Curcumin for Type 2 Diabetic Patients

NCT01052597 | Unknown Phase 4

• 1 other identifier: SWUEC30/2550
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

There are evidence that there is an association between insulin resistance and prolonged hyperinsulinemia or hyperglycemia in Type 2 diabetic patients. This will trigger oxidative stress system via reactive oxygen species (ROS) and lead to a high level of Nitric oxide. This can contribute to a significant change in blood vessel and could end up with the complications from cardiovascular disease and increased mortality rate of type 2 diabetic patients. The purpose of the present study was to examine the effectiveness of the curcumin in type 2 diabetic patients on the reduction of atherosclerosis events by examining pulse-wave velocity (PWV) and plasma high-sensitivity C-reactive protein (CRP) test and on blood sugar lowering, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance.

Conditions

Type 2 Diabetes Mellitus; Cardiovascular Abnormalities

Keywords

Type 2 diabetes; Metabolic syndrome; cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• to determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients

  12 months

Secondary Outcomes (1)

• To examine the effectiveness of curcumin on the reduction of blood sugar, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance

  12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: curcumin

Curcumin

EXPERIMENTAL

Drug: curcumin

Interventions

curcumin DRUG

Curcumin capsule contains 250 mg curcuminoids, 2 capsule per time, 3 times a day for 12 months

Also known as: Manufactured by Government Pharmaceutical Organization, Thailand

Curcumin; Placebo

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with hyperlipidemia (Cholesterol ≥ 200 mg/dl, TG ≥ 150 mg/dl, LDL ≥ 100 mg/dl and HDL ≥ 35 mg/dl)
• Patient with hypertension (Blood pressure ≥ 130/85 mmHg or take hypertensive drugs)
• Obesity (BMI ≥ 25)

You may not qualify if:

• Current diagnosis of cardiovascular disease, i.e., coronary arterial disease and cerebrovascular disease
• Current diagnosis of end stage renal function with serum creatinine \> 2.0 mg/dl or on renal dialysis
• Current diagnosis of cirrhosis with ALT ≥ 3 times of normal range

Sponsors & Collaborators

• Srinakharinwirot University: lead
• Ministry of Health, Thailand: collaborator

Study Sites (1)

HRH Princess Maha Chakri Sirindhorn Medical Center

Ongkarak, Nakornnayok, 26120, Thailand

RECRUITING

Related Publications (1)

• Chuengsamarn S, Rattanamongkolgul S, Phonrat B, Tungtrongchitr R, Jirawatnotai S. Reduction of atherogenic risk in patients with type 2 diabetes by curcuminoid extract: a randomized controlled trial. J Nutr Biochem. 2014 Feb;25(2):144-50. doi: 10.1016/j.jnutbio.2013.09.013. Epub 2013 Nov 6.

  PMID: 24445038 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Abnormalities; Metabolic Syndrome

Interventions

Curcumin; Tacrine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Somlak Chuengsamarn, Medical Doctor

  Srinakarinwirot University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Somlak Chuengsamarn, Medical Doctor

CONTACT

+6637-39-5085; somlukc@swu.ac.th

Study Design

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

Study Record Dates

• First Submitted: January 19, 2010
• First Posted: January 20, 2010
• Study Start: July 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 20, 2010

Record last verified: 2007-08

Locations

TH (1)