NCT03564431

Brief Summary

To investigate the structural/functional abnormalities and the possible genetic endophenotypes of in the Type 2 Diabetes Patient With Depression.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

June 11, 2018

Last Update Submit

September 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • the neuroimaging of Type 2 Diabetes and Depression

    the structure and function of Abnormalities in the T2DM Patients

    from 2017-12 to 2019-12

Study Arms (4)

controls

Device: Magnetic resonance

T2DM patients

Device: Magnetic resonance

depression patients

Device: Magnetic resonance

T2DM with depression patients

Device: Magnetic resonance

Interventions

magnetic resonance spectrum of brain

T2DM patientsT2DM with depression patientscontrolsdepression patients

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

T2DM and depression patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatry department, The 1st Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

perapheral blood DNA of all participants

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Xiufeng Xu, MD

    Psychiatry department of KMU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 11, 2018

First Posted

June 20, 2018

Study Start

December 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

September 17, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations