Gut Hormone, Nociceptors, Neurotrophic Factors Expression in Functional Dyspepsia

Functional Dyspepsia Clinical Trial

— FD  

Official title:

Ghrelin, Leptin, Serotonin, TRPV1, NGF and GDNF Expression in the Patients With Functional Dyspepsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173925
• Other study ID #: B-1101/119-010
• Status: Completed
• Phase: N/A
• First received: June 13, 2014
• Last updated: January 5, 2015
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The pathophysiology of functional dyspepsia is still unclear but several peptides have been indicated in the etiological factors in FD. Ghrelin and leptin are involved in regulation of appetite and gut motility and serotonin is a typical neurotransmitter related with sensory and motor functions of gut. On the other hand, transient receptor potential vanilloid receptor 1 (TRPV1) has been proposed to be involved with functional gastrointestinal disorder, and expression of this receptor could be regulated by nerve growth factor (NGF) or glial cell-line derived neurotrophic factor (GDNF). The investigators aimed to determine whether expressions of ghrelin,leptin, serotonin,TRPV1,GDNF and NGF in blood or gastric mucosa of FD patients are different from those in healthy controls, and whether some changes of their expression correlate with certain dyspeptic symptoms. The investigators also investigated the effect of H. pylori infection by comparing their expressions before and one year after H. pylori eradication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subjects who completed upper GI endoscopy and questionnaire about gastrointestinal symptoms

Exclusion Criteria:

• Daily user of NSAID or anticoagulants

• with concomitant systemic diseases such as diabetes mellitus or any malignancy

• Participants with major depression, psychosis, eating disorder

• Participants with typical reflux symptom

• Patients with Benign gastric ulcer or duodenal ulcer

• Patients with past gastrointestinal surgery

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis
• H. Pylori Infection
• Helicobacter Infections

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of fasting plasma acyl ghrelin		Baseline	No
Secondary	Change of gastric mRNA ghrelin, leptin, TRPV1, NGF and GDNF expression and blood level of acyl ghrelin, leptin and serotonin		Baseline/ 1year	No
Secondary	Expression of gastric ghrelin, leptin, TRPV1, NGF and GDNF mRNA and blood level of des-acyl ghrelin and serotonin		Baseline	No