Type 2 DiabetesPhase 3NCT01360567
The Effect of Green Tea Extract on Type 2 Diabetes With Hyperlipidemia
A Phase 3 study testing Green tea extract in people with Type 2 Diabetes and Hyperlipidemia, run by Taipei City Hospital at 2 sites in Taiwan.
Trial summary
The aim of the study is to examine whether the extract of green tea is effective on type 2 diabetes and hyperlipidemia. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Type 2 Diabetes, Hyperlipidemia
- What is being tested?
- Green tea extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 2 sitesTaiwan
- Study dates
- May 2011to Dec 2012
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20--69 years old
- Type 2 diabetes for > one year
- TG >= 150 mg/dl or LDL >= 100 mg/dl
Who cannot join
- GPT > 80 mg/dl
- Creatinine > 1.8 mg/dl
- Pregnancy
- AMI
- Stroke
- Operational or any not suitable patients diagnosis physician in charge
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Taipei City Hospital, Taipei, Taiwan
The aim of the study is to examine whether the extract of green tea is effective on type 2 diabetes and hyperlipidemia.
Read the detailed description
Percent change Homa insulin resistance, cholesterol and triglycerol.
- Conditions
- Type 2 Diabetes, Hyperlipidemia
- Being tested
- Green tea extract, Placebo
- Keywords
- green tea, EGCG, type 2 diabetes, hyperlipidemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green tea extractDietary supplement
Also called EGCG: Green tea extract
500 mg . one capsule of green tea extract, 3 times per day
PlaceboDietary supplement
500 mg . one capsule of placebo, 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| B formula | Placebo comparator | placebo Receives: Dietary Supplement: Placebo |
| A formula | Experimental | Green tea extract Receives: Dietary Supplement: Green tea extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change of HOMA insulin resistance and TG
Measured: 16 weeks
Secondary outcomes (1)
Percent change of HbA1C and Cholesterol
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Collaborators
- National Yang Ming Chiao Tung University
- Responsible party
- Principal investigator, Chung-Hua Hsu, Taipei City Hospital
- Investigators
- Chung-Hua Hsu, MD, PhD, Principal investigator, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360567
- Sponsor's protocol ID
- 100002-63-020
- Other IDs
- TCH-971103, TCHIRB-971103
- Status last verified
- Apr 2013
- First submitted
- 20 May 2011
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12.
PubMed 18468736Liu CY, Huang CJ, Huang LH, Chen IJ, Chiu JP, Hsu CH. Effects of green tea extract on insulin resistance and glucagon-like peptide 1 in patients with type 2 diabetes and lipid abnormalities: a randomized, double-blinded, and placebo-controlled trial. PLoS One. 2014 Mar 10;9(3):e91163. doi: 10.1371/journal.pone.0091163. eCollection 2014.
PubMed 24614112
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taipei City Hospital, Taipei, Taiwan
- ClinicalTrials.gov ID
- NCT01360567
- Acronym / sponsor ID
- 100002-63-020
- Conditions
- Type 2 Diabetes, Hyperlipidemia
- Keywords
- green tea, EGCG, type 2 diabetes, hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Collaborators
- National Yang Ming Chiao Tung University
- Study start
- May 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 May 2011 (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 aim of the study is to examine whether the extract of green tea is effective on type 2 diabetes and hyperlipidemia.
Detailed description
Percent change Homa insulin resistance, cholesterol and triglycerol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B formula | Placebo comparator | Dietary Supplement: Placeboplacebo |
| A formula | Experimental | Dietary Supplement: Green tea extractGreen tea extract |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 20--69 years old
- Type 2 diabetes for > one year
- TG >= 150 mg/dl or LDL >= 100 mg/dl
Key exclusion criteria (6 listed)
- GPT > 80 mg/dl
- Creatinine > 1.8 mg/dl
- Pregnancy
- AMI
- Stroke
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 |
|---|---|---|
| Green tea extractAlso: EGCG: Green tea extract500 mg . one capsule of green tea extract, 3 times per day | Dietary supplement | A formula |
| Placebo500 mg . one capsule of placebo, 3 times per day | Dietary supplement | B formula |
Primary outcome
Percent change of HOMA insulin resistance and TG
Time frame: 16 weeks
1 secondary outcome
Percent change of HbA1C and Cholesterol
Time frame: 16 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 30 Apr 2013.
- Background: PubMed 18468736Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12.
- Derived from this study: PubMed 24614112Liu CY, Huang CJ, Huang LH, Chen IJ, Chiu JP, Hsu CH. Effects of green tea extract on insulin resistance and glucagon-like peptide 1 in patients with type 2 diabetes and lipid abnormalities: a randomized, double-blinded, and placebo-controlled trial. PLoS One. 2014 Mar 10;9(3):e91163. doi: 10.1371/journal.pone.0091163. eCollection 2014.
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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.
Chung-Hua Hsu, MD, PhD principal investigator
Taipei City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Green tea extract in people with Type 2 Diabetes and Hyperlipidemia, run by Taipei City Hospital at 2 sites in Taiwan.
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 3 inclusion and 6 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 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percent change of HOMA insulin resistance and TG (time frame: 16 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 NCT01360567, 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 30 Apr 2013.