Effect of Genetic Association With Functional Dyspepsia and Mood Disorders (FDFDR)
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|ClinicalTrials.gov Identifier: NCT02282995|
Recruitment Status : Recruiting
First Posted : November 5, 2014
Last Update Posted : April 25, 2017
Functional dyspepsia (FD) is one of the commonest digestive disorders. The pathophysiology of functional dyspepsia is uncertain. Risk factors include genetics, gender, age, helicobacter pylori infection, etc. However, few reported the association of genetic contribution to the development of FD and mood disorder.
Functional dyspepsia patients
Prince of Wales Hospital, Hong Kong
- To evaluate genetic factors on development of functional dyspepsia & common mood disorders
- To evaluate genetic factors on the severity of function dyspepsia & mood disorders
- To develop a diagnostic test for classification of functional dyspepsia by plasma ghrelin and serotonin expression
- To collect sleep data for future use
- To save blood sample for future retrospective diagnostic or genetic examination
Case-control cross sectional study
Number of subjects:
Total of 1200 subjects (300 FD patients + 300 relatives of FD patients FDR) and (300 Controls + 300 FDR)
Functional dyspepsia patients age 18-60
Duration of study:
1 May 2012 - 30 April 2013
Genetic polymorphisms of targeted genes, plasma ghrelin and serotonin expression
FD global symptom assessment and symptom scores
Number of visits: 1
- Shared genetic factors contribute to the development of FD and common psychological disorders
- FD patients contribute to suppression of plasma ghrelin and serotonin expression compared to healthy controls
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Effect of Genetic Association With Functional Dyspepsia and Mood Disorders|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
•FDR-Relatives of FD patients
Relatives of FD patients. Patients may bring at most two FDRs to participate in this study.
Healthy control. Controls who are self-referred to this study will be recruited.
•FD-Patients with FD
Patients with FD. Patients referred for OGD in Endoscopy Center, Prince of Wales Hospital, with symptoms suggestive of FGID will be invited to participate in this study.
•FDCR-Relatives of healthy controls
Relatives of healthy controls. Each participating control is required to bring at least one and up to two FDRs to participate in this study.
- Differences of genetic polymorphism in targeted genes in patients with FD and mood disorders [ Time Frame: up to 48 months ]Differences of genetic polymorphism in targeted genes in patients with FD and mood
- Diagnosis of psychiatric disorder with PHQ and HADS [ Time Frame: up to 48 months ]Diagnosis of psychiatric disorder with PHQ and HADS
- Differences of plasma ghrelin and serotonin expression in FD patients and study controls. [ Time Frame: up to 48 months ]Differences of plasma ghrelin and serotonin expression in FD patients and study controls.
- Symptom scores [ Time Frame: up to 48 months ]Symptom scores
Biospecimen Retention: Samples With DNA
Nine ml of blood will be used for the detection of biomarkers for functional dyspepsia through single nucleotide polymorphism (SNPs). The genotyping DNA will be isolated from whole blood samples by (FlexGene DNA kit, Qiagen). High-throughput genotyping will be performed on the serotonin 3A receptor polymorphism (rs1062613) and ghrelin CLOCK 3111C polymorphism (rs1801260). It will be analyzed by Applied Biosystems (ABI) 3730xl DNA Analyzer.
Six ml of blood will be used for detection of plasma ghrelin and serotonin expression by ELISA.
The remaining blood samples will be stored in the Laboratory of Institute of Digestive Diseases for tests stated in the Aim section, also for future studies for emerging diseases related to FGID.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282995
|Contact: Justin C.Y. Wu, MBChB(CUHK)||(852)email@example.com|
|Contact: Kay Yuen, M Phil||(852)firstname.lastname@example.org|
|Prince of Wales Hospital||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Justin C.Y. Wu, MBChB(CUHK) (852)35053476 email@example.com|
|Principal Investigator: Justin C.Y. Wu, MBChB(CUHK)|
|Principal Investigator:||Justin C.Y. Wu, MBChB(CUHK)||Chinese University of Hong Kong|