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CTRI Number  CTRI/2017/08/009422 [Registered on: 21/08/2017] Trial Registered Retrospectively
Last Modified On: 29/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Biochemical tests]  
Study Design  Other 
Public Title of Study   Stress associated changes in Patients With Type 2 Diabetes Mellitus and Obesity 
Scientific Title of Study   Evaluation of Stress and Associated Biochemical Changes in Patients With type 2 Diabetes Mellitus and Obesity 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prem Kapoor 
Designation  Associate Professor 
Affiliation  Department of Medicine 
Address  Dept. of Medicine, HIMSR and HAH - Centenary Hospital Hamdard University
Room No. 27, OPD, Majeedia Hospital, HAH - Centenary Hospital Hamdard University
South
DELHI
110062
India 
Phone  9818158148  
Fax    
Email  kapurprem@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Kanchan Tyagi 
Designation  PhD Schloar 
Affiliation  Jamia Hamdard  
Address  Centre for Translational and Clinical Research, Jamia Hamdard, 3rd Floor, Jamia Hamdard University
Hamdard Nagar
South
DELHI
110062
India 
Phone  9810535518  
Fax    
Email  kanchan.tyagi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kanchan Tyagi 
Designation  PhD Schloar 
Affiliation  Jamia Hamdard  
Address  Jamia Hamdard University
Hamdard Nagar
South
DELHI
110062
India 
Phone  9810535518  
Fax    
Email  kanchan.tyagi@gmail.com  
 
Source of Monetary or Material Support  
Self sponsored as working professional 
 
Primary Sponsor  
Name  Jamia Hamdard UNiversity 
Address  Hamdard Nagar 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prem Kapur  HAH – Centenary Hospital  Hamdard Nagar, Delhi -110062
South
DELHI 
9818158148

kapurprem@yahoo.com 
Dr Prem Kapur  HAH Centenary Hospital  OPD room no. 27, Ground floor HAH Centanary Hospital, Hamdard Nagar, Delhi -110062
South
DELHI 
9818158148

kapurprem@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jamia Hamdard Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Blood sample for Serum cortisol and Adiponectin Levels in Diabetic patients  Serum cortisol and Adiponectin Levels 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients who have given written informed consent for study participation
2.Males and females patients aged >18 years and <65 years (both inclusive)
3.Patients having diagnosis of type 2 diabetes as defined by American Diabetes Association (ADA 2015) criteria i.e., Hb1Ac ≥6.5%
4.Patients who are controlled on anti-diabetic treatment for at-least last six months
5.Body mass index ≥30.0 kg/m2
6.Ability to understand study procedures and to comply with them

Inclusion Criteria for control group:

1.Patients who have given written informed consent for study participation
2.Males and females patients aged >18 years and <65 years (both inclusive)
3.Patients with no clinically significant illness and/or disease
4.Absence of diagnosis of type 2 diabetes
5.Absence of diagnosis of depression/anxiety or any other psychiatric disorder
6.Ability to understand study procedures and to comply with them

 
 
ExclusionCriteria 
Details  1.Patients with history or current smokers, drug or alcohol dependence
2.Any other major psychiatric illness such as schizophrenia or mental retardation.
3.Uncontrolled hypertension (blood pressure 180/105 mmHg or above)
4.Patient who are already on any psychotropic drug
5.Patient diagnosed with any psychological, behavioral disorder or severe cognitive impairment
6.Patient with any past history of a psychiatric disorder
7.Pregnant or breast feeding women
8.Inability or unwillingness to give written informed consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To identify depressive and non-depressive population among diabetic obese patients dependent on differential levels of cortisol and/or adiponectin.
2. To evaluate the effect of oral hypoglycemic drugs on the levels of adiponectin and cortisol.
 
1. To identify depressive and non-depressive population among diabetic obese patients dependent on differential levels of cortisol and/or adiponectin.
2. To evaluate the effect of oral hypoglycemic drugs on the levels of adiponectin and cortisol.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Identify stress susceptible and stress resilient population among patients using questionnaire
2. Identify depressive and non-depressive population among patients using PHQ-9
3. Change in cortisol and/or adiponectin levels with depression
4. Results of bimodal populations obtained from stress-questionnaire, depression questionnaire, cortisol/adiponectin levels
5. Evaluate the reliability of adiponectin and cortisol levels in identifying depressive phenotypes among diabetic obese patients
 
After complete enrollment 
•Identify stress susceptible and stress resilient population among patients using questionnaire
•Identify depressive and non-depressive population among patients using PHQ-9
•Change in cortisol and/or adiponectin levels with depression
•Results of bimodal populations obtained from stress-questionnaire, depression questionnaire, cortisol/adiponectin levels
•Evaluate the reliability of adiponectin and cortisol levels in identifying depressive phenotypes among diabetic obese patients  
after complete enrollment 
 
Target Sample Size   Total Sample Size="153"
Sample Size from India="153" 
Final Enrollment numbers achieved (Total)= "158"
Final Enrollment numbers achieved (India)="158" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2016 
Date of Study Completion (India) 20/12/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

It is an open-label, cross-sectional interventional tidy. The study is designed to find any biochemical changes that can be estimated in population which can differentiate them into stress resilient and stress susceptible individuals, and further into those that will develop or not develop depression.

The body coordinates the stress response by deploying multiple stress mediators viz; transmitters (e.g. norepinephrine / epinephrine/ serotonin), peptides (e.g. corticotrophin releasing factor, dynorphins), hormones (e.g. cortisol /humans and corticosterone/rodents, angiotensin). The complexity to an orchestrated stress response occurs at various levels, but majority of story revolves around levels of cortisol. The imbalances in cortisol levels are good predictors of over activated stress axis. The cross-play of this hormone is also appreciated in metabolic disorders particularly diabetes and obesity. In addition, recent involvement of adiponectin is a collagen-like plasma protein secreted by adipocytes is also suggested to play a substantial role in the development of insulin resistance, obesity and depression. The protein has been found to be decreased in cases of insulin resistance, diabetes, and depression, but what is the degree of reduction; the answer to this question is still unknown.

 

Thus, if we can identify how the levels of biochemical which can differentiate people with obese diabetic with and without depression, that can certainly help in diagnosis and prognosis of these co-morbid conditions.

 The most probable biochemicals that link all these three comorbid conditions are cortisol and adiponectin. It has been shown that adiponectin levels are lowered and cortisol level are increased in diabetes, obesity and depression cases individually, however how their levels in cases of co-morbid (all three disease conditions) conditions are affected in entirety and the information regarding modulation of adiponectin in diabetic and obese patients that will develop or not develop depression is unknown.

 After informed consent is obtained from eligible patients, patients will be asked to fill two questionnaires on patient health and stress inventory. All questions and doubts raised by patients will be answered appropriately. A blood sample will be obtained in the morning empty stomach to assess the levels of cortisol and adiponectin. Data on patients concomitant medicationand concurrent illnesses will be recorded. 

 
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