Curcumin Therapy in Patients With Impaired Glucose Tolerance and Insulin Resistance

Study Overview
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Brief Summary
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The incidence rate of type 2 diabetes in Thai populations is high and increasing every year. Cardiovascular disease is the main complication of this disease, which has been defined as an important cause of death among Diabetic patients. This disease is now becoming a major health problem and causes a great economic loss to the country. Evidence shows that Curcumin, Thai herbal medicine, has the effectiveness of prevention and delay of type 2 diabetes. However, there is no scientific study that aims to prove the efficacy of this herb particularly for prevention and delay the disease in Patients with impaired glucose tolerance (pre-diabetes) and insulin resistance.

Official Title
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Antiatherogenic and Antimetabolic Effect of Curcumin Therapy in the Prevention and Delay of Type 2 Diabetic in Patients With Impaired Glucose Tolerance and Insulin Resistance

Conditions
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Type 2 Diabetes, Pre-diabetes, Insulin Resistance, Cardiovascular Risk

Intervention / Treatment
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* Drug: Curcumin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 35 years or older with an abnormal fasting plasma glucose (100-125 mg/dl) or with insulin resistance (140-199 mg/dl) by using 75 mg of glucose OGTT. Exclusion Criteria: Have been diagnosed with diabetes by the results of FPG >/=126 mg/dl Present with secondary peripheral arterial disease (PAD) Present with cardiovascular diseases such as coronary arterial disease and cerebrovascular disease Receive anticoagulant drugs that have an effect on the measurement of pulse wave velocity (PWV) Receive antihypertensive or lipid-lowering drugs (ARB, ACEI, fenofibrate, atorvastatin, rosuvastatin, fluvastatin) that have an effect on the measurement of C-reactive protein (CRP) Present with kidney failure (serum creatinine > 2.0 mg/dl) or in the process of renal dialysis Present with hepatitis (ALT level >/= 3 times the upper limit) Receive any herbal medications or curcumin Present with high blood sugar from other causes apart from type 2 diabetes such as receiving steroid drugs, cancer or pancreatic cyst Present with infection or inflammation that have effect on the level of CRP Pregnancy or breastfeeding Have a history of gall bladder diseases or removal

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin<br>curcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months | Drug: Curcumin<br>* curcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months<br>* Other names: Curcumin capsules are manufactured by Government Pharmaceutical Organization, Thailand;|
| No Intervention: Placebo<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the efficacy of curcumin on the delay of degenerative beta-cells in pancrease for protection of Type 2 Diabetes in patients with impaired glucose tolerance (Pre-diabetes) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the efficacy of curcumin on the reduction of blood sugar level, lipid profile, insulin resistance status and oxidative stress status in Pre-diabetes patients |  | 12 months |