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| Name | Class |
|---|---|
| Ministry of Higher Education, Malaysia | OTHER |
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The goal of this study is to investigate the mechanisms of impaired gastric accommodation and emptying, dysfunctional duodenum, and micro-inflammation using novel imaging techniques of SPECT/CT, gastric emptying scintigraphy, MRI, high-resolution manometry, and inflammatory biomarkers, as well as to validate these mechanisms using a therapeutic trial of neuromodulator (mirtazapine) in functional dyspepsia (FD) and health. The main objective[s] it aims to answer are:
For objectives 1-4, FD patients and healthy volunteers will be consecutively recruited, and all will undergo SPECT/CT, MRI, high-resolution manometry and biomarkers, and data acquired from these tests will be analyzed. For objective 5, the enrolled participants who did all baseline tests/markers are given mirtazapine for four weeks, and all tests/markers, except biomarkers and MRI, are repeated at the end of the trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | Experimental |
| |
| Functional Dyspepsia | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirtazapine 15 MG | Drug | Mirtazapine
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric volume (fasting and postprandial) | SPECT/CT volumetry | Fasting, 10-min. postprandial |
| Gastric emptying profile (4 hours) | Gastric emptying scintigraphy | Immediately after test meal ingestion, up to 4 hours postprandial |
| Intragastric pressure | High-resolution manometry | Fasting, up to 30-min. postprandial after reaching maximum tolerated volume |
| Measure | Description | Time Frame |
|---|---|---|
| Satiation | Satiation scale | Fasting, up to 30-min. postprandial after reaching maximum tolerated volume |
| Upper gastrointestinal symptoms | Visual analog scale |
| Measure | Description | Time Frame |
|---|---|---|
| Standardized Uptake Value (stomach) | SPECT/CT quantitative imaging | Fasting and 10-min. postprandial |
Inclusion Criteria (Healthy):
Exclusion Criteria (Healthy):
Inclusion Criteria (FD patients):
Exclusion Criteria (FD patients):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Norazlina Mat Nawi, MD, MMed | Contact | +609-7676684 | norazlina@usm.my | |
| Lee Yeong Yeh, MD, PhD | Contact | +609-7673974 | yylee@usm.my |
| Name | Affiliation | Role |
|---|---|---|
| Nashrulhaq Tagiling, MSc | Universiti Sains Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universiti Sains Malaysia | Recruiting | Kota Bharu | Kelantan | 16150 | Malaysia |
IPD sharing has yet to be discussed thoroughly with co-investigators.
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| Fasting, up to 30-min. postprandial after reaching maximum tolerated volume |
| ID | Term |
|---|---|
| D000078785 | Mirtazapine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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