UMIN-CTR Clinical Trial

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

Diabetes
Functional dyspepsia

Classification by specialty

Gastroenterology

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

YES

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

Primary outcomes

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

Key secondary outcomes

Study type

Interventional

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

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

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

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

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

Institute

Hyogo College of Medicine

Institute

Department

Personal name

Organization

Hyogo College of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

09

Month

02

Day

Last modified on

2018

Year

09

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033089