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

Type 2 Diabetes Clinical Trial

Official title:

Office of Human Research, Taipei Medical University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711839
• Other study ID #: 201505027
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2015
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Dietary Supplement:
• Commercial diabetic formula
The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
• White sweet potato formula
The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

References & Publications (1)

Ooi CP, Loke SC. Sweet potato for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2013 Sep 3;(9):CD009128. doi: 10.1002/14651858.CD009128.pub3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c After Intervention	HbA1c value after 60 days intervention in both groups	60 days
Secondary	Albumin After Intervention	Albumin value after 60 days intervention in both groups	60 days
Secondary	Glucose After Intervention	Glucose value after 60 days intervention in both groups	60 days
Secondary	Total Cholesterol After Intervention	Total cholesterol value after 60 days intervention in both groups	60 days
Secondary	Triglyceride After Intervention	Triglyceride value after 60 days intervention in both groups	60 days