggested a relationship between depression and lipid abnormalities with a higher prevalence of depressive symptoms among subjects with lower serum cholesterol and HDL levels and higher serum triglyceride levels.13 14 A study has also suggested that depression, possibly independent of its etiology, is associated with anemia in the elderly.15

A meta-analysis by Ryan J. Anderson et al. of about 42 studies done on the prevalence of depression in diabetes mellitus has reported that “a more accurate estimate of depression prevalence than what is currently available is needed to gauge the potential impact of depression management in diabetes.” 16

Keeping in mind these significant interrelations between diabetes mellitus and depression with lipid profile abnormalities and anemia, as well as the open-ended etiological speculations on the subject, this study aims at determining the prevalence of depression in patients diagnosed with type 2 diabetes mellitus and to associate this with glycemic control, lipid profile, hemoglobin levels and other relevant biochemical parameters of the patients.

In conclusion, diabetes has been found to double the risk of depression and the latter may lead to poorer health outcomes and non-adherence to the treatment of diabetes.17 However, despite this, it has been found that depression is recognized and treated appropriately in fewer than 25% of depressed diabetic patients. Thus it is important to recognize the significance of these comorbidities, to study factors that may be contributory to their coexistence and to provide appropriate intervention when necessary with an aim to improve glycemic control and quality of life of patients and to prevent the complications of diabetes.18

 

References :

1Bernd Löwe, Kurt Kroenke, et al. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). Journal of Affective Disorders Volume 81, Issue 1, July 2004.

2 Kroenke, K., Spitzer, R. L. and Williams, J. B. W. (2001), The PHQ-9. Journal of General Internal Medicine, 16: 606–613. doi:10.1046/j.1525-1497.2001.016009606.x

3https://phqscreeners.pfizer.edrupalgardens.com/sites/g/files/g10016261/f/201412/instructions.pdf

4WHO Depression Fact Sheet updated February 2017  (http://www.searo.who.int/entity/world_health_day/2017/depression-factsheet.pdf?ua=1)

5 Depression and physical noncommunicable diseases: the need for an integrated approach 12 Nazneen Anwar, Pooja Patnaik Kuppili, Yatan Pal Singh Balhara . WHO South-East Asia Journal of Public Health April, Volume 6, Issue 1 I SSN 2224-3151E-ISSN 2304-5272

6 Projections of global mortality and burden of disease from 2002 to 2030. Mathers CD, Loncar D. PLoS Med, 2006, 3(11):e442.

7WHO Diabetes Programme – Country and regional data on Diabetes in the WHO South East-Asia region (http://www.who.int/diabetes/facts/world_figures/en/index5.html)

8 Joseph N, Unnikrishnan B, Raghavendra Babu YP, Kotian MS, Nelliyanil M. Proportion of depression and its determinants among type 2 diabetes mellitus patients in various tertiary care hospitals in Mangalore city of South India. Indian Journal of Endocrinology and Metabolism. 2013;17(4):681-688. doi:10.4103/2230-8210.113761.

9 Sahota PKC, Knowler WC, Looker HC. Depression, Diabetes, and Glycemic Control in an American Indian Community. The Journal of clinical psychiatry. 2008;69(5):800-809.

10 Markku Laakso. Department of Medicine. University of Kuopio. Kuopio. Finland. Lipid disorders in type 2 diabetes.

11Lipid Disorders in Diabetes. Ronald B Goldberg. Diabetes Care Sep 1981, 4(5)561-572; DOI: 10.2337/diacare.4.5.561

12 Padmaja Kumari Rani,Rajiv Raman, et al. Anemia and Diabetic Retinopathy in Type 2 Diabetes Mellitus (JAPI-FEBRUARY 2010 VOL. 58)

13 Nikolaos Dimopoulos, MD et al. Characterization of the Lipid Profile in Dementia and Depression in   the Elderly. Journal of Geriatric Psychiatry and Neurology Vol 20, Issue 3.

14 Horsten et al. Depressive Symptoms, Social Support, and Lipid Profile in Healthy Middle-Aged Women. Psychosomatic Medicine: September/October 1997 Volume 59, Issue 5.

15 Graziano Onder et al. Anemia Is Associated With Depression in Older Adults: Results From the InCHIANTI Study. The Journals of Gerontology: Series A, Volume 60, Issue 9. (https://doi.org/10.1093/gerona/60.9.1168)

16 The Prevalence of Comorbid Depression in Adults With Diabetes. Ryan J. Anderson, Kenneth E. Freedland, Ray E. Clouse, Patrick J. Lustman. Diabetes Care Jun 2001, 24 (6) 1069-1078; DOI: 10.2337/diacare.24.6.1069

17 Sarah M.Markowitz et al. A Review of Treating Depression in Diabetes: Emerging Findings. Psychosomatics Volume 52, Issue 1, January–February 2011.

18 Richard R. Rubin, Paul Ciechanowski, Leonard E. Egede, Elizabeth H. B. Lin, Patrick J. Lustman. Recognizing and treating depression in patients with diabetes. Current Diabetes Reports April 2004, Volume 4, Issue 2.

 
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