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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028974
Receipt No. R000033089
Scientific Title Molecular pathological changes in the duodenal mucosa in patients with diabetes or functional dyspepsia
Date of disclosure of the study information 2017/10/01
Last modified on 2018/09/25

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Basic information
Public title Molecular pathological changes in the duodenal mucosa in patients with diabetes or functional dyspepsia
Acronym Molecular pathological changes in the duodenal mucosa in patients with diabetes or functional dyspepsia
Scientific Title Molecular pathological changes in the duodenal mucosa in patients with diabetes or functional dyspepsia
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroto Miwa
Organization Hyogo College of Medicine
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa, Nishinomiya, Hyogo
TEL 0998-45-6662
Email miwahgi@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirokazu Fukui
Organization Hyogo College of Medicine
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 08 Month 15 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000033089

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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