Curcumin for Type 2 Diabetic Patients

Antiatherogenic and Antimetabolic Effect of Curcumin in Type 2 Diabetic Patients

Sponsors

Lead Sponsor: Srinakharinwirot University

Collaborator: Ministry of Health, Thailand

Source Srinakharinwirot University
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.

Overall Status Unknown status
Start Date 2009-07-01
Completion Date 2010-03-01
Primary Completion Date 2010-02-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
to determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients 12 months
Secondary Outcome
Measure Time Frame
To examine the effectiveness of curcumin on the reduction of blood sugar, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance 12 months
Enrollment 200
Condition
Intervention

Intervention Type: Drug

Intervention Name: curcumin

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

Other Name: Manufactured by Government Pharmaceutical Organization, Thailand

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

35 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Somlak Chuengsamarn, Medical Doctor Principal Investigator Srinakarinwirot University
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Status: Contact: Investigator: HRH Princess Maha Chakri Sirindhorn Medical Center Somlak Chuengsamarn, Medical Doctor +6637-39-5085 [email protected] Somlak Chuengsamarn, Medical Doctor Principal Investigator
Location Countries

Thailand

Verification Date

2007-08-01

Responsible Party

Name Title: Assist.Prof. Somlak Chuengsamarn

Organization: Department of Internal Medicines, Faculty of Medicine, Srinakarinwirot University

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Placebo

Type: Placebo Comparator

Label: Curcumin

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

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