NCT01368328

Brief Summary

The role of micronutrients in diabetes is not well understood. Studies have demonstrated the relationship between low chromium serum levels and insulin resistance. This study aims to evaluate the effect of chromium nicotinate on increasing insulin sensitivity in patients with type 2 diabetes.

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
57

participants targeted

Target at below P25 for phase_3 type-2-diabetes

Timeline
Completed

Started Mar 2010

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

March 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 7, 2011

Status Verified

February 1, 2011

Enrollment Period

1.3 years

First QC Date

April 12, 2011

Last Update Submit

June 6, 2011

Conditions

Type 2 Diabetes

Keywords

Type 2 DiabetesChromiumInsulin resistance

Outcome Measures

Primary Outcomes (1)

  • Insulin Sensitivity as assessed with homeostatic model assessment (HOMA)

    baseline, 45 days and 90 days

Secondary Outcomes (5)

  • fasting triglycerides, high density lipoprotein cholesterol, low density lipoprotein cholesterol

    baseline, 45 days and 90 days

  • body weight

    baseline, 45 days, 90 days

  • body fat accessed with bioimpedance

    baseline, 45 days, 90 days

  • waist circumference

    baseline, 45 days, 90 days

  • urea and creatinine

    baseline, 45 days, 90 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Chromium nicotinate

Chromium nicotinate 50 mcg

ACTIVE COMPARATOR
Dietary Supplement: Chromium nicotinate

Chromium nicotinate 200 mcg

ACTIVE COMPARATOR
Dietary Supplement: Chromium nicotinate

Interventions

Chromium nicotinateDIETARY_SUPPLEMENT

The intervention is offered during three months. There is a placebo group, chromium nicotinate 50 mcg group and chromium nicotinate 200 mcg group. Each patient is oriented to consume one capsule one hour after lunch and one capsule one hour after dinner.

Chromium nicotinate 200 mcgChromium nicotinate 50 mcgPlacebo

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Type 2 diabetes
  • Body mass index \> 25 kg/m2
  • Increased waist circumference

You may not qualify if:

  • Subjects on insulin
  • Pregnancy
  • Patients with chronic complications as heart disease, nephropathy, retinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goiania Municipal Health Departament

Goiânia, Goiás, 74000000, Brazil

Location

Related Publications (5)

  • Anderson RA. Chromium and insulin resistance. Nutr Res Rev. 2003 Dec;16(2):267-75. doi: 10.1079/NRR200366.

    PMID: 19087394BACKGROUND

  • Kleefstra N, Houweling ST, Bakker SJ, Verhoeven S, Gans RO, Meyboom-de Jong B, Bilo HJ. Chromium treatment has no effect in patients with type 2 diabetes in a Western population: a randomized, double-blind, placebo-controlled trial. Diabetes Care. 2007 May;30(5):1092-6. doi: 10.2337/dc06-2192. Epub 2007 Feb 15.

    PMID: 17303791BACKGROUND

  • Kleefstra N, Houweling ST, Jansman FG, Groenier KH, Gans RO, Meyboom-de Jong B, Bakker SJ, Bilo HJ. Chromium treatment has no effect in patients with poorly controlled, insulin-treated type 2 diabetes in an obese Western population: a randomized, double-blind, placebo-controlled trial. Diabetes Care. 2006 Mar;29(3):521-5. doi: 10.2337/diacare.29.03.06.dc05-1453.

    PMID: 16505499BACKGROUND

  • Martin J, Wang ZQ, Zhang XH, Wachtel D, Volaufova J, Matthews DE, Cefalu WT. Chromium picolinate supplementation attenuates body weight gain and increases insulin sensitivity in subjects with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1826-32. doi: 10.2337/dc06-0254.

    PMID: 16873787BACKGROUND

  • Ghosh D, Bhattacharya B, Mukherjee B, Manna B, Sinha M, Chowdhury J, Chowdhury S. Role of chromium supplementation in Indians with type 2 diabetes mellitus. J Nutr Biochem. 2002 Nov;13(11):690-697. doi: 10.1016/s0955-2863(02)00220-6.

    PMID: 12550067BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

chromium nicotinic acid complex

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Marília Mendonça Guimarães

    Faculdade de Nutrição - Universidade Federal de Goiás

    PRINCIPAL INVESTIGATOR

  • Maria Sebastiana Silva

    Faculdade de Educação Física - Universidade Federal de Goiás

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2011

First Posted

June 7, 2011

Study Start

March 1, 2010

Primary Completion

July 1, 2011

Study Completion

September 1, 2011

Last Updated

June 7, 2011

Record last verified: 2011-02

Locations

BR(1)