Curcumin for Type 2 Diabetic Patients

Study Overview
=================
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.

Official Title
-----------------
Antiatherogenic and Antimetabolic Effect of Curcumin in Type 2 Diabetic Patients

Conditions
-----------------
Type 2 Diabetes Mellitus, Cardiovascular Abnormalities

Intervention / Treatment
-----------------
* Drug: curcumin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: curcumin<br>* Curcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day for 12 months<br>* Other names: Manufactured by Government Pharmaceutical Organization, Thailand;|
| Experimental: Curcumin<br> | Drug: curcumin<br>* Curcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day for 12 months<br>* Other names: Manufactured by Government Pharmaceutical Organization, Thailand;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the effectiveness of curcumin on the reduction of blood sugar, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, Metabolic syndrome, cardiovascular risk