Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients who have given written informed consent for study participation 2.Males and females patients aged >18 years and 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 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
| Measure | Time frame |
|---|---|
| 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 Timepoint: After complete enrollment;ââ?¬Â¢Identify stress susceptible and stress resilient population among patients using questionnaire ââ?¬Â¢Identify depressive and non-depressive population among patients using PHQ-9 ââ?¬Â¢Change in cortisol and/or adiponectin levels with depression ââ?¬Â¢Results of bimodal populations obtained from stress-questionnaire, depression questionnaire, cortisol/adiponectin levels ââ?¬Â¢Evaluate the reliability of adiponectin and cortisol levels in identifying depressive phenotypes among diabetic obese patientsTimepoint: after complete enrollment | — |
Countries
India
Contacts
Jamia Hamdard