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| ID | Type | Description | Link |
|---|---|---|---|
| 0620132990 | Other Identifier | SNUH Institutional Review Board |
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The aim of this study is to assess whether dietary fiber-enriched cereals effect on postprandial glucose levels and plasma glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) concentration in patients with type 2 diabetes mellitus.
Fifteen subjects with type 2 diabetes mellitus will be provided with study meals based on either dietary fiber-enriched cereals or conventional cereals upon two separate admissions in a cross-over fashion. The study meals will be provided at 6 p.m. and 10 p.m. on the day of admission, and 8 a.m. on the next day. A hamburger with coke as mixed meal will be given for lunch at noon on the second day. Blood sampling will be done every 30 minutes from 8 a.m. to 4 p.m. on the second day. The plasma levels of glucose, GLP-1, GIP, insulin, glucagon, and free fatty acid will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DF-cereal | Experimental |
|
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| conventional cereal | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary fiber-enriched cereal | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal | To see the changes in the secretion of GLP-1 with dietary fiber enriched cereal, we will calculate the AUC of the plasma total GLP-1 levels. | every 30 minutes from 8 a.m. to noon on the second day |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of Plasma Total GIP Levels After Intake of the Study Meal | every 30 minutes from 8 a.m. to noon on the second day | |
| AUC of Plasma Glucose Levels After Intake of the Study Meal | every 30 minutes from 8 a.m. to noon on the second day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young Min Cho, MD, PHD | Seoul National University College of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26839476 | Derived | Kim EK, Oh TJ, Kim LK, Cho YM. Improving Effect of the Acute Administration of Dietary Fiber-Enriched Cereals on Blood Glucose Levels and Gut Hormone Secretion. J Korean Med Sci. 2016 Feb;31(2):222-30. doi: 10.3346/jkms.2016.31.2.222. Epub 2016 Jan 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DF-cereal, Then Conventional Cereal |
after 1 week of wash-out period, subjects were re-admitted
|
| FG001 | Conventional Cereal, Then DF-cereal |
after 1 week of wash-out period, subjects were re-admitted
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | DF-cereal, Then Conventional Cereal |
after 1 week of wash-out period, subjects were re-admitted
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal | To see the changes in the secretion of GLP-1 with dietary fiber enriched cereal, we will calculate the AUC of the plasma total GLP-1 levels. | Posted | Mean | Standard Deviation | pM x hr/L | every 30 minutes from 8 a.m. to noon on the second day |
|
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The definition of adverse event and serious adverse event was not differ from clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DF-cereal |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Youn Min Cho, M.D, PhD | Seoul National University College of Medicine | +82-2-2072-1965 | ymchomd@snu.ac.kr |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| conventional cereal | Other |
|
|
| AUC of Plasma Insulin Levels After Intake of the Study Meal | every 30 minutes from 8 a.m. to noon on the second day |
| AUC of Plasma Glucagon Levels After Intake of the Study Meal | every 30 minutes from 8 a.m. to noon on the second day |
| AUC of Serum Free Fatty Acid Levels After Intake of the Study Meal | every 30 minutes from 8 a.m. to noon on the second day |
| AUC of Plasma Total GIP Levels After Lunch | every 30 minutes from noon to 4 p.m. on the second day |
| AUC of Plasma Glucose Levels After Lunch | every 30 minutes from noon to 4 p.m. on the second day |
| AUC of Plasma Insulin Levels After Lunch | every 30 minutes from noon to 4 p.m. on the second day |
| AUC of Plasma Glucagon Levels After Lunch | every 30 minutes from noon to 4 p.m. on the second day |
| AUC of Serum Free Fatty Acid Levels After Lunch | every 30 minutes from noon to 4 p.m. on the second day |
| AUC of Plasma Total GLP-1 Levels After Lunch | every 30 minutes from noon to 4 p.m. on the second day |
| BG001 | Conventional Cereal, Then DF-cereal |
after 1 week of wash-out period, subjects were re-admitted
|
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| HbA1c | Mean | Standard Deviation | % of glycated hemoglobin |
|
| OG001 | Conventional Cereal |
conventional cereal: - provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)
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| Secondary | AUC of Plasma Total GIP Levels After Intake of the Study Meal | Not Posted | every 30 minutes from 8 a.m. to noon on the second day | Participants |
| Secondary | AUC of Plasma Glucose Levels After Intake of the Study Meal | Not Posted | every 30 minutes from 8 a.m. to noon on the second day | Participants |
| Secondary | AUC of Plasma Insulin Levels After Intake of the Study Meal | Not Posted | every 30 minutes from 8 a.m. to noon on the second day | Participants |
| Secondary | AUC of Plasma Glucagon Levels After Intake of the Study Meal | Not Posted | every 30 minutes from 8 a.m. to noon on the second day | Participants |
| Secondary | AUC of Serum Free Fatty Acid Levels After Intake of the Study Meal | Not Posted | every 30 minutes from 8 a.m. to noon on the second day | Participants |
| Secondary | AUC of Plasma Total GIP Levels After Lunch | Not Posted | every 30 minutes from noon to 4 p.m. on the second day | Participants |
| Secondary | AUC of Plasma Glucose Levels After Lunch | Not Posted | every 30 minutes from noon to 4 p.m. on the second day | Participants |
| Secondary | AUC of Plasma Insulin Levels After Lunch | Not Posted | every 30 minutes from noon to 4 p.m. on the second day | Participants |
| Secondary | AUC of Plasma Glucagon Levels After Lunch | Not Posted | every 30 minutes from noon to 4 p.m. on the second day | Participants |
| Secondary | AUC of Serum Free Fatty Acid Levels After Lunch | Not Posted | every 30 minutes from noon to 4 p.m. on the second day | Participants |
| Secondary | AUC of Plasma Total GLP-1 Levels After Lunch | Not Posted | every 30 minutes from noon to 4 p.m. on the second day | Participants |
| 0 |
| 13 |
| 0 |
| 13 |
| 7 |
| 13 |
| EG001 | Conventional Cereal |
| 0 | 13 | 0 | 13 | 0 | 13 |
| increased gas-out | Gastrointestinal disorders | Systematic Assessment |
|
| increased amount and number of defecation | Gastrointestinal disorders | Systematic Assessment |
|
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