Clinical trial NCT01052597: Curcumin for Type 2 Diabetic Patients
Official title: Antiatherogenic and Antimetabolic Effect of Curcumin in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Cardiovascular Abnormalities
Keywords: Type 2 diabetes
Metabolic syndrome
cardiovascular risk
Lead sponsor: Srinakharinwirot University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Thailand
First posted: 2010-01-20
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: to determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients
timeFrame: 12 months
Secondary outcomes:
measure: To examine the effectiveness of curcumin on the reduction of blood sugar, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance
timeFrame: 12 months
Other outcomes:
Locations:
city: Ongkarak
country: Thailand
facility: HRH Princess Maha Chakri Sirindhorn Medical Center
state: Nakornnayok
Study officials:
affiliation: Srinakarinwirot University
name: Somlak Chuengsamarn, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chuengsamarn S, Rattanamongkolgul S, Phonrat B, Tungtrongchitr R, Jirawatnotai S. Reduction of atherogenic risk in patients with type 2 diabetes by curcuminoid extract: a randomized controlled trial. J Nutr Biochem. 2014 Feb;25(2):144-50. doi: 10.1016/j.jnutbio.2013.09.013. Epub 2013 Nov 6.