Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT04917458
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects with aged 18 and over
* Living in around Jakarta
* Type 2 diabetes mellitus patients with depression symptom
* Patients with Body mass index 20-30 m/kg2
* Patients are able and willing to maintain diet, physical activity, and lifestyle for 3 months
* Patients are able and willing to control for follow up
Exclusion Criteria:
* \- Presence of severe hepatic dysfunction, defined as cirrhosis hepatic
* Presence of severe renal dysfunction, defined as chronic kidney disease stage 5 or e-GFR ≤15 or history of hemodialysis
* Patients with acute coronary syndrome
* Presence of acute systemic inflammatory response syndrome (SIRS). The term SIRS describes a clinical state arising from a non-specific cause, infective, or otherwise
* Recent obtained vitamin D therapy within the last 3 months
* Current or regular use of corticosteroids within immunosuppressant dosage
* Presence of major depression
* Presence of psychosis
* Current or regular use of anti-depressant
* Current or regular use of phenytoin or phenobarbital
* For females: current pregnancy and lactation period
* Patients who refuse the studies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04917458
Study Brief:
Protocol Section:
NCT04917458