NCT02529969

Brief Summary

Diabetes mellitus is the most common endocrine disorder, causes many complications such as micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed, but most of them have side effects. Recently, the use of natural plant products has gained more attention among scientists in order to prevent diabetic vascular complications. Curcumin is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory, anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in reducing glycemic index and hyperlipidemia in rodent models and is relatively inexpensive and safe. Most of the studies conducted on animal model, and just a few of them are on human model. The present study was planned to evaluate the effects of curcumin supplementation on serum levels of lipid profile and inflammatory markers in patients with type 2 diabetes

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

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

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Last Updated

August 20, 2015

Status Verified

July 1, 2015

Enrollment Period

6 months

First QC Date

August 19, 2015

Last Update Submit

August 19, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Triglyceride

    12 weeks

Secondary Outcomes (1)

  • C-Reactive Protein

    12 weeks

Study Arms (2)

intervention

ACTIVE COMPARATOR

500 mg curcumin capsule

Dietary Supplement: curcumin

placebo

PLACEBO COMPARATOR

500 mg placebo

Dietary Supplement: Placebo

Interventions

curcuminDIETARY_SUPPLEMENT
intervention
PlaceboDIETARY_SUPPLEMENT
placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tendency to participate
  • Age range of 40-65
  • Suffering from diabetes type 2 ( between 1 to 10 yeares)
  • BMI 18/5-30
  • Patients with diabetes who administer oral hypoglycemic agents and do not use

You may not qualify if:

  • patients with liver diseases
  • patients with kidney diseases
  • patients with inflammatory diseases
  • patients with liver diseases
  • Administering herbal agents
  • Administering multivitamins and minerals in past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NNFTRI clinic

Tehran, Tehran Province, 19435, Iran

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 19, 2015

First Posted

August 20, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2016

Last Updated

August 20, 2015

Record last verified: 2015-07

Locations