Type 2 DiabetesNCT02711839
Evaluation of White Sweet Potato Tube Feeding Formula on Type 2 Diabetic Residents in Long-term Care Institutions
A study testing Commercial diabetic formula and White sweet potato formula in people with Type 2 Diabetes, run by Taipei Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Commercial diabetic formula and White sweet potato formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Long-term stability nasogastric or gastrostomy-fed person.
- The physician diagnosed as diabetic and regular use of hypoglycemic drugs.
Who cannot join
- 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).
About this study
Official title: Office of Human Research, Taipei Medical University
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.
Read the detailed description
All subjects will be evaluated the blood sugar and clinical nutrition assessment such as postural measurement, urine test and blood biomarker examination.
- Conditions
- Type 2 Diabetes
- Being tested
- Commercial diabetic formula, White sweet potato formula
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial diabetic formulaDietary supplement
Also called diabetic formula
The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
White sweet potato formulaDietary supplement
Also called White sweet potato
The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Commercial diabetic formula Receives: Dietary Supplement: Commercial diabetic formula |
| Treatment Group | Experimental | White sweet potato formula Receives: Dietary Supplement: White sweet potato formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c After Intervention
HbA1c value after 60 days intervention in both groups
Measured: 60 days
Secondary outcomes (4)
Albumin After Intervention
Albumin value after 60 days intervention in both groups
Measured: 60 days
Glucose After Intervention
Glucose value after 60 days intervention in both groups
Measured: 60 days
Total Cholesterol After Intervention
Total cholesterol value after 60 days intervention in both groups
Measured: 60 days
Triglyceride After Intervention
Triglyceride value after 60 days intervention in both groups
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startAug 2015
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih-Han Lin, MS, Principal investigator, Office of Human Research, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711839
- Sponsor's protocol ID
- 201505027
- Status last verified
- May 2015
- First submitted
- 17 Nov 2015
- Last updated
- 1 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24000051Chen 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.
PubMed 31636690
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Office of Human Research, Taipei Medical University
- ClinicalTrials.gov ID
- NCT02711839
- Acronym / sponsor ID
- 201505027
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Posted 1 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Dietary Supplement: Commercial diabetic formulaCommercial diabetic formula |
| Treatment Group | Experimental | Dietary Supplement: White sweet potato formulaWhite sweet potato formula |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Long-term stability nasogastric or gastrostomy-fed person.
- The physician diagnosed as diabetic and regular use of hypoglycemic drugs.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercial diabetic formulaAlso: diabetic formulaThe formula were supplied 1500~1800 kcal daily depend on the patient's individual situation | Dietary supplement | Control Group |
| White sweet potato formulaAlso: White sweet potatoThe formula were supplied 1500~1800 kcal daily depend on the patient's individual situation | Dietary supplement | Treatment Group |
Primary outcome
HbA1c After Intervention
Time frame: 60 days
HbA1c value after 60 days intervention in both groups
4 secondary outcomes
Albumin After Intervention
Time frame: 60 days
Glucose After Intervention
Time frame: 60 days
Total Cholesterol After Intervention
Time frame: 60 days
Triglyceride After Intervention
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24000051Ooi 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.
- Derived from this study: PubMed 31636690Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih-Han Lin, MS principal investigator
Office of Human Research, Taipei Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Commercial diabetic formula and White sweet potato formula in people with Type 2 Diabetes, run by Taipei Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c After Intervention (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02711839, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019.