BDNF Level and val66met Polymorphism of Brain Derived Neurotropic Factor Gene in Patients With T2DM and Depression

September 1, 2022 updated by: Tarek Samy Abdelaziz, Kasr El Aini Hospital

Brain Derived Neurotropic Factor Level and val66met Polymorphism of Brain Derived Neurotropic Factor Gene in Patients With Type Two Diabetes Mellitus and Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Adult patients who have type two diabetes with or without depression.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Patients with type 2 Diabetes Mellitus and depression
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.
Other: Questionare

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.
ACTIVE_COMPARATOR: Patients with type 2 Diabetes Mellitus and no depression
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.
Other: Questionare

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BDNF level in blood
Time Frame: 1 day (At the time of recruitment)
Measurement of the level of BDNF in blood
1 day (At the time of recruitment)
val66met polymorphism of BDNF gene
Time Frame: 1 day (At the time of recruitment)
Measurement of val66met polymorphism of BDNF gene
1 day (At the time of recruitment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: Tarek Abdelaziz, PhD, Kasr Alaini University Hsopitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 17, 2021

Primary Completion (ACTUAL)

September 20, 2021

Study Completion (ACTUAL)

October 23, 2021

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (ACTUAL)

September 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2022

Last Update Submitted That Met QC Criteria

September 1, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA-239-D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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