Curcumin for Type 2 Diabetic Patients

Phase 4

• Conditions: Type 2 Diabetes Mellitus; Cardiovascular Abnormalities
• Interventions: Drug: curcumin

• Registration Number: NCT01052597
• Lead Sponsor: Srinakharinwirot University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-08
• Study Start: 2009-07
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-19
• Last Update Submitted: 2010-01-19
• Study First Posted: 2010-01-20
• Last Update Posted: 2010-01-20
• Primary Completion: 2010-02
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	curcumin	-
Curcumin	curcumin	-

Primary Outcome Measures

Name	Time	Method
to determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients	12 months

Secondary Outcome Measures

Name	Time	Method
To examine the effectiveness of curcumin on the reduction of blood sugar, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance	12 months

Trial Locations

Locations (1)

HRH Princess Maha Chakri Sirindhorn Medical Center; 🇹🇭 Ongkarak, Nakornnayok, Thailand