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In order to response the increasing of aging population cause losing ability that need long-care needs, the project entitled "10-year long-term care program" from Executive Yuan in 2007 is carried out to assist economically disadvantaged and disabled elderly to acquire daily nutrition. Therefore, the long-term care resident's nutritional status got more attention than before. Out of control in blood glucose will not only increase bed sores and urinary tract infection in tube feeding residents but also rise medical expenditures. The nutritional status of long-term care institutions, anyang homes and nursing home are generally bad in nutrition management due to high cost of nutritional supplements from foreign imports that cause the burden of families. In this study, we will recruit diabetic subjects that divide into white sweet potato group (experimental group) and commercial formula group (control group) by using randomized, parallel and open clinical study through tube feeding in sixty days.
All subjects will be evaluated the blood sugar and clinical nutrition assessment such as postural measurement, urine test and blood biomarker examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Commercial diabetic formula |
|
| Treatment Group | Experimental | White sweet potato formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Commercial diabetic formula | Dietary Supplement | The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c After Intervention | HbA1c value after 60 days intervention in both groups | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Albumin After Intervention | Albumin value after 60 days intervention in both groups | 60 days |
| Glucose After Intervention | Glucose value after 60 days intervention in both groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chih-Han Lin, MS | Office of Human Research, Taipei Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24000051 | Background | Ooi CP, Loke SC. Sweet potato for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2013 Sep 3;2013(9):CD009128. doi: 10.1002/14651858.CD009128.pub3. | |
| 31636690 | Derived | Chen CM, Shih CK, Su YJ, Cheang KU, Lo SF, Li SC. Evaluation of white sweet potato tube-feeding formula in elderly diabetic patients: a randomized controlled trial. Nutr Metab (Lond). 2019 Oct 16;16:70. doi: 10.1186/s12986-019-0398-8. eCollection 2019. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation |
| FG001 | Treatment Group | White sweet potato formula White sweet potato formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation |
| BG001 | Treatment Group |
| 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 | HbA1c After Intervention | HbA1c value after 60 days intervention in both groups | Posted | Mean | Standard Deviation | percentage | 60 days |
|
The adverse event data were collected from the participants during intervention and assessed after 6 months.
No adverse event was happened in participants.
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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 | Control Group | Commercial diabetic formula Commercial diabetic formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation |
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Small experimental sample size and trial duration that may cause impose an obstacle in the detection of significant changes of the study measure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sing-Chung Li | Taipei Medical University | 886-2-27361661 | 6560 | sinchung@tmu.edu.tw |
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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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| White sweet potato formula | Dietary Supplement | The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation |
|
|
| 60 days |
| Total Cholesterol After Intervention | Total cholesterol value after 60 days intervention in both groups | 60 days |
| Triglyceride After Intervention | Triglyceride value after 60 days intervention in both groups | 60 days |
White sweet potato formula
White sweet potato formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Albumin After Intervention | Albumin value after 60 days intervention in both groups | Posted | Mean | Standard Deviation | g/dL | 60 days |
|
|
|
| Secondary | Glucose After Intervention | Glucose value after 60 days intervention in both groups | Posted | Mean | Standard Deviation | mg/dL | 60 days |
|
|
|
| Secondary | Total Cholesterol After Intervention | Total cholesterol value after 60 days intervention in both groups | Posted | Mean | Standard Deviation | mg/dL | 60 days |
|
|
|
| Secondary | Triglyceride After Intervention | Triglyceride value after 60 days intervention in both groups | Posted | Mean | Standard Deviation | mg/dL | 60 days |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Treatment Group | White sweet potato formula White sweet potato formula: The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation | 0 | 24 | 0 | 24 | 0 | 24 |
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| D004700 | Endocrine System Diseases |