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Effect of Chromium Picolinate on Insulin Sensitivity in Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
chromium picolinate 1000 mcg daily vs placebo
Placebo
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring insulin, glucose, chromium

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Chromium Picolinate

Placebo

Arm Description

Chromium

Placebo

Outcomes

Primary Outcome Measures

Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps

Secondary Outcome Measures

glucose control
body weight and fat distribution, myocellular and intrahepatic lipid content as assessed with MRS scans

Full Information

First Posted
November 9, 2006
Last Updated
April 7, 2016
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT00398853
Brief Title
Effect of Chromium Picolinate on Insulin Sensitivity in Type 2 Diabetes
Official Title
Chromium and Insulin Action
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Detailed Description: The primary clinical strategy to improve metabolic control in patients with Type 2 diabetes consists of lifestyle modification combined with pharmacologic intervention. However, alternative strategies, e.g. nutritional supplementation with over-the-counter agents, are extensively practiced by a large number of patients and are frequently undertaken without first informing the medical provider. Unfortunately, considerable controversy exists regarding use of dietary supplements in subjects with diabetes because efficacy data for many of the supplements consists of only uncontrolled studies and anecdotal reports. As such, there is a paucity of data in humans in regard to the effect of most commercially available supplements to improve metabolic abnormalities. One supplement that has attracted considerable clinical interest is chromium (Cr). However, routine use of Cr in subjects with diabetes is not currently recommended. In part, the controversy surrounding Cr supplementation stems from the lack of definitive randomized trials, the lack of "gold standard" techniques to assess glucose metabolism in the studies reported, the use of differing doses and formulation , and the study of heterogeneous study populations. As such, conflicting data has been reported that has contributed greatly to the confusion among healthcare providers concerning Cr supplementation. In order to provide a comprehensive clinical evaluation of Cr, we conducted a randomized, double-blinded, placebo-controlled trial in subjects with Type 2 diabetes. Individuals had baseline measures consisting of oral glucose tolerance testing, body fat and adiposity assessed, and then used established techniques to assess insulin sensitivity with hyperinsulinemic-euglycemic clamps. Individuals were evaluated for 6 months at which time repeat testing was done.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
insulin, glucose, chromium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chromium Picolinate
Arm Type
Experimental
Arm Description
Chromium
Arm Title
Placebo
Arm Type
Other
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
chromium picolinate 1000 mcg daily vs placebo
Intervention Description
chromium picolinate 1000 mcg daily vs placebo
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps
Time Frame
at study enpoints
Secondary Outcome Measure Information:
Title
glucose control
Time Frame
at study endpoints
Title
body weight and fat distribution, myocellular and intrahepatic lipid content as assessed with MRS scans
Time Frame
at study endpoints

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Cefalu, MD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29307520
Citation
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.
Results Reference
derived
PubMed Identifier
20022616
Citation
Cefalu 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.
Results Reference
derived

Learn more about this trial

Effect of Chromium Picolinate on Insulin Sensitivity in Type 2 Diabetes

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