Effect of Genetic Association With Functional Dyspepsia and Mood Disorders

NCT02282995 | Unknown

• 1 other identifier: FDFDR
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

Background: 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. Indication: Functional dyspepsia patients Study center(s): Prince of Wales Hospital, Hong Kong Aims:

• 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 Study design: 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) Patient population: Functional dyspepsia patients age 18-60 Duration of study: 1 May 2012 - 30 April 2013 Primary variable(s): Genetic polymorphisms of targeted genes, plasma ghrelin and serotonin expression Secondary variable(s): FD global symptom assessment and symptom scores Number of visits: 1 Hypotheses:
• 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

Conditions

Dyspepsia

Keywords

Functional dyspepsia; symptom response

Outcome Measures

Primary Outcomes (1)

• Differences of genetic polymorphism in targeted genes in patients with FD and mood disorders

  Differences of genetic polymorphism in targeted genes in patients with FD and mood

  up to 48 months

Secondary Outcomes (3)

• Diagnosis of psychiatric disorder with PHQ and HADS

  up to 48 months

• Differences of plasma ghrelin and serotonin expression in FD patients and study controls.

  up to 48 months

• Symptom scores

  up to 48 months

Study Arms (4)

•FDR-Relatives of FD patients

Relatives of FD patients. Patients may bring at most two FDRs to participate in this study. * Up to 20 ml of fasting blood sample will be collected * Serology test of Hp status will be performed for healthy volunteers and all FDRs

•FDC-Healthy control

Healthy control. Controls who are self-referred to this study will be recruited. * Up to 20 ml of fasting blood sample will be collected * Fasting glucose test will be performed for FD patients * Serology test of Hp status will be performed for healthy volunteers and all FDRs

•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. * Up to 20 ml of fasting blood sample will be collected * Fasting glucose test will be performed for FD patients

•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. * Up to 20 ml of fasting blood sample will be collected * Serology test of Hp status will be performed for healthy volunteers and all FDRs

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for OGD in Endoscopy Center, Prince of Wales Hospital, with symptoms suggestive of FGID or who participated in PI's previous clinical trials will be invited to participate in this study as FD patients. Patients not suffering from FGID will be identified from the gastrointestinal specialty clinic or Endoscopy Center, Prince of Wales Hospital as healthy volunteers. These patients may include those referred for GI malignancy screening. Study advertisement will be posted in public area of Prince of Wales Hospital, and on the educational website (www.digestion.hk) which is maintained by PI. Controls who are self-referred to this study will be recruited.

You may qualify if:

• All subject
• Age 18-60
• Provision of written consent
• Additional to FD patient
• Symptoms fulfilling Rome III criteria of functional dyspepsia
• Negative upper endoscopy (oesophagogastroduodenoscopy or OGD) finding

You may not qualify if:

• All subject
• History of cancer
• Diabetes mellitus
• History of gastric surgery
• Acid suppressants or medications that affect motility in past 4 weeks
• Organic disease as cause of dyspepsia (for subjects with dyspeptic symptom)
• Additional to healthy volunteer
• Any gastrointestinal symptoms (including acid regurgitation, heartburn, epigastric pain, bloating sensation, constipation, abdominal pain, diarrhea) in the past 4 weeks
• Additional to FD patient
• Frequent (once or more per week) acid reflux or heartburn symptoms
• Helicobacter pylori (Hp) infection

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Links

• The Chinese University of Hong Kong

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.

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Justin C.Y. Wu, MBChB(CUHK)

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin C.Y. Wu, MBChB(CUHK)

CONTACT

(852)35053476; justinwu@cuhk.edu.hk

Kay Yuen, M Phil

CONTACT

(852)35053476; kayyuen@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: November 5, 2014
• Study Start: August 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)