Curcumin for Type 2 Diabetic Patients

NCT ID: NCT01052597

Last Updated: 2010-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Cardiovascular Abnormalities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

curcumin

Intervention Type DRUG

Curcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day for 12 months

Curcumin

Group Type EXPERIMENTAL

curcumin

Intervention Type DRUG

Curcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day for 12 months

Interventions

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curcumin

Curcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day for 12 months

Intervention Type DRUG

Other Intervention Names

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Manufactured by Government Pharmaceutical Organization, Thailand

Eligibility Criteria

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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)

* 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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Thailand

OTHER_GOV

Sponsor Role collaborator

Srinakharinwirot University

OTHER

Sponsor Role lead

Responsible Party

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Department of Internal Medicines, Faculty of Medicine, Srinakarinwirot University

Principal Investigators

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Somlak Chuengsamarn, Medical Doctor

Role: PRINCIPAL_INVESTIGATOR

Srinakarinwirot University

Locations

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HRH Princess Maha Chakri Sirindhorn Medical Center

Ongkarak, Nakornnayok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Somlak Chuengsamarn, Medical Doctor

Role: CONTACT

+6637-39-5085

Facility Contacts

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Somlak Chuengsamarn, Medical Doctor

Role: primary

+6637-39-5085

References

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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.

Reference Type DERIVED
PMID: 24445038 (View on PubMed)

Other Identifiers

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SWUEC30/2550

Identifier Type: -

Identifier Source: org_study_id

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