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Curcumin for Type 2 Diabetic Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Srinakharinwirot University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Health, Thailand
Information provided by:
Srinakharinwirot University
ClinicalTrials.gov Identifier:
NCT01052597
First received: January 19, 2010
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Cardiovascular Abnormalities
 Drug: curcumin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Antiatherogenic and Antimetabolic Effect of Curcumin in Type 2 Diabetic Patients

Resource links provided by NLM:

Drug Information available for: Curcumin
U.S. FDA Resources

Further study details as provided by Srinakharinwirot University:

Primary Outcome Measures:
  • to determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the effectiveness of curcumin on the reduction of blood sugar, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 19, 2010
Last Updated: January 19, 2010
Health Authority: Thailand: Ministry of Public Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013