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Curcumin Therapy in Patients With Impaired Glucose Tolerance and Insulin Resistance

S

Srinakharinwirot University

Status and phase

Unknown
Phase 4

Conditions

Pre-diabetes
Insulin Resistance
Cardiovascular Risk
Type 2 Diabetes

Treatments

Drug: Curcumin

Study type

Interventional

Funder types

Other

Identifiers

NCT01052025
SWUEC9/2552

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

35+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Curcumin
Experimental group
Description:
curcumin capsule contains 250 mg curcuminoiods, 3 capsules per time, 2 times a day before meal for 12 months
Treatment:
Drug: Curcumin
Placebo
No Intervention group

Trial contacts and locations

1

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Central trial contact

Somlak Chuengsamarn, Medical Doctor

Data sourced from clinicaltrials.gov

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