NCT01052025

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4 type-2-diabetes

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

January 20, 2010

Status Verified

March 1, 2009

Enrollment Period

7 months

First QC Date

January 19, 2010

Last Update Submit

January 19, 2010

Conditions

Type 2 DiabetesPre-diabetesInsulin ResistanceCardiovascular Risk

Outcome Measures

Primary Outcomes (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)

    12 months

Secondary Outcomes (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

    12 months

Study Arms (2)

Curcumin

EXPERIMENTAL

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

Drug: Curcumin

Placebo

NO INTERVENTION

Interventions

CurcuminDRUG

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

Also known as: Curcumin capsules are manufactured by Government Pharmaceutical Organization, Thailand
Curcumin

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HRH Princess Maha Chakri Sirindhorn Medical Center

Ongkarak, Nakornnayok, 26120, Thailand

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22773702DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Glucose IntoleranceInsulin Resistance

Interventions

CurcuminTacrine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemiaHyperinsulinism

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicAminoacridinesAcridinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Somlak Chuengsamarn, Medical Doctor

    Srinakarinwirot University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Somlak Chuengsamarn, Medical Doctor

CONTACT

+663739-5085somlukc@swu.ac.th

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 20, 2010

Study Start

August 1, 2009

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

January 20, 2010

Record last verified: 2009-03

Locations

TH(1)