UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Molecular pathological changes in the duodenal mucosa in patients with diabetes or functional dyspepsia
Title of the study (Brief title)	Molecular pathological changes in the duodenal mucosa in patients with diabetes or functional dyspepsia
Region	Japan

Condition
Condition	Diabetes Functional dyspepsia
Classification by specialty	Gastroenterology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To clarify the molecular pathological changes in the duodenal mucosa in patients with diabetes or functional dyspepsia
Basic objectives2	Others
Basic objectives -Others	To investigate the relationship between molecular pathological changes and upper abdominal symptoms
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare the expression of inflammatory markers and G protein-coupled receptors among diabetes, functional dyspepsia and control subjects
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Endoscopic biopsy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Three groups: Diabetes, Functional dyspepsia and Control. 1) Outpatients (age >= 20) 2) (I) Diabetes: fasting blood sugar >= 126 mg/dl or casual blood glucose >= 200 mg/dl or HbA1c >= 6.5%. (II) Functional dyspepsia: compatible with ROME III diagnostic criteria. Requirements: [1] or [2] or both. [1] Bothersome postprandial fullness after eating a normal amount of food >= two times/week. [2] Unable to finish a normal amount of food due to early satiation >= two times/week. (III) Control: The subjects who belongs to neither (I) nor (II). 3) The patients who can understand the contents of this study and give their entry agreement to this study by documents.
Key exclusion criteria	1) Patients with malignant diseases, gastrointestinal-organic diseases (malignancies, peptic ulcers, esophagitis, etc.) or systemic diseases (neurological disease such as Parkinson disease or metabolic diseases except for diabetes). 2) Patients with a history of surgery of the upper gastrointestinal tract (stomach and esophagus). 3) Patients with severe liver dysfunction and renal dysfunction. 4) Patients with mental disorder. 5) A pregnant woman, nursing mother or the subjects who hope pregnancy during this study term. 6) Patients whom doctors judged unsuitable as objects for this study. 7) Patients with H. pylori eradication within 6 months. 8) Patients having the following medicines: prokinetic drugs, H2 blocker, proton pump inhibitor, gastric-mucosal protectant, prostaglandin, NSAIDs, anti-depressants, anti-anxiety agents, sleep inducer, anti-psychotics drugs. However, the patients, who can discontinue those medicines for two or more weeks before study start, can participate in this study.
Target sample size	60

Research contact person
Name of lead principal investigator	Hiroto Miwa
Organization	Hyogo College of Medicine
Division name	Division of Gastroenterology, Department of Internal Medicine
Address	1-1, Mukogawa, Nishinomiya, Hyogo
TEL	0998-45-6662
Email	miwahgi@hyo-med.ac.jp

Public contact
Name of contact person	Hirokazu Fukui
Organization	Hyogo College of Medicine
Division name	Division of Gastroenterology, Department of Internal Medicine
Address	1-1, Mukogawa, Nishinomiya, Hyogo
TEL	0998-45-6662
Homepage URL
Email	hfukui@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 15 Day
Anticipated trial start date	2017 Year 09 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 02 Day
Last modified on	2018 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033089