Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments commercial diabetic formula, white sweet potato formula
Phase phase 2/phase 3
Sponsor Taipei Medical University
Start date August 2015
End date November 2016
Trial size 50 participants
Trial identifier NCT02711839, 201505027

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Placebo Comparator)
Commercial diabetic formula
commercial diabetic formula diabetic formula
The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
(Experimental)
White sweet potato formula
white sweet potato formula White sweet potato
The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation

Primary Outcomes

Measure
Change From Baseline in HbA1c
time frame: 60 days

Secondary Outcomes

Measure
Change From Baseline in Albumin
time frame: 60 days
Change From Baseline in Glucose
time frame: 60 days
Change From Baseline in Total Cholesterol
time frame: 60 days
Change From Baseline in Triglyceride
time frame: 60 days

Eligibility Criteria

Male or female participants from 30 years up to 80 years old.

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).

Additional Information

Official title Office of Human Research, Taipei Medical University
Principal investigator Chih-Han Lin, MS
Description All subjects will be evaluated the blood sugar and clinical nutrition assessment such as postural measurement, urine test and blood biomarker examination.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Taipei Medical University.