DepressionNCT05526131
BDNF Level and val66met Polymorphism of Brain Derived Neurotropic Factor Gene in Patients With T2DM and Depression
A study testing Questionare in people with Depression and Diabetes Mellitus, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Diabetes Mellitus
- What is being tested?
- Questionare
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Feb 2021to 23 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Adult patients who have type two diabetes with or without depression.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Depression, Diabetes Mellitus
- Being tested
- Questionare
- Keywords
- Brain Derived Neurotrophic Factor, Diabetes Mellitus
- Medical subject headings
- Depression, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Questionare |
What is being measured
The primary outcome is the main question the study is designed to answer.
BDNF level in blood
Measurement of the level of BDNF in blood
Measured: 1 day (At the time of recruitment)
val66met polymorphism of BDNF gene
Measurement of val66met polymorphism of BDNF gene
Measured: 1 day (At the time of recruitment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start17 Feb 2021
- Primary completion20 Sep 2021
- Study completion23 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Samy Abdelaziz, Kasr El Aini Hospital
- Investigators
- Tarek Abdelaziz, PhD, Principal investigator, Kasr Alaini University Hsopitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526131
- Sponsor's protocol ID
- KA-239-D
- Status last verified
- Aug 2022
- First submitted
- 31 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05526131
- Acronym / sponsor ID
- KA-239-D
- Conditions
- Depression, Diabetes Mellitus
- Keywords
- Brain Derived Neurotrophic Factor, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 23 Oct 2021 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 Diabetes Mellitus and depression | Active comparator | Other: QuestionareThis 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. |
| Patients with type 2 Diabetes Mellitus and no depression | Active comparator | Other: QuestionareThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionareAssessing 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. | Other | Patients with type 2 Diabetes Mellitus and depression, Patients with type 2 Diabetes Mellitus and no depression |
Primary outcome
BDNF level in blood
Time frame: 1 day (At the time of recruitment)
Measurement of the level of BDNF in blood
val66met polymorphism of BDNF gene
Time frame: 1 day (At the time of recruitment)
Measurement of val66met polymorphism of BDNF gene
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Abdelaziz, PhD principal investigator
Kasr Alaini University Hsopitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionare in people with Depression and Diabetes Mellitus, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDNF level in blood (time frame: 1 day (At the time of recruitment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.