Pre-diabetesNCT02285231
Anti-hyperglycemic Effect of Short-term Arginyl-fructose Supplementation in Subjects With Pre-diabetes and Newly Diagnosed Type 2 Diabetes: Randomized, Double-blinded, Placebo-controlled Trial.
A study testing Arginyl-fructose in people with Pre-diabetes, run by Yonsei University.
Trial summary
In this double-blind, placebo-controlled study, subjects with prediabetes and type 2 diabetes were randomly assigned to the placebo control group or the test (Arginyl-fructose: AF) group. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Arginyl-fructose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects are with prediabetes (IFG or IGT) or newly diagnosed type 2 DM (T2DM) no taking medicine. IFG was defined as fasting glucose between 100 and 125 mg/dL and IGT was defined as 2-h OGTTs glucose levels 140-199 mg/dL. Newly diagnosed type 2 diabetes was defined as fasting glucose ≥126 mg/dL or 2-h OGTTs level ≥ 200 mg/dL.
Who cannot join
- Exclusion criteria included 1) glucose lowering medications or insulin injections; 2) abnormal liver or renal function; 3) chronic stomach and intestines disease; 4) chronic alcoholism; 5) pregnancy or intending to become pregnant during time of study. 6) complications; 7) an occupation that could be dangerous if hypoglycemia should occur.
About this study
In this double-blind, placebo-controlled study, subjects with prediabetes and type 2 diabetes were randomly assigned to the placebo control group or the test (Arginyl-fructose: AF) group. We determined fasting serum levels of glucose, hemoglobin A1c (HbA1c), insulin, and free fatty acids (FFAs), were measured by 2-h oral glucose tolerance tests (OGTTs) at baseline and after the 6-week intervention.
- Conditions
- Pre-diabetes
- Being tested
- Arginyl-fructose, Placebo
- Keywords
- Anti-hyperglycemic effect
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arginyl-fructoseDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| TEST | Experimental | Arginyl-fructose Supplementation Receives: Dietary Supplement: Arginyl-fructose |
| Placebo | Experimental | Placebo Supplementation Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-h oral glucose tolerance tests (OGTTs
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startNov 2013
- Primary completionFeb 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Ho Lee, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285231
- Sponsor's protocol ID
- 201406-BR-171-04
- Status last verified
- Nov 2014
- First submitted
- 4 Nov 2014
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park SE, Kim OH, Kwak JH, Lee KH, Kwon YI, Chung KH, Lee JH. Antihyperglycemic effect of short-term arginyl-fructose supplementation in subjects with prediabetes and newly diagnosed type 2 diabetes: randomized, double-blinded, placebo-controlled trial. Trials. 2015 Nov 14;16:521. doi: 10.1186/s13063-015-1036-z.
PubMed 26578409
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-hyperglycemic Effect of Short-term Arginyl-fructose Supplementation in Subjects With Pre-diabetes and Newly Diagnosed Type 2 Diabetes: Randomized, Double-blinded, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT02285231
- Acronym / sponsor ID
- 201406-BR-171-04
- Conditions
- Pre-diabetes
- Keywords
- Anti-hyperglycemic effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this double-blind, placebo-controlled study, subjects with prediabetes and type 2 diabetes were randomly assigned to the placebo control group or the test (Arginyl-fructose: AF) group. We determined fasting serum levels of glucose, hemoglobin A1c (HbA1c), insulin, and free fatty acids (FFAs), were measured by 2-h oral glucose tolerance tests (OGTTs) at baseline and after the 6-week intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEST | Experimental | Dietary Supplement: Arginyl-fructoseArginyl-fructose Supplementation |
| Placebo | Experimental | Dietary Supplement: PlaceboPlacebo Supplementation |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All subjects are with prediabetes (IFG or IGT) or newly diagnosed type 2 DM (T2DM) no taking medicine. IFG was defined as fasting glucose between 100 and 125 mg/dL and IGT was defined as 2-h OGTTs glucose levels 140-199 mg/dL. Newly diagnosed type 2 diabetes was defined as fasting glucose ≥126 mg/dL or 2-h OGTTs level ≥ 200 mg/dL.
Key exclusion criteria (1 listed)
- Exclusion criteria included 1) glucose lowering medications or insulin injections; 2) abnormal liver or renal function; 3) chronic stomach and intestines disease; 4) chronic alcoholism; 5) pregnancy or intending to become pregnant during time of study. 6) complications; 7) an occupation that could be dangerous if hypoglycemia should occur.
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 |
|---|---|---|
| Arginyl-fructose | Dietary supplement | TEST |
| Placebo | Dietary supplement | Placebo |
Primary outcome
2-h oral glucose tolerance tests (OGTTs
Time frame: 6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
- Derived from this study: PubMed 26578409Park SE, Kim OH, Kwak JH, Lee KH, Kwon YI, Chung KH, Lee JH. Antihyperglycemic effect of short-term arginyl-fructose supplementation in subjects with prediabetes and newly diagnosed type 2 diabetes: randomized, double-blinded, placebo-controlled trial. Trials. 2015 Nov 14;16:521. doi: 10.1186/s13063-015-1036-z.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Arginyl-fructose in people with Pre-diabetes, run by Yonsei 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 1 inclusion and 1 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 6 Nov 2014. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
2-h oral glucose tolerance tests (OGTTs (time frame: 6 week). 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 NCT02285231, which also lists 1 linked publication.
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 6 Nov 2014.