Back to resultsBDNF Level and val66met Polymorphism of Brain Derived Neurotropic Factor Gene in Patients With T2DM and Depression
Primary Purpose
Depression, Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Questionare
Sponsored by
About this trial
This is an interventional screening trial for Depression focused on measuring Brain Derived Neurotrophic Factor, Diabetes Mellitus
Eligibility Criteria
Adult patients who have type two diabetes with or without depression.
Sites / Locations
- Cairo university hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients with type 2 Diabetes Mellitus and depression
Patients with type 2 Diabetes Mellitus and no depression
Arm Description
This arm includes patients with type 2 diabetes mellitus that were diagnosed with depression using structured clinical interview for DSM-IV Axis disorder (SCID-I) and Hamilton Depression Rating Scale (HAM-D) for diagnosing depression and exclusion of other psychiatric disorders.
This arm includes patients with type 2 diabetes mellitus where depression was ruled out using structured clinical interview for DSM-IV Axis disorder (SCID-I) and Hamilton Depression Rating Scale (HAM-D) for diagnosing depression and exclusion of other psychiatric disorders.
Outcomes
Primary Outcome Measures
BDNF level in blood
Measurement of the level of BDNF in blood
val66met polymorphism of BDNF gene
Measurement of val66met polymorphism of BDNF gene
Secondary Outcome Measures
Full Information
NCT ID
NCT05526131
First Posted
August 31, 2022
Last Updated
September 1, 2022
Sponsor
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05526131
Brief Title
BDNF Level and val66met Polymorphism of Brain Derived Neurotropic Factor Gene in Patients With T2DM and Depression
Official Title
Brain Derived Neurotropic Factor Level and val66met Polymorphism of Brain Derived Neurotropic Factor Gene in Patients With Type Two Diabetes Mellitus and Depression
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
October 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed to evaluate the relation between the levels of (Brain Derived Neurotropic Factor) BDNF and val66met polymorphism of BDNF gene, and the presence of depression in type 2 diabetes. In addition to studying the relationship between BDNF level and val66met polymorphism of its gene and assessing relation between BDNF level and obesity.
Detailed Description
The study included 88 type 2 diabetic patients, which are further divided into two groups; depressed and non-depressed. Depression was assessed by Hamilton Depression Rating Scale (HAM-D) and structured clinical interview for DSM-IV Axis disorder (SCID-I) for diagnosing depression and exclusion of other psychiatric disorders. Genotyping was performed by using Real Time-PCR (TaqMan probes).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Diabetes Mellitus
Keywords
Brain Derived Neurotrophic Factor, Diabetes Mellitus
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with type 2 Diabetes Mellitus and depression
Arm Type
Active Comparator
Arm Description
This arm includes patients with type 2 diabetes mellitus that were diagnosed with depression using structured clinical interview for DSM-IV Axis disorder (SCID-I) and Hamilton Depression Rating Scale (HAM-D) for diagnosing depression and exclusion of other psychiatric disorders.
Arm Title
Patients with type 2 Diabetes Mellitus and no depression
Arm Type
Active Comparator
Arm Description
This arm includes patients with type 2 diabetes mellitus where depression was ruled out using structured clinical interview for DSM-IV Axis disorder (SCID-I) and Hamilton Depression Rating Scale (HAM-D) for diagnosing depression and exclusion of other psychiatric disorders.
Intervention Type
Other
Intervention Name(s)
Questionare
Intervention Description
Assessing the presence or the absence of depression:
By structured clinical interview for DSM-IV Axis disorder (SCID-I) and Hamilton Depression Rating Scale (HAM-D) for diagnosing depression and exclusion of other psychiatric disorders.
Primary Outcome Measure Information:
Title
BDNF level in blood
Description
Measurement of the level of BDNF in blood
Time Frame
1 day (At the time of recruitment)
Title
val66met polymorphism of BDNF gene
Description
Measurement of val66met polymorphism of BDNF gene
Time Frame
1 day (At the time of recruitment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Adult patients who have type two diabetes with or without depression.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Abdelaziz, PhD
Organizational Affiliation
Kasr Alaini University Hsopitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo university hospitals
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
BDNF Level and val66met Polymorphism of Brain Derived Neurotropic Factor Gene in Patients With T2DM and Depression
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