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
Recruitment status was Recruiting
Sponsor:
Srinakharinwirot University
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
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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
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:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Insulin Resistance Glucose Intolerance Prediabetic State 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 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 23, 2013