Evaluation of White Sweet Potato Tube Feeding Formula on Type 2 Diabetic Residents in Long-term Care Institutions

Study Overview
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Brief Summary
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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.

Detailed Description
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All subjects will be evaluated the blood sugar and clinical nutrition assessment such as postural measurement, urine test and blood biomarker examination.

Official Title
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Office of Human Research, Taipei Medical University

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Commercial diabetic formula
* Dietary Supplement: White sweet potato formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Long-term stability nasogastric or gastrostomy-fed person. The physician diagnosed as diabetic and regular use of hypoglycemic drugs. Exclusion Criteria: Psychosis or depression. Hba1c> 8.5%. High taking nutritional supplements or steroids drugs. Have undergone abdominal surgery caused by intestinal sticky. Suffering from cancer, ulcers, respiratory infections and other diseases. Currently receiving central venous nutrition therapy or intravenous nutrition therapy. Liver dysfunction (ALT ≧ 100 U / L), renal insufficiency (creatinine ≧ 3mg / dl), heart failure (NYFc II above), moderate anemia (hemoglobin <9 g / dl).

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Commercial diabetic formula | Dietary Supplement: Commercial diabetic formula<br>* The formula were supplied 1500 1800 kcal daily depend on the patient's individual situation<br>* Other names: diabetic formula;|
| Experimental: Treatment Group<br>White sweet potato formula | Dietary Supplement: White sweet potato formula<br>* The formula were supplied 1500 1800 kcal daily depend on the patient's individual situation<br>* Other names: White sweet potato;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c After Intervention | HbA1c value after 60 days intervention in both groups | 60 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |