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The aim of this study is to evaluate the effect of premeal protein-enriched bar in long-term glycemic control in patients with type 2 diabetes mellitus. Glucose levels in subjects who intake premeal protein-enriched bar with dietary modification will be compared to those in subjects who only do the dietary modification.
Forty subjects with type 2 diabetes will be recruited. Every subject will be randomized in two groups, which are premeal protein bar with dietary modification group and dietary modification only group. The study will be conducted for 12 weeks for each participants. All participants will receive diabetes diet education. Intervention group will consume protein-enriched bar before each meals (at least twice a day) and control group will follow diabetes diet education without other additional supplements. Primary outcome is change of HbA1c from baseline for 12 weeks, and secondary outcomes are changes of fasting blood glucose level, body weight, waist circumference, blood lipid level, HOMA-IR and HOMA-beta from baseline for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premeal protein group | Experimental | Premeal protein enriched bar with dietary modification |
|
| Dietary modofication only group | Other | Dietary modification only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Premeal protein enriched bar | Dietary Supplement | Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline | 0 week, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Blood Glucose Level From Baseline | 0 week, 12 weeks | |
| Change in Body Weight From Baseline | 0 week, 12 weeks | |
| Change in Waist Circumference From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young Min Cho, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group1 | Premeal protein enriched bar with dietary modification Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day). Dietary modification: Subjects in this group will follow diabetes diet education. |
| FG001 | Group2 | Dietary modification only Dietary modification: Subjects in this group will follow diabetes diet education. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group1 | Premeal protein enriched bar with dietary modification Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day). Dietary modification: Subjects in this group will follow diabetes diet education. |
| BG001 |
| 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 | Change in HbA1c From Baseline | Posted | Mean | Standard Deviation | % (HbA1c) | 0 week, 12 weeks |
|
6 months
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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 | Group1 | Premeal protein enriched bar with dietary modification Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day). Dietary modification: Subjects in this group will follow diabetes diet education. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor | Seoul National University Hospital | 82-2-2072-2217 | ymchomd@snu.ac.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2018 | Apr 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Dietary modification | Behavioral | Subjects in this group will follow diabetes diet education. |
|
| 0 week, 12 weeks |
| Change in Blood Triglyceride Level From Baseline | 0 week, 12 weeks |
| Change in Blood High-density Lipoprotein Level From Baseline | 0 week, 12 weeks |
| Change in Blood Low-density Lipoprotein Level From Baseline | 0 week, 12 weeks |
| Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline | Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is an index to estimate the insulin resistance of a subject. HOMA-IR is defined as ( glucose (mg/dl) X insulin (uIU/ml) ) / 405. | 0 week, 12 weeks |
| Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline | Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is an index to estimate the insulin resistance of a subject. HOMA-IR is defined as ( glucose (mg/dl) X insulin (uIU/ml) ) / 405. | 0 week, 12 weeks |
| Group2 |
Dietary modification only Dietary modification: Subjects in this group will follow diabetes diet education. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
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| Secondary | Change in Fasting Blood Glucose Level From Baseline | Posted | Mean | Standard Deviation | mg/dL | 0 week, 12 weeks |
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| Secondary | Change in Body Weight From Baseline | Posted | Mean | Standard Deviation | kg | 0 week, 12 weeks |
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| Secondary | Change in Waist Circumference From Baseline | Posted | Mean | Standard Deviation | cm | 0 week, 12 weeks |
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| Secondary | Change in Blood Triglyceride Level From Baseline | Posted | Mean | Standard Deviation | mg/dL | 0 week, 12 weeks |
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| Secondary | Change in Blood High-density Lipoprotein Level From Baseline | Posted | Mean | Standard Deviation | mg/dL | 0 week, 12 weeks |
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| Secondary | Change in Blood Low-density Lipoprotein Level From Baseline | Posted | Mean | Standard Deviation | mg/dL | 0 week, 12 weeks |
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| Secondary | Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline | Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is an index to estimate the insulin resistance of a subject. HOMA-IR is defined as ( glucose (mg/dl) X insulin (uIU/ml) ) / 405. | Posted | Mean | Standard Deviation | units | 0 week, 12 weeks |
|
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|
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| Secondary | Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline | Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is an index to estimate the insulin resistance of a subject. HOMA-IR is defined as ( glucose (mg/dl) X insulin (uIU/ml) ) / 405. | Posted | Mean | Standard Deviation | units | 0 week, 12 weeks |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Group2 | Dietary modification only Dietary modification: Subjects in this group will follow diabetes diet education. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D004700 | Endocrine System Diseases |