Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance)Phase 4NCT01964703
Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes
A Phase 4 study testing Rubus occidentalis extract in people with Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance), run by Korea University Anam Hospital.
Trial summary
The purpose of this study is to determine whether Rubus occidentalis extract could improve fasting or postprandial serum glucose levels, and related metabolic markers among patients with prediabetes (impaired fasting glucose and/or impaired glucose tolerance). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance)
- What is being tested?
- Rubus occidentalis extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Oct 2013
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years of age or older
- prediabetes (fasting plasma glucose 100-125mg/dl, and/or post 75g OGTT plasma glucose 140-199mg/dl)
Who cannot join
- pregnant women
- taking anti-hyperglycemic agents within 3 months at the time of enrollment
- history of heart failure, myocardial infarction, cerebral infarction
- uncontrolled hypertension (systolic BP > 160mmHg, or diastolic BP > 100mmHg)
- serum triglyceride level > 500mg/dl
- kidney dysfunction (serum Creatinine > 30% of upper normal limits)
- hepatic dysfunction (AST, ALT > 3 times of upper normal limits)
- taking systemic glucocorticoids within 1 month
About this study
Official title: Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes; A Proof-of-concept, Randomized, Double-blind, Parallel-group Placebo-controlled Study
The purpose of this study is to determine whether Rubus occidentalis extract could improve fasting or postprandial serum glucose levels, and related metabolic markers among patients with prediabetes (impaired fasting glucose and/or impaired glucose tolerance).
- Being tested
- Rubus occidentalis extract
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rubus occidentalis extractDrug
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | Not described |
| Rubus occidentalis extract 900mg | Active comparator | taking Rubus occidentalis extract 900mg/day for 12weeks Receives: Drug: Rubus occidentalis extract |
| Rubus occidentalis extract 1800mg | Active comparator | taking Rubus occidentalis extract 1800mg/day for 12weeks Receives: Drug: Rubus occidentalis extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum glucose (fasting and post 75g oral glucose tolerance test)
Measured: 12 weeks
Secondary outcomes (1)
serum insulin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2013
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 Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sin Gon Kim, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964703
- Sponsor's protocol ID
- ED13024
- Status last verified
- Oct 2013
- First submitted
- 14 Oct 2013
- Last updated
- 17 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
An JH, Kim DL, Lee TB, Kim KJ, Kim SH, Kim NH, Kim HY, Choi DS, Kim SG. Effect of Rubus Occidentalis Extract on Metabolic Parameters in Subjects with Prediabetes: A Proof-of-concept, Randomized, Double-blind, Placebo-controlled Clinical Trial. Phytother Res. 2016 Oct;30(10):1634-1640. doi: 10.1002/ptr.5664. Epub 2016 Jun 9.
PubMed 27279471
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes; A Proof-of-concept, Randomized, Double-blind, Parallel-group Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01964703
- Acronym / sponsor ID
- ED13024
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (actual)
- First posted
- 17 Oct 2013 (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.
The purpose of this study is to determine whether Rubus occidentalis extract could improve fasting or postprandial serum glucose levels, and related metabolic markers among patients with prediabetes (impaired fasting glucose and/or impaired glucose tolerance).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | – |
| Rubus occidentalis extract 900mg | Active comparator | Drug: Rubus occidentalis extracttaking Rubus occidentalis extract 900mg/day for 12weeks |
| Rubus occidentalis extract 1800mg | Active comparator | Drug: Rubus occidentalis extracttaking Rubus occidentalis extract 1800mg/day for 12weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 19 years of age or older
- prediabetes (fasting plasma glucose 100-125mg/dl, and/or post 75g OGTT plasma glucose 140-199mg/dl)
Key exclusion criteria (8 listed)
- pregnant women
- taking anti-hyperglycemic agents within 3 months at the time of enrollment
- history of heart failure, myocardial infarction, cerebral infarction
- uncontrolled hypertension (systolic BP > 160mmHg, or diastolic BP > 100mmHg)
- serum triglyceride level > 500mg/dl
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 |
|---|---|---|
| Rubus occidentalis extract | Drug | Rubus occidentalis extract 1800mg, Rubus occidentalis extract 900mg |
Primary outcome
serum glucose (fasting and post 75g oral glucose tolerance test)
Time frame: 12 weeks
1 secondary outcome
serum insulin
Time frame: 12 weeks
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 17 Oct 2013.
- Derived from this study: PubMed 27279471An JH, Kim DL, Lee TB, Kim KJ, Kim SH, Kim NH, Kim HY, Choi DS, Kim SG. Effect of Rubus Occidentalis Extract on Metabolic Parameters in Subjects with Prediabetes: A Proof-of-concept, Randomized, Double-blind, Placebo-controlled Clinical Trial. Phytother Res. 2016 Oct;30(10):1634-1640. doi: 10.1002/ptr.5664. Epub 2016 Jun 9.
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 Phase 4 study testing Rubus occidentalis extract in people with Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance), run by Korea University Anam Hospital.
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 8 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 17 Oct 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
serum glucose (fasting and post 75g oral glucose tolerance test) (time frame: 12 weeks). 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 NCT01964703, 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 17 Oct 2013.