Type 2 Diabetes MellitusPhase 4NCT01052597
Curcumin for Type 2 Diabetic Patients
A Phase 4 study testing curcumin in people with Type 2 Diabetes Mellitus and Cardiovascular Abnormalities, run by Srinakharinwirot University at 1 site in Thailand.
Trial summary
There are evidence that there is an association between insulin resistance and prolonged hyperinsulinemia or hyperglycemia in Type 2 diabetic patients. This will trigger oxidative stress system via reactive oxygen species (ROS) and lead to a high level of Nitric oxide. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Cardiovascular Abnormalities
- What is being tested?
- curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2009to Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic patients aged 35 years or older and did not use insulin during the first 5 years of treatment after being diagnosed (with or without symptoms listed in the following inclusion criteria)
- Patient with hyperlipidemia (Cholesterol ≥ 200 mg/dl, TG ≥ 150 mg/dl, LDL ≥ 100 mg/dl and HDL ≥ 35 mg/dl)
- Patient with hypertension (Blood pressure ≥ 130/85 mmHg or take hypertensive drugs)
- Obesity (BMI ≥ 25)
Who cannot join
- Current diagnosis of secondary peripheral arterial disease (PAD) (except listed in the inclusion criteria item 1-4)
- Current diagnosis of cardiovascular disease, i.e., coronary arterial disease and cerebrovascular disease
- Current diagnosis of end stage renal function with serum creatinine > 2.0 mg/dl or on renal dialysis
- Current diagnosis of cirrhosis with ALT ≥ 3 times of normal range
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, +6637-39-5085, somlukc@swu.ac.th
Somlak Chuengsamarn, Medical Doctor
About this study
Official title: Antiatherogenic and Antimetabolic Effect of Curcumin in Type 2 Diabetic Patients
There are evidence that there is an association between insulin resistance and prolonged hyperinsulinemia or hyperglycemia in Type 2 diabetic patients. This will trigger oxidative stress system via reactive oxygen species (ROS) and lead to a high level of Nitric oxide. This can contribute to a significant change in blood vessel and could end up with the complications from cardiovascular disease and increased mortality rate of type 2 diabetic patients. The purpose of the present study was to examine the effectiveness of the curcumin in type 2 diabetic patients on the reduction of atherosclerosis events by examining pulse-wave velocity (PWV) and plasma high-sensitivity C-reactive protein (CRP) test and on blood sugar lowering, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance.
- Being tested
- curcumin
- Keywords
- Type 2 diabetes, Metabolic syndrome, cardiovascular risk
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Abnormalities, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcuminDrug
Also called Manufactured by Government Pharmaceutical Organization, Thailand
Curcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: curcumin |
| Curcumin | Experimental | Not described Receives: Drug: curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients
Measured: 12 months
Secondary outcomes (1)
To examine the effectiveness of curcumin on the reduction of blood sugar, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance
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 startJul 2009
- Primary completionFeb 2010 (estimated)
- Study completionMar 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 Diabetes MellitusStudies 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
- 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
- NCT01052597
- Sponsor's protocol ID
- SWUEC30/2550
- Status last verified
- Aug 2007
- First submitted
- 19 Jan 2010
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Chuengsamarn S, Rattanamongkolgul S, Phonrat B, Tungtrongchitr R, Jirawatnotai S. Reduction of atherogenic risk in patients with type 2 diabetes by curcuminoid extract: a randomized controlled trial. J Nutr Biochem. 2014 Feb;25(2):144-50. doi: 10.1016/j.jnutbio.2013.09.013. Epub 2013 Nov 6.
PubMed 24445038
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 in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01052597
- Acronym / sponsor ID
- SWUEC30/2550
- Keywords
- Type 2 diabetes, Metabolic syndrome, 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
- Jul 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Mar 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.
There are evidence that there is an association between insulin resistance and prolonged hyperinsulinemia or hyperglycemia in Type 2 diabetic patients. This will trigger oxidative stress system via reactive oxygen species (ROS) and lead to a high level of Nitric oxide. This can contribute to a significant change in blood vessel and could end up with the complications from cardiovascular disease and increased mortality rate of type 2 diabetic patients. The purpose of the present study was to examine the effectiveness of the curcumin in type 2 diabetic patients on the reduction of atherosclerosis events by examining pulse-wave velocity (PWV) and plasma high-sensitivity C-reactive protein (CRP) test and on blood sugar lowering, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: curcumin |
| Curcumin | Experimental | Drug: curcumin |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetic patients aged 35 years or older and did not use insulin during the first 5 years of treatment after being diagnosed (with or without symptoms listed in the following inclusion criteria)
- Patient with hyperlipidemia (Cholesterol ≥ 200 mg/dl, TG ≥ 150 mg/dl, LDL ≥ 100 mg/dl and HDL ≥ 35 mg/dl)
- Patient with hypertension (Blood pressure ≥ 130/85 mmHg or take hypertensive drugs)
- Obesity (BMI ≥ 25)
Key exclusion criteria (4 listed)
- Current diagnosis of secondary peripheral arterial disease (PAD) (except listed in the inclusion criteria item 1-4)
- Current diagnosis of cardiovascular disease, i.e., coronary arterial disease and cerebrovascular disease
- Current diagnosis of end stage renal function with serum creatinine > 2.0 mg/dl or on renal dialysis
- Current diagnosis of cirrhosis with ALT ≥ 3 times of normal range
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: Manufactured by Government Pharmaceutical Organization, ThailandCurcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day for 12 months | Drug | Curcumin, Placebo |
Primary outcome
to determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients
Time frame: 12 months
1 secondary outcome
To examine the effectiveness of curcumin on the reduction of blood sugar, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance
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 24445038Chuengsamarn S, Rattanamongkolgul S, Phonrat B, Tungtrongchitr R, Jirawatnotai S. Reduction of atherogenic risk in patients with type 2 diabetes by curcuminoid extract: a randomized controlled trial. J Nutr Biochem. 2014 Feb;25(2):144-50. doi: 10.1016/j.jnutbio.2013.09.013. Epub 2013 Nov 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 Mellitus and Cardiovascular Abnormalities, 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 4 inclusion and 4 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. 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?
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 (+6637-39-5085, 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 determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients (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 NCT01052597, 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; AzTrials last refreshed its copy on 30 Oct 2026.