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Curcumin for Type 2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01052597
Recruitment Status : Unknown
Verified August 2007 by Srinakharinwirot University.
Recruitment status was:  Recruiting
First Posted : January 20, 2010
Last Update Posted : January 20, 2010
Sponsor:
Collaborator:
Ministry of Health, Thailand
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Cardiovascular Abnormalities Drug: curcumin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Antiatherogenic and Antimetabolic Effect of Curcumin in Type 2 Diabetic Patients
Study Start Date : July 2009
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: curcumin
Curcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day for 12 months
Other Name: Manufactured by Government Pharmaceutical Organization, Thailand

Experimental: Curcumin Drug: curcumin
Curcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day for 12 months
Other Name: Manufactured by Government Pharmaceutical Organization, Thailand




Primary Outcome Measures :
  1. to determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. To examine the effectiveness of curcumin on the reduction of blood sugar, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance [ Time Frame: 12 months ]


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052597


Contacts
Contact: Somlak Chuengsamarn, Medical Doctor +6637-39-5085 somlukc@swu.ac.th

Locations
Thailand
HRH Princess Maha Chakri Sirindhorn Medical Center Recruiting
Ongkarak, Nakornnayok, Thailand, 26120
Contact: Somlak Chuengsamarn, Medical Doctor    +6637-39-5085    somlukc@swu.ac.th   
Principal Investigator: Somlak Chuengsamarn, Medical Doctor         
Sponsors and Collaborators
Srinakharinwirot University
Ministry of Health, Thailand
Investigators
Principal Investigator: Somlak Chuengsamarn, Medical Doctor Srinakarinwirot University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assist.Prof. Somlak Chuengsamarn, Department of Internal Medicines, Faculty of Medicine, Srinakarinwirot University
ClinicalTrials.gov Identifier: NCT01052597     History of Changes
Other Study ID Numbers: SWUEC30/2550
First Posted: January 20, 2010    Key Record Dates
Last Update Posted: January 20, 2010
Last Verified: August 2007

Keywords provided by Srinakharinwirot University:
Type 2 diabetes
Metabolic syndrome
cardiovascular risk

Additional relevant MeSH terms:
Curcumin
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Abnormalities
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Congenital Abnormalities
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action