NCT02711839

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 1, 2019

Completed
Last Updated

July 1, 2019

Status Verified

May 1, 2015

Enrollment Period

1.3 years

First QC Date

November 17, 2015

Results QC Date

January 24, 2018

Last Update Submit

April 9, 2019

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c After Intervention

    HbA1c value after 60 days intervention in both groups

    60 days

Secondary Outcomes (4)

  • Albumin After Intervention

    60 days

  • Glucose After Intervention

    60 days

  • Total Cholesterol After Intervention

    60 days

  • Triglyceride After Intervention

    60 days

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Commercial diabetic formula

Dietary Supplement: Commercial diabetic formula

Treatment Group

EXPERIMENTAL

White sweet potato formula

Dietary Supplement: White sweet potato formula

Interventions

Commercial diabetic formulaDIETARY_SUPPLEMENT

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

Also known as: diabetic formula
Control Group
White sweet potato formulaDIETARY_SUPPLEMENT

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

Also known as: White sweet potato
Treatment Group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Long-term stability nasogastric or gastrostomy-fed person.
  • The physician diagnosed as diabetic and regular use of hypoglycemic drugs.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

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

    PMID: 24000051BACKGROUND

  • Chen CM, Shih CK, Su YJ, Cheang KU, Lo SF, Li SC. Evaluation of white sweet potato tube-feeding formula in elderly diabetic patients: a randomized controlled trial. Nutr Metab (Lond). 2019 Oct 16;16:70. doi: 10.1186/s12986-019-0398-8. eCollection 2019.

    PMID: 31636690DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

Small experimental sample size and trial duration that may cause impose an obstacle in the detection of significant changes of the study measure.

Results Point of Contact

Title
Dr. Sing-Chung Li
Organization
Taipei Medical University
sinchung@tmu.edu.tw
886-2-27361661

Study Officials

  • Chih-Han Lin, MS

    Office of Human Research, Taipei Medical University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2015

First Posted

March 17, 2016

Study Start

August 1, 2015

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

July 1, 2019

Results First Posted

July 1, 2019

Record last verified: 2015-05

Data Sharing

IPD Sharing
Will not share