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Curcumin Therapy in Patients With Impaired Glucose Tolerance and Insulin Resistance

Primary Purpose

Type 2 Diabetes, Pre-diabetes, Insulin Resistance

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Curcumin

About this trial

This is an interventional prevention trial for Type 2 Diabetes

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

HRH Princess Maha Chakri Sirindhorn Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Curcumin

Placebo

Arm Description

curcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months

Outcomes

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)

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

Full Information

NCT ID

NCT01052025

First Posted

January 19, 2010

Last Updated

January 19, 2010

Sponsor

Srinakharinwirot University

Collaborators

Ministry of Health, Thailand

1. Study Identification

Unique Protocol Identification Number

NCT01052025

Brief Title

Curcumin Therapy in Patients With Impaired Glucose Tolerance and Insulin Resistance

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 Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Unknown status

Study Start Date

August 2009 (undefined)

Primary Completion Date

March 2010 (Anticipated)

Study Completion Date

April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Srinakharinwirot University

Collaborators

Ministry of Health, Thailand

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Pre-diabetes, Insulin Resistance, Cardiovascular Risk

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Curcumin

Arm Type

Experimental

Arm Description

curcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months

Arm Title

Placebo

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Curcumin

Other Intervention Name(s)

Curcumin capsules are manufactured by Government Pharmaceutical Organization, Thailand

Intervention Description

curcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Somlak Chuengsamarn, Medical Doctor

Phone

+663739-5085

Ext

11001

somlukc@swu.ac.th

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Somlak Chuengsamarn, Medical Doctor

Organizational Affiliation

Srinakarinwirot University

Official's Role

Principal Investigator

Facility Information:

Facility Name

HRH Princess Maha Chakri Sirindhorn Medical Center

City

Ongkarak

State/Province

Nakornnayok

ZIP/Postal Code

26120

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Somlak Chuengsamarn, Medical Doctor

Phone

+663739-5085

Ext

11001

somlukc@swu.ac.th

First Name & Middle Initial & Last Name & Degree

Somlak Chuengsamarn, Medical Doctor

12. IPD Sharing Statement

Citations:

PubMed Identifier

22773702

Citation

Chuengsamarn S, Rattanamongkolgul S, Luechapudiporn R, Phisalaphong C, Jirawatnotai S. Curcumin extract for prevention of type 2 diabetes. Diabetes Care. 2012 Nov;35(11):2121-7. doi: 10.2337/dc12-0116. Epub 2012 Jul 6.

Results Reference

derived

Learn more about this trial

Curcumin Therapy in Patients With Impaired Glucose Tolerance and Insulin Resistance

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