Curcumin for Type 2 Diabetic Patients

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Antiatherogenic and Antimetabolic Effect of Curcumin in Type 2 Diabetic Patients

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01052597
• Other study ID #: SWUEC30/2550
• Status: Unknown status
• Phase: Phase 4
• First received: January 19, 2010
• Last updated: January 19, 2010
• Start date: July 2009
• Est. completion date: March 2010

Study information

• Verified date: August 2007
• Source: Srinakharinwirot University
• Contact: Somlak Chuengsamarn, Medical Doctor
• Phone: +6637-39-5085
• Email: somlukc[@]swu.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 200
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Abnormalities
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• curcumin
Curcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day 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 determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients		12 months
Secondary	To examine the effectiveness of curcumin on the reduction of blood sugar, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance		12 months