Type 2 DiabetesPhase 4NCT01052025
Curcumin Therapy in Patients With Impaired Glucose Tolerance and Insulin Resistance
A Phase 4 study testing Curcumin in people with Type 2 Diabetes and Pre-diabetes, run by Srinakharinwirot University at 1 site in Thailand.
Trial summary
The incidence rate of type 2 diabetes in Thai populations is high and increasing every year. Cardiovascular disease is the main complication of this disease, which has been defined as an important cause of death among Diabetic patients. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Pre-diabetes, Insulin Resistance
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2009to Apr 2010
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 35 years or older with an abnormal fasting plasma glucose (100-125 mg/dl) or with insulin resistance (140-199 mg/dl) by using 75 mg of glucose OGTT.
Who cannot join
- Have been diagnosed with diabetes by the results of FPG >/=126 mg/dl
- Present with secondary peripheral arterial disease (PAD)
- Present with cardiovascular diseases such as coronary arterial disease and cerebrovascular disease
- Receive anticoagulant drugs that have an effect on the measurement of pulse wave velocity (PWV)
- Receive antihypertensive or lipid-lowering drugs (ARB, ACEI, fenofibrate, atorvastatin, rosuvastatin, fluvastatin) that have an effect on the measurement of C-reactive protein (CRP)
- Present with kidney failure (serum creatinine > 2.0 mg/dl) or in the process of renal dialysis
Show all 12Show fewer
- Present with hepatitis (ALT level >/= 3 times the upper limit)
- Receive any herbal medications or curcumin
- Present with high blood sugar from other causes apart from type 2 diabetes such as receiving steroid drugs, cancer or pancreatic cyst
- Present with infection or inflammation that have effect on the level of CRP
- Pregnancy or breastfeeding
- Have a history of gall bladder diseases or removal
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
HRH Princess Maha Chakri Sirindhorn Medical Center
Ongkarak, Nakornnayok, 26120
Somlak Chuengsamarn, Medical Doctor, +663739-5085 ext. 11001, somlukc@swu.ac.th
Somlak Chuengsamarn, Medical Doctor
About this study
Official title: Antiatherogenic and Antimetabolic Effect of Curcumin Therapy in the Prevention and Delay of Type 2 Diabetic in Patients With Impaired Glucose Tolerance and Insulin Resistance
The incidence rate of type 2 diabetes in Thai populations is high and increasing every year. Cardiovascular disease is the main complication of this disease, which has been defined as an important cause of death among Diabetic patients. This disease is now becoming a major health problem and causes a great economic loss to the country. Evidence shows that Curcumin, Thai herbal medicine, has the effectiveness of prevention and delay of type 2 diabetes. However, there is no scientific study that aims to prove the efficacy of this herb particularly for prevention and delay the disease in Patients with impaired glucose tolerance (pre-diabetes) and insulin resistance.
- Conditions
- Type 2 Diabetes, Pre-diabetes, Insulin Resistance, Cardiovascular Risk
- Being tested
- Curcumin
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Also called Curcumin capsules are manufactured by Government Pharmaceutical Organization, Thailand
curcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Curcumin | Experimental | curcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months Receives: Drug: Curcumin |
| Placebo | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the efficacy of curcumin on the delay of degenerative beta-cells in pancrease for protection of Type 2 Diabetes in patients with impaired glucose tolerance (Pre-diabetes)
Measured: 12 months
Secondary outcomes (1)
To examine the efficacy of curcumin on the reduction of blood sugar level, lipid profile, insulin resistance status and oxidative stress status in Pre-diabetes patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startAug 2009
- Primary completionMar 2010 (estimated)
- Study completionApr 2010 (estimated)
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 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Srinakharinwirot University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Investigators
- Somlak Chuengsamarn, Medical Doctor, Principal investigator, Srinakarinwirot University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052025
- Sponsor's protocol ID
- SWUEC9/2552
- Status last verified
- Mar 2009
- First submitted
- 19 Jan 2010
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Chuengsamarn S, Rattanamongkolgul S, Luechapudiporn R, Phisalaphong C, Jirawatnotai S. Curcumin extract for prevention of type 2 diabetes. Diabetes Care. 2012 Nov;35(11):2121-7. doi: 10.2337/dc12-0116. Epub 2012 Jul 6.
PubMed 22773702
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiatherogenic and Antimetabolic Effect of Curcumin Therapy in the Prevention and Delay of Type 2 Diabetic in Patients With Impaired Glucose Tolerance and Insulin Resistance
- ClinicalTrials.gov ID
- NCT01052025
- Acronym / sponsor ID
- SWUEC9/2552
- Conditions
- Type 2 Diabetes, Pre-diabetes, Insulin Resistance, Cardiovascular Risk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Srinakharinwirot UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Study start
- Aug 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 20 Jan 2010 (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 incidence rate of type 2 diabetes in Thai populations is high and increasing every year. Cardiovascular disease is the main complication of this disease, which has been defined as an important cause of death among Diabetic patients. This disease is now becoming a major health problem and causes a great economic loss to the country. Evidence shows that Curcumin, Thai herbal medicine, has the effectiveness of prevention and delay of type 2 diabetes. However, there is no scientific study that aims to prove the efficacy of this herb particularly for prevention and delay the disease in Patients with impaired glucose tolerance (pre-diabetes) and insulin resistance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcumin | Experimental | Drug: Curcumincurcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months |
| Placebo | No intervention | – |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 35 years or older with an abnormal fasting plasma glucose (100-125 mg/dl) or with insulin resistance (140-199 mg/dl) by using 75 mg of glucose OGTT.
Key exclusion criteria (12 listed)
- Have been diagnosed with diabetes by the results of FPG >/=126 mg/dl
- Present with secondary peripheral arterial disease (PAD)
- Present with cardiovascular diseases such as coronary arterial disease and cerebrovascular disease
- Receive anticoagulant drugs that have an effect on the measurement of pulse wave velocity (PWV)
- Receive antihypertensive or lipid-lowering drugs (ARB, ACEI, fenofibrate, atorvastatin, rosuvastatin, fluvastatin) that have an effect on the measurement of C-reactive protein (CRP)
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 |
|---|---|---|
| CurcuminAlso: Curcumin capsules are manufactured by Government Pharmaceutical Organization, Thailandcurcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months | Drug | Curcumin |
Primary outcome
To examine the efficacy of curcumin on the delay of degenerative beta-cells in pancrease for protection of Type 2 Diabetes in patients with impaired glucose tolerance (Pre-diabetes)
Time frame: 12 months
1 secondary outcome
To examine the efficacy of curcumin on the reduction of blood sugar level, lipid profile, insulin resistance status and oxidative stress status in Pre-diabetes patients
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
- Derived from this study: PubMed 22773702Chuengsamarn S, Rattanamongkolgul S, Luechapudiporn R, Phisalaphong C, Jirawatnotai S. Curcumin extract for prevention of type 2 diabetes. Diabetes Care. 2012 Nov;35(11):2121-7. doi: 10.2337/dc12-0116. Epub 2012 Jul 6.
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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.
Somlak Chuengsamarn, Medical Doctor principal investigator
Srinakarinwirot University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Curcumin in people with Type 2 Diabetes and Pre-diabetes, run by Srinakharinwirot University at 1 site in Thailand.
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 12 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: status not confirmed, as of the sponsor's last update on 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Somlak Chuengsamarn, Medical Doctor (+663739-5085 ext. 11001, somlukc@swu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the efficacy of curcumin on the delay of degenerative beta-cells in pancrease for protection of Type 2 Diabetes in patients with impaired glucose tolerance (Pre-diabetes) (time frame: 12 months). 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 NCT01052025, 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 20 Jan 2010.