Curcumin Therapy in Patients With Impaired Glucose Tolerance and Insulin Resistance

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

Sponsors

Lead Sponsor: Srinakharinwirot University

Collaborator: Ministry of Health, Thailand

Source Srinakharinwirot University
Brief Summary

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.

Overall Status Unknown status
Start Date 2009-08-01
Completion Date 2010-04-01
Primary Completion Date 2010-03-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure 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
Measure 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
Enrollment 200
Condition
Intervention

Intervention Type: Drug

Intervention Name: Curcumin

Description: curcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months

Arm Group Label: Curcumin

Other Name: Curcumin capsules are manufactured by Government Pharmaceutical Organization, Thailand

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

35 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

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 +663739-5085 11001 [email protected] Somlak Chuengsamarn, Medical Doctor Principal Investigator
Location Countries

Thailand

Verification Date

2009-03-01

Responsible Party

Name Title: Assit.Prof. Somlak Chuengsamarn

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

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

Label: Curcumin

Type: Experimental

Description: curcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months

Label: Placebo

Type: No Intervention

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Investigator)

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