T2DMNCT03564431
The Imaging Genetic Study of Type 2 Diabetes and Depression
An observational study of T2DM, run by Kunming Medical University at 1 site in China.
Trial summary
To investigate the structural/functional abnormalities and the possible genetic endophenotypes of in the Type 2 Diabetes Patient With Depression. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- T2DM
- What is being tested?
- Magnetic resonance
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 1 Dec 2020
- Phase
- Observational
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: T2DM and depression patients
Who may be able to join
- conform to type 2 diabetes, depression, diagnostic criteria of unrelated normal controls the han nationality patients; Aged 30 to 70 years of age, gender not limited; The patient or legal guardian have signed informed consent of patients.
Who cannot join
- Magnetic resonance imaging has the contraindication, such as metal implants, claustrophobic, etc.
- With severe body diseases, including inflammatory diseases and autoimmune diseases; Current or past history of nervous system disease or brain injury. Merge other severe mental illness or existing psychotic symptoms; Always have a mania, hypomania attack; Has a history of substance abuse; Pregnant women and nursing mothers; Estimated compliance is poorer, not partners; Is being treated for a mental drug therapy, and ECT, TMS; Patients with a body mass index > 35; There are currently no taking corticosteroids, immune regulator, etc. Now or ever did not suffer from patients with other diagnosis to the dsm-iv axis I; Merge the endocrine system disease, thyroid, adrenal gland and pituitary gland diseases, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Psychiatry department, The 1st Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Xiufeng Xu, MD, 8687165324888, xfxu2004@sina.com
About this study
Official title: The Study of Structural and Functional Brain Abnormalities and the Association With the Genetic Polymorphism in the Type 2 Diabetes Patient With Depression
To investigate the structural/functional abnormalities and the possible genetic endophenotypes of in the Type 2 Diabetes Patient With Depression.
Read the detailed description
Diabetes and depression are harmful to human health,but they often co-exist.At present, the pathophysiological mechanisms underlying the comorbidity of diabetes and depression are discussed, including hypothalamic-pituitary-adrenal axis dysfunction, inflammation, epigenetics, disturbed circadian rhythms, environmental and behavioral factors,neuroimaging,etc.the purpose of the investigator's study is to investigate the structural/functional abnormalities and the possible genetic endophenotypes of in the Type 2 Diabetes Patient With Depression.
- Conditions
- T2DM
- Being tested
- Magnetic resonance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonanceDevice
magnetic resonance spectrum of brain
| Study group | Role | What they receive |
|---|---|---|
| controls | Not described Receives: Device: Magnetic resonance | |
| T2DM patients | Not described Receives: Device: Magnetic resonance | |
| depression patients | Not described Receives: Device: Magnetic resonance | |
| T2DM with depression patients | Not described Receives: Device: Magnetic resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
the neuroimaging of Type 2 Diabetes and Depression
the structure and function of Abnormalities in the T2DM Patients
Measured: from 2017-12 to 2019-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start1 Dec 2017
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for T2DMStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuqi Cheng, Kunming Medical University
- Investigators
- Xiufeng Xu, MD, Principal investigator, Psychiatry department of KMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564431
- Sponsor's protocol ID
- 841026
- Status last verified
- Sep 2019
- First submitted
- 11 Jun 2018
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cui F, Ouyang ZQ, Zeng YZ, Ling BB, Shi L, Zhu Y, Gu HY, Jiang WL, Zhou T, Sun XJ, Han D, Lu Y. Effects of hypertension on subcortical nucleus morphological alternations in patients with type 2 diabetes. Front Endocrinol (Lausanne). 2023 Sep 13;14:1201281. doi: 10.3389/fendo.2023.1201281. eCollection 2023.
PubMed 37780620
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Structural and Functional Brain Abnormalities and the Association With the Genetic Polymorphism in the Type 2 Diabetes Patient With Depression
- ClinicalTrials.gov ID
- NCT03564431
- Acronym / sponsor ID
- 841026
- Conditions
- T2DM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kunming Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 20 Jun 2018 (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.
To investigate the structural/functional abnormalities and the possible genetic endophenotypes of in the Type 2 Diabetes Patient With Depression.
Detailed description
Diabetes and depression are harmful to human health,but they often co-exist.At present, the pathophysiological mechanisms underlying the comorbidity of diabetes and depression are discussed, including hypothalamic-pituitary-adrenal axis dysfunction, inflammation, epigenetics, disturbed circadian rhythms, environmental and behavioral factors,neuroimaging,etc.the purpose of the investigator's study is to investigate the structural/functional abnormalities and the possible genetic endophenotypes of in the Type 2 Diabetes Patient With Depression.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| controls | – | Device: Magnetic resonance |
| T2DM patients | – | Device: Magnetic resonance |
| depression patients | – | Device: Magnetic resonance |
| T2DM with depression patients | – | Device: Magnetic resonance |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- T2DM and depression patients
Key inclusion criteria (1 listed)
- conform to type 2 diabetes, depression, diagnostic criteria of unrelated normal controls the han nationality patients; Aged 30 to 70 years of age, gender not limited; The patient or legal guardian have signed informed consent of patients.
Key exclusion criteria (2 listed)
- Magnetic resonance imaging has the contraindication, such as metal implants, claustrophobic, etc.
- With severe body diseases, including inflammatory diseases and autoimmune diseases; Current or past history of nervous system disease or brain injury. Merge other severe mental illness or existing psychotic symptoms; Always have a mania, hypomania attack; Has a history of substance abuse; Pregnant women and nursing mothers; Estimated compliance is poorer, not partners; Is being treated for a mental drug therapy, and ECT, TMS; Patients with a body mass index > 35; There are currently no taking corticosteroids, immune regulator, etc. Now or ever did not suffer from patients with other diagnosis to the dsm-iv axis I; Merge the endocrine system disease, thyroid, adrenal gland and pituitary gland diseases, etc.
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 |
|---|---|---|
| Magnetic resonancemagnetic resonance spectrum of brain | Device | T2DM patients, T2DM with depression patients, controls, depression patients |
Primary outcome
the neuroimaging of Type 2 Diabetes and Depression
Time frame: from 2017-12 to 2019-12
the structure and function of Abnormalities in the T2DM Patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Derived from this study: PubMed 37780620Cui F, Ouyang ZQ, Zeng YZ, Ling BB, Shi L, Zhu Y, Gu HY, Jiang WL, Zhou T, Sun XJ, Han D, Lu Y. Effects of hypertension on subcortical nucleus morphological alternations in patients with type 2 diabetes. Front Endocrinol (Lausanne). 2023 Sep 13;14:1201281. doi: 10.3389/fendo.2023.1201281. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Xiufeng Xu, MD principal investigator
Psychiatry department of KMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of T2DM, run by Kunming Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 17 Sep 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Shi, MD (8687165324888, shili1026@163.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the neuroimaging of Type 2 Diabetes and Depression (time frame: from 2017-12 to 2019-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03564431, which also lists 1 linked publication.
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 17 Sep 2019.