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

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ClinicalTrials.gov Identifier: NCT02711839
Recruitment Status : Completed
First Posted : March 17, 2016
Results First Posted : July 1, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: Commercial diabetic formula Dietary Supplement: White sweet potato formula Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Office of Human Research, Taipei Medical University
Study Start Date : August 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control Group
Commercial diabetic formula
Dietary Supplement: Commercial diabetic formula
The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
Other Name: diabetic formula

Experimental: Treatment Group
White sweet potato formula
Dietary Supplement: White sweet potato formula
The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
Other Name: White sweet potato




Primary Outcome Measures :
  1. HbA1c After Intervention [ Time Frame: 60 days ]
    HbA1c value after 60 days intervention in both groups


Secondary Outcome Measures :
  1. Albumin After Intervention [ Time Frame: 60 days ]
    Albumin value after 60 days intervention in both groups

  2. Glucose After Intervention [ Time Frame: 60 days ]
    Glucose value after 60 days intervention in both groups

  3. Total Cholesterol After Intervention [ Time Frame: 60 days ]
    Total cholesterol value after 60 days intervention in both groups

  4. Triglyceride After Intervention [ Time Frame: 60 days ]
    Triglyceride value after 60 days intervention in both groups



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711839


Sponsors and Collaborators
Taipei Medical University
Investigators
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Principal Investigator: Chih-Han Lin, MS Office of Human Research, Taipei Medical University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Taipei Medical University
ClinicalTrials.gov Identifier: NCT02711839    
Other Study ID Numbers: 201505027
First Posted: March 17, 2016    Key Record Dates
Results First Posted: July 1, 2019
Last Update Posted: July 1, 2019
Last Verified: May 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No