Curcumin for Type 2 Diabetic Patients

Srinakharinwirot University

Status and phase: Unknown; Phase 4

Conditions: Cardiovascular Abnormalities; Type 2 Diabetes Mellitus

Treatments: Drug: curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT01052597

SWUEC30/2550

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: curcumin

Curcumin

Experimental group

Treatment:

Drug: curcumin