Stress associated changes in Patients With Type 2 Diabetes Mellitus and Obesity

Not Applicable

Completed

• Conditions: Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

• Registration Number: CTRI/2017/08/009422
• Lead Sponsor: Jamia Hamdard UNiversity

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-12-20
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 158

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To identify depressive and non-depressive population among diabetic obese patients dependent on differential levels of cortisol and/or adiponectin. <br/ ><br>2. To evaluate the effect of oral hypoglycemic drugs on the levels of adiponectin and cortisol. <br/ ><br>Timepoint: 1.To identify depressive and non-depressive population among diabetic obese patients dependent on differential levels of cortisol and/or adiponectin. <br/ ><br>2.To evaluate the effect of oral hypoglycemic drugs on the levels of adiponectin and cortisol. <br/ ><br>