NCT05526131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

7 months

First QC Date

August 31, 2022

Last Update Submit

September 1, 2022

Conditions

DepressionDiabetes Mellitus

Keywords

Brain Derived Neurotrophic FactorDiabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • BDNF level in blood

    Measurement of the level of BDNF in blood

    1 day (At the time of recruitment)

  • val66met polymorphism of BDNF gene

    Measurement of val66met polymorphism of BDNF gene

    1 day (At the time of recruitment)

Study Arms (2)

Patients with type 2 Diabetes Mellitus and depression

ACTIVE COMPARATOR

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

Patients with type 2 Diabetes Mellitus and no depression

ACTIVE COMPARATOR

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

Interventions

QuestionareOTHER

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.

Patients with type 2 Diabetes Mellitus and depressionPatients with type 2 Diabetes Mellitus and no depression

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Adult patients who have type two diabetes with or without depression.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

DepressionDiabetes Mellitus

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Tarek Abdelaziz, PhD

    Kasr Alaini University Hsopitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 31, 2022

First Posted

September 2, 2022

Study Start

February 17, 2021

Primary Completion

September 20, 2021

Study Completion

October 23, 2021

Last Updated

September 2, 2022

Record last verified: 2022-08

Locations

EG(1)