Clinical trial NCT02711839: Evaluation of White Sweet Potato Tube Feeding Formula on Type 2 Diabetic Residents in Long-term Care Institutions
Official title: Office of Human Research, Taipei Medical University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 54
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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).

Primary outcomes:
measure: HbA1c After Intervention
timeFrame: 60 days
Secondary outcomes:
measure: Albumin After Intervention
timeFrame: 60 days
measure: Glucose After Intervention
timeFrame: 60 days
measure: Total Cholesterol After Intervention
timeFrame: 60 days
measure: Triglyceride After Intervention
timeFrame: 60 days
Other outcomes:
Locations:
Study officials:
affiliation: Office of Human Research, Taipei Medical University
name: Chih-Han Lin, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.