CTRI

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CTRI Number

CTRI/2023/10/059060 [Registered on: 23/10/2023] Trial Registered Prospectively

Last Modified On:

07/11/2024

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Assessment of Risk of Depression, Anxiety, and Stress among Type-2 Diabetic Patients on Oral Antidiabetics.

Scientific Title of Study

Assessment of Risk of Depression, Anxiety, and Stress among Type-2 Diabetic Patients on Oral Antidiabetic Agents : A Cross-sectional Study.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Eva Jessica Dsouza
Designation	PharmD Student
Affiliation	NGSM Institute of Pharmaceutical sciences
Address	Department of Pharmacy Practice NGSM Institute of pharmaceutical sciences, Derlakatte, Mangalore Dakshina Kannada KARNATAKA 575018 India
Phone	9481676894
Fax
Email	dsouzajessica14@gmail.com

Details of Contact Person
Scientific Query

Name	Roopa Satyanarayan Basutkar
Designation	Assistant Professor
Affiliation	NGSM Institute of Pharmaceutical Sciences
Address	Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangalore Dakshina Kannada KARNATAKA 575018 India
Phone	9047155003
Fax
Email	roopa.satyanarayan@nitte.edu.in

Details of Contact Person
Public Query

Name	Roopa Satyanarayan Basutkar
Designation	Assistant Professor
Affiliation	NGSM Institute of Pharmaceutical Sciences
Address	Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangalore Dakshina Kannada KARNATAKA 575018 India
Phone	9047155003
Fax
Email	roopa.satyanarayan@nitte.edu.in

Source of Monetary or Material Support

Justice K S Hegde Charitable Hospital, Mangalore

Primary Sponsor

Name	Justice K S Hegde Charitable Hospital
Address	Deralakatte, Mangalore -575018
Type of Sponsor	Private hospital/clinic

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Roopa Satyanarayan Basutkar	Justice K. S. Hegde Charitable Hospital	Outpatient Department of Endocrinology and General Medicine Dakshina Kannada KARNATAKA	9047155003 roopa.satyanarayan@nitte.edu.in

Details of Ethics Committee

No of Ethics Committees= 2
Name of Committee	Approval Status
NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC)	Approved
NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E116\|\|Type 2 diabetes mellitus with other specified complications,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	1. Subjects on metformin+sulphonylureas/SGLT2I+other OHAs/DPP4I+other OHAs for at least 30 days prior to enrolment in the study 2. Participants who are willing to give consent.

ExclusionCriteria

Details

1. T2DM patients with life-threatening
complications
2. Pregnant women
3. Patients taking SGLT2I, DPP4I in combination.
4. Patients who are severely disabled, deaf, or
mute
5. Patients taking antidepressants
6. Patients with:
(i)Neurological or severe psychiatric disease
(ii)Depression or anxiety with onset prior to
starting OHAs.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Depression	At baseline visit

Secondary Outcome

Outcome	TimePoints
FBS PPBS RBS HbA1C BP HDL LDL TGs TC	At baseline visit

Target Sample Size

Total Sample Size="225"
Sample Size from India="225"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

30/10/2023

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Closed to Recruitment of Participants

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Type 2 diabetes mellitus (T2DM) and depression are prevalent conditions associated with limitations in daily functioning, reduced quality of life, and increased mortality rates. The occurrence and diagnosis of depression in individuals with T2DM have risen significantly, with research indicating that T2DM can lead to twice the likelihood of developing depression. Three biological pathways have been emphasized to cause depression in T2DM patients. First, it has been discovered that depressed symptoms are linked to hyperglycemia as determined by HbA1C. Secondly, various cell investigations, studies on animals, and clinical studies on humans have pointed to insulin resistance as the factor connecting depression and diabetes. Thirdly, increased inflammation has been observed in both diabetic and depressed patients. The hypothesis suggests that antidiabetic medications could potentially reduce the occurrence of depression in diabetic patients, as many of these drugs have impacts on all three pathways. Previous studies have shown that using any oral anti-diabetic medicine reduces the likelihood of developing depression. Our study specifically aims to assess the proportion of depression, anxiety, and stress among T2DM patients who are on metformin+sulphonylureas v/s SGLT2I+other OHAs v/s DPP4I+other OHAs.