Effect of Chromium Picolinate on Insulin Sensitivity in Type 2 Diabetes
Chromium and Insulin Action
1 other identifier
interventional
100
1 country
1
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 of the supplementation on insulin sensitivity as assessed with hyperinsulinemic clamps
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 type-2-diabetes
Started Oct 2003
Longer than P75 for phase_4 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 9, 2006
CompletedFirst Posted
Study publicly available on registry
November 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedApril 8, 2016
April 1, 2016
5.5 years
November 9, 2006
April 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps
at study enpoints
Secondary Outcomes (2)
glucose control
at study endpoints
body weight and fat distribution, myocellular and intrahepatic lipid content as assessed with MRS scans
at study endpoints
Study Arms (2)
Chromium Picolinate
EXPERIMENTALChromium
Placebo
OTHERPlacebo
Interventions
chromium picolinate 1000 mcg daily vs placebo
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- On no meds to alter glucose metabolism
- age greater than 25 years old
- Fasting glucose greater than 125 mg/dl at screening
You may not qualify if:
- Subjects on insulin
- Sujbects on meds that alter glucose metabolism
- Use of glitazones
- C0-existing disorders in major organ systems such as heart, kidneys, liver
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Related Publications (2)
Broskey NT, Obanda DN, Burton JH, Cefalu WT, Ravussin E. Skeletal muscle ceramides and daily fat oxidation in obesity and diabetes. Metabolism. 2018 May;82:118-123. doi: 10.1016/j.metabol.2017.12.012. Epub 2018 Jan 4.
PMID: 29307520DERIVEDCefalu WT, Rood J, Pinsonat P, Qin J, Sereda O, Levitan L, Anderson RA, Zhang XH, Martin JM, Martin CK, Wang ZQ, Newcomer B. Characterization of the metabolic and physiologic response to chromium supplementation in subjects with type 2 diabetes mellitus. Metabolism. 2010 May;59(5):755-62. doi: 10.1016/j.metabol.2009.09.023. Epub 2009 Dec 22.
PMID: 20022616DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Cefalu, MD
Pennington Biomedical Research Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 9, 2006
First Posted
November 14, 2006
Study Start
October 1, 2003
Primary Completion
April 1, 2009
Study Completion
June 1, 2009
Last Updated
April 8, 2016
Record last verified: 2016-04