Curcumin Therapy in Patients With Impaired Glucose Tolerance and Insulin Resistance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Srinakharinwirot University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Health, Thailand
Information provided by:
Srinakharinwirot University
ClinicalTrials.gov Identifier:
NCT01052025
First received: January 19, 2010
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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 Intervention Phase
Type 2 Diabetes
Pre-diabetes
Insulin Resistance
Cardiovascular Risk
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: 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

Resource links provided by NLM:


Further study details as provided by Srinakharinwirot University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided by Srinakharinwirot University

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

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Insulin Resistance
Diabetes Mellitus, Type 2
Diabetes Mellitus
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
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 September 16, 2014