| 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
|
|
|
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
|
|
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. |