Curcumin Therapy in Patients With Impaired Glucose Tolerance and Insulin Resistance

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01052025
• Other study ID #: SWUEC9/2552
• Status: Recruiting
• Phase: Phase 4
• First received: January 19, 2010
• Last updated: January 19, 2010
• Start date: August 2009
• Est. completion date: April 2010

Study information

• Verified date: March 2009
• Source: Srinakharinwirot University
• Contact: Somlak Chuengsamarn, Medical Doctor
• Phone: +663739-5085
• Email: somlukc[@]swu.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Risk
• Diabetes Mellitus
• Glucose Intolerance
• Insulin Resistance
• Pre-diabetes
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Thailand	HRH Princess Maha Chakri Sirindhorn Medical Center	Ongkarak	Nakornnayok

Sponsors (2)

Lead Sponsor	Collaborator
Srinakharinwirot University	Ministry of Health, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No