Curcumin for Type 2 Diabetic Patients

Sponsor

Srinakharinwirot University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01052597

Collaborator

Ministry of Health, Thailand (Other)

200

Enrollment

Location

Arms

Duration (Months)

25.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Cardiovascular Abnormalities	Drug: curcumin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Antiatherogenic and Antimetabolic Effect of Curcumin in Type 2 Diabetic Patients

Study Start Date :

Jul 1, 2009

Anticipated Primary Completion Date :

Feb 1, 2010

Anticipated Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: curcumin Curcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day for 12 months Other Names: Manufactured by Government Pharmaceutical Organization, Thailand
Experimental: Curcumin	Drug: curcumin Curcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day for 12 months Other Names: Manufactured by Government Pharmaceutical Organization, Thailand

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Drug: curcumin

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

Other Names:

Manufactured by Government Pharmaceutical Organization, Thailand

Experimental: Curcumin

Drug: curcumin

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

Other Names:

Manufactured by Government Pharmaceutical Organization, Thailand

Outcome Measures

Primary Outcome Measures

to determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients [12 months]

Secondary Outcome Measures

To examine the effectiveness of curcumin on the reduction of blood sugar, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)

Exclusion Criteria:

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