Evaluation of Stress and Associated Biochemical Changes in Patients With type 2 Diabetes Mellitus and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- 1. To identify depressive and non-depressive population among diabetic obese patients dependent on differential levels of cortisol and/or adiponectin.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
1. To identify depressive and non-depressive population among diabetic obese patients dependent on differential levels of cortisol and/or adiponectin.
时间窗: 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.
2. To evaluate the effect of oral hypoglycemic drugs on the levels of adiponectin and cortisol.
时间窗: 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.
次要结局
- 1.Identify stress susceptible and stress resilient population among patients using questionnaire(2.Identify depressive and non-depressive population among patients using PHQ-9)
- •Identify stress susceptible and stress resilient population among patients using questionnaire(•Identify depressive and non-depressive population among patients using PHQ-9)