NCT00283777

Brief Summary

The effect of Chromium to improve glucose levels in diabetes is controversial. The hypothesis of the study was to evaluate the effect of supplementing the diet of individuals with Type 2 diabetes with chromium picolinate and assessing the effect on blood glucose levels and insulin sensitivity

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4 type-2-diabetes

Timeline
Completed

Started Aug 1998

Longer than P75 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

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, 1998

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2006

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

4.4 years

First QC Date

January 26, 2006

Last Update Submit

April 7, 2016

Conditions

Type 2 Diabetes

Keywords

insulinglucosebody weightchromium

Outcome Measures

Primary Outcomes (1)

  • Insulin Senstivity, glycated hemoglobin

Secondary Outcomes (1)

  • weight, body composition

Interventions

Chromium PicolinateDRUG

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes on diet therapy or low dose oral agent -

You may not qualify if:

  • Significant cardiovascular, hepatic or renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont

Burlington, Vermont, 05410, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin ResistanceBody Weight

Interventions

picolinic acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William Cefalu, MD

    University of Vermont and Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 30, 2006

Study Start

August 1, 1998

Primary Completion

January 1, 2003

Study Completion

April 1, 2003

Last Updated

April 8, 2016

Record last verified: 2016-04

Locations

US(1)