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Molecular pathological changes in the duodenal mucosa in patients with diabetes or functional dyspepsia

Molecular pathological changes in the duodenal mucosa in patients with diabetes or functional dyspepsia - Molecular pathological changes in the duodenal mucosa in patients with diabetes or functional dyspepsia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028974
Enrollment
60
Registered
2017-10-01
Start date
2017-09-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Functional dyspepsia

Interventions

Endoscopic biopsy

Sponsors

Hyogo College of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

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

Countries

Japan

Contacts

Public ContactHirokazu Fukui

Hyogo College of Medicine Division of Gastroenterology, Department of Internal Medicine

hfukui@hyo-med.ac.jp0998-45-6662

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026