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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Srinakharinwirot University

Additional 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
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 July 22, 2014