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NCT Number: NCT02711839

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Commercial diabetic formula

Dietary Supplement

The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation

Other names: diabetic formula

White sweet potato formula

Dietary Supplement

The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation

Other names: White sweet potato

Primary outcomes

  1. HbA1c After Intervention

    Time frame: 60 days

    HbA1c value after 60 days intervention in both groups

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

Office of Human Research, Taipei Medical University

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2016
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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