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Curcumin Therapy in Patients With Impaired Glucose Tolerance and Insulin Resistance

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ClinicalTrials.gov Identifier: NCT01052025
Recruitment Status : Unknown
Verified March 2009 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:
The incidence rate of type 2 diabetes in Thai populations is high and increasing every year. Cardiovascular disease is the main complication of this disease, which has been defined as an important cause of death among Diabetic patients. This disease is now becoming a major health problem and causes a great economic loss to the country. Evidence shows that Curcumin, Thai herbal medicine, has the effectiveness of prevention and delay of type 2 diabetes. However, there is no scientific study that aims to prove the efficacy of this herb particularly for prevention and delay the disease in Patients with impaired glucose tolerance (pre-diabetes) and insulin resistance.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Pre-diabetes Insulin Resistance Cardiovascular Risk Drug: Curcumin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Antiatherogenic and Antimetabolic Effect of Curcumin Therapy in the Prevention and Delay of Type 2 Diabetic in Patients With Impaired Glucose Tolerance and Insulin Resistance
Study Start Date : August 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Curcumin
curcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months
Drug: Curcumin
curcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months
Other Name: Curcumin capsules are manufactured by Government Pharmaceutical Organization, Thailand
No Intervention: Placebo



Primary Outcome Measures :
  1. To examine the efficacy of curcumin on the delay of degenerative beta-cells in pancrease for protection of Type 2 Diabetes in patients with impaired glucose tolerance (Pre-diabetes) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. To examine the efficacy of curcumin on the reduction of blood sugar level, lipid profile, insulin resistance status and oxidative stress status in Pre-diabetes patients [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged 35 years or older with an abnormal fasting plasma glucose (100-125 mg/dl) or with insulin resistance (140-199 mg/dl) by using 75 mg of glucose OGTT.

Exclusion Criteria:

  • Have been diagnosed with diabetes by the results of FPG >/=126 mg/dl
  • Present with secondary peripheral arterial disease (PAD)
  • Present with cardiovascular diseases such as coronary arterial disease and cerebrovascular disease
  • Receive anticoagulant drugs that have an effect on the measurement of pulse wave velocity (PWV)
  • Receive antihypertensive or lipid-lowering drugs (ARB, ACEI, fenofibrate, atorvastatin, rosuvastatin, fluvastatin) that have an effect on the measurement of C-reactive protein (CRP)
  • Present with kidney failure (serum creatinine > 2.0 mg/dl) or in the process of renal dialysis
  • Present with hepatitis (ALT level >/= 3 times the upper limit)
  • Receive any herbal medications or curcumin
  • Present with high blood sugar from other causes apart from type 2 diabetes such as receiving steroid drugs, cancer or pancreatic cyst
  • Present with infection or inflammation that have effect on the level of CRP
  • Pregnancy or breastfeeding
  • Have a history of gall bladder diseases or removal

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): NCT01052025


Contacts
Contact: Somlak Chuengsamarn, Medical Doctor +663739-5085 ext 11001 somlukc@swu.ac.th

Locations
Thailand
HRH Princess Maha Chakri Sirindhorn Medical Center Recruiting
Ongkarak, Nakornnayok, Thailand, 26120
Contact: Somlak Chuengsamarn, Medical Doctor    +663739-5085 ext 11001    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: Assit.Prof. Somlak Chuengsamarn, Department of Internal Medicines, Faculty of Medicine, Srinakarinwirot University
ClinicalTrials.gov Identifier: NCT01052025     History of Changes
Other Study ID Numbers: SWUEC9/2552
First Posted: January 20, 2010    Key Record Dates
Last Update Posted: January 20, 2010
Last Verified: March 2009

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Diabetes Mellitus
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Hyperglycemia
Curcumin
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