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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: White sweet potato formula; Dietary Supplement: Commercial diabetic formula

• Registration Number: NCT02711839
• Lead Sponsor: Taipei Medical University

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.

Study Timeline

• Status Verified: 2015-05
• Study Start: 2015-08
• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2016-03-13
• Study First Posted: 2016-03-17
• Primary Completion: 2016-11
• Study Completion: 2016-12
• Results First Submitted: 2018-01-24
• Results First Submitted QC: 2019-04-09
• Last Update Submitted: 2019-04-09
• Results First Posted: 2019-07-01
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	White sweet potato formula	White sweet potato formula
Control Group	Commercial diabetic formula	Commercial diabetic formula

Primary Outcome Measures

Name	Time	Method
HbA1c After Intervention	60 days	HbA1c value after 60 days intervention in both groups

Secondary Outcome Measures

Name	Time	Method
Albumin After Intervention	60 days	Albumin value after 60 days intervention in both groups
Glucose After Intervention	60 days	Glucose value after 60 days intervention in both groups
Total Cholesterol After Intervention	60 days	Total cholesterol value after 60 days intervention in both groups
Triglyceride After Intervention	60 days	Triglyceride value after 60 days intervention in both groups