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Chromium Effects on Insulin and Vascular Function in People at Risk for Diabetes

Primary Purpose

Obesity, Pre-diabetes, Insulin Resistance

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chromium
Sponsored by
Griffin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring glucose tolerance test, minerals, chromium, complementary and alternative medicine

Eligibility Criteria

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

Inclusion Criteria: Adults 18 years of age or older Identified to have impaired glucose tolerance (IGT), impaired fasting glucose (IFG), or insulin resistance. According to the 1999 World Health Organization (WHO) report, IGT is diagnosed if the following two criteria are met: 1) Plasma glucose two hours after consuming 75g glucose (OGTT) is at least 7.8 mmol/l (140 mg/dl) but below 11.1 mmol/l (200 mg/dl) and 2) Fasting plasma glucose level is less than 7.0 mmol/l (126 mg/dl). IFG is diagnosed by a fasting plasma glucose concentration of 5.6 mmol/l (100 mg dl/l) or greater, but less than 7.0 mmol/l (126 mg dl/l). NCEP ATP III guidelines define 5 components of insulin resistance. At least 3 of the 5 criteria are required for the diagnosis. These components are: Abdominal obesity determined by waist circumference >102cm(>40in) in men or >88cm(>35in) in women; triglyceride level ≥150mg/dL; HDL-C <40mg/dL in men or <50mg/dL in women; blood pressure ≥ 130/≥85mm Hg; and fasting glucose ≥ 100mg/dL. -Connecticut residents willing to travel to Griffin Hospital in Derby, CT Exclusion Criteria: Known diabetes (Fasting Plasma Glucose > 126 mg/dl; 2-hour 75-g OGTT plasma glucose > 200 mg/dl; Diabetes diagnosed by a physician and confirmed by other clinical data); Self-reported hospitalization for treatment of heart disease in past 6 months; Impaired renal function as measured by labwork at initial screening (serum creatinine greater than 2.0 Serum creatinine and urine albumin excretion will be tested every six months throughout the study). Significant changes from baseline or to outside of threshold will be reported to the DSMB for appropriate action, including removal from the study. Self-reported pancreatitis. In the instance that potential subjects report that they are unsure whether they have been diagnosed with this condition, a primary medical doctor's note will be obtained confirming non-diagnosis before inclusion in the study. Self-reported recent or significant abdominal surgery; Self-reported pregnancy and/or intention become pregnancy during the study. Women of child-bearing age will consent to pregnancy testing at baseline, and will agree to avoiding pregnancy by reliable means throughout the duration of the study. Self-reported polycystic ovarian syndrome or irregular menses will be excluded from the study. (In the future, people with self-reported polycystic ovarian syndrome or irregular menses may be allowed in the study, however, because their conditions have the potential of affecting the outcome of BARS testing (a secondary outcome), they will be treated as a subset of the population during data analysis).

Sites / Locations

  • Yale-Griffin Prevention Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

500/1000 mcg oral chromium taken daily or placebo (crossover)

500/1000 mcg oral chromium taken daily or placebo (crossover)

Outcomes

Primary Outcome Measures

Serum Insulin
2-hour Oral Glucose Tolerance Test
Homeostasis Model Assessment for Insulin Resistance (HOMA-IR)

Secondary Outcome Measures

HbA1C
blood pressure
lipid profile (total cholesterol, LDL, HDL, TG)
BMI
urine albumin:creatinine ratio
endothelial function measures as percent flow-mediated dilitation (FMD).

Full Information

First Posted
August 25, 2003
Last Updated
October 14, 2010
Sponsor
Griffin Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT00067626
Brief Title
Chromium Effects on Insulin and Vascular Function in People at Risk for Diabetes
Official Title
Chromium Effects on Insulin and Vascular Function in People at Risk for Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Griffin Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Yale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the effects of Chromium on glucose tolerance and endothelial function in people at risk for type II diabetes.
Detailed Description
Impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and insulin resistance (IR) are precursors to type II diabetes mellitus (DM) and its sequelae, and are cardiac risk factors in their own right. The worsening epidemic of DM in the US, along with the increasing prevalence of obesity, insulin resistance, and IGT, render the identification of promising interventions for these states a matter of some urgency. While lifestyle interventions based on dietary pattern and physical activity can delay or prevent the onset of diabetes, and reduce cardiovascular risk, adherence at the population level is severely limiting. Pharmacotherapy offers promise for diabetes prevention, but with associated high costs, unacceptability to many patients, and potential toxicity. In this context, the potential role of chromium (Cr), an insulin co-factor, in IGT is of great interest. Chromium use is widespread, but evidence of any therapeutic effect is limited. Proposed, therefore, is a randomized, double-blind, placebo controlled pilot trial conducted at the Yale Prevention Research Center, to investigate the effects of daily Cr for 6 months at two dose levels on serum measures of glucose tolerance, and on endothelial function, in adults with IGT, IFG, and IR. A modified crossover design will allow for paired and unpaired analyses including comparison of both 500 mcg and 1,000 mcg of Cr daily to placebo; comparison between 500 mcg and 1000 mcg of chromium; and evaluation of Cr washout time. The study is powered to detect a clinically meaningful effect of Cr supplementation at either dose on glucose control, and to compare the two doses for equivalence. The study will investigate effects of Cr on both measures of glucose tolerance (glucose, insulin, OGTT) and brachial artery endothelial function, thus combining serum measures with a physiologic test of Cr effects on the vasculature. The proposed study will generate much needed data regarding the efficacy of Cr in those at risk for type II diabetes and offers the promise of guiding practice, as well as directing future study. By contributing to knowledge related to potential diabetes prevention strategies, this study addresses one of the more pressing public health issues in the US today. Risk to human subjects in this study is a minor increment over minimal due to the administration of nitroglycerin as a control in BARS testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Pre-diabetes, Insulin Resistance, Impaired Glucose Tolerance, Impaired Fasting Glucose
Keywords
glucose tolerance test, minerals, chromium, complementary and alternative medicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
500/1000 mcg oral chromium taken daily or placebo (crossover)
Arm Title
2
Arm Type
Experimental
Arm Description
500/1000 mcg oral chromium taken daily or placebo (crossover)
Intervention Type
Dietary Supplement
Intervention Name(s)
Chromium
Intervention Description
500/1000 mcg oral chromium picolinate taken daily or placebo (crossover)
Primary Outcome Measure Information:
Title
Serum Insulin
Time Frame
Baseline, 6, 12, 18 months
Title
2-hour Oral Glucose Tolerance Test
Time Frame
Baseline, 6, 12, 18 months
Title
Homeostasis Model Assessment for Insulin Resistance (HOMA-IR)
Time Frame
Baseline, 6, 12, 18 months
Secondary Outcome Measure Information:
Title
HbA1C
Time Frame
Baseline, 6, 12, 18 months
Title
blood pressure
Time Frame
Baseline, 6, 12, 18 months
Title
lipid profile (total cholesterol, LDL, HDL, TG)
Time Frame
Baseline, 6, 12, 18 months
Title
BMI
Time Frame
Baseline, 6, 12, 18 months
Title
urine albumin:creatinine ratio
Time Frame
Baseline, 6, 12, 18 months
Title
endothelial function measures as percent flow-mediated dilitation (FMD).
Time Frame
Baseline, 6, 12, 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults 18 years of age or older Identified to have impaired glucose tolerance (IGT), impaired fasting glucose (IFG), or insulin resistance. According to the 1999 World Health Organization (WHO) report, IGT is diagnosed if the following two criteria are met: 1) Plasma glucose two hours after consuming 75g glucose (OGTT) is at least 7.8 mmol/l (140 mg/dl) but below 11.1 mmol/l (200 mg/dl) and 2) Fasting plasma glucose level is less than 7.0 mmol/l (126 mg/dl). IFG is diagnosed by a fasting plasma glucose concentration of 5.6 mmol/l (100 mg dl/l) or greater, but less than 7.0 mmol/l (126 mg dl/l). NCEP ATP III guidelines define 5 components of insulin resistance. At least 3 of the 5 criteria are required for the diagnosis. These components are: Abdominal obesity determined by waist circumference >102cm(>40in) in men or >88cm(>35in) in women; triglyceride level ≥150mg/dL; HDL-C <40mg/dL in men or <50mg/dL in women; blood pressure ≥ 130/≥85mm Hg; and fasting glucose ≥ 100mg/dL. -Connecticut residents willing to travel to Griffin Hospital in Derby, CT Exclusion Criteria: Known diabetes (Fasting Plasma Glucose > 126 mg/dl; 2-hour 75-g OGTT plasma glucose > 200 mg/dl; Diabetes diagnosed by a physician and confirmed by other clinical data); Self-reported hospitalization for treatment of heart disease in past 6 months; Impaired renal function as measured by labwork at initial screening (serum creatinine greater than 2.0 Serum creatinine and urine albumin excretion will be tested every six months throughout the study). Significant changes from baseline or to outside of threshold will be reported to the DSMB for appropriate action, including removal from the study. Self-reported pancreatitis. In the instance that potential subjects report that they are unsure whether they have been diagnosed with this condition, a primary medical doctor's note will be obtained confirming non-diagnosis before inclusion in the study. Self-reported recent or significant abdominal surgery; Self-reported pregnancy and/or intention become pregnancy during the study. Women of child-bearing age will consent to pregnancy testing at baseline, and will agree to avoiding pregnancy by reliable means throughout the duration of the study. Self-reported polycystic ovarian syndrome or irregular menses will be excluded from the study. (In the future, people with self-reported polycystic ovarian syndrome or irregular menses may be allowed in the study, however, because their conditions have the potential of affecting the outcome of BARS testing (a secondary outcome), they will be treated as a subset of the population during data analysis).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L Katz, MD, MPH
Organizational Affiliation
Yale University/Yale-Griffin Prevention Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale-Griffin Prevention Research Center
City
Derby
State/Province
Connecticut
ZIP/Postal Code
06418
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20634174
Citation
Ali A, Ma Y, Reynolds J, Wise JP Sr, Inzucchi SE, Katz DL. Chromium effects on glucose tolerance and insulin sensitivity in persons at risk for diabetes mellitus. Endocr Pract. 2011 Jan-Feb;17(1):16-25. doi: 10.4158/EP10131.OR.
Results Reference
result
Links:
URL
http://www.yalegriffinprc.org
Description
Yale-Griffin Prevention Research Center

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Chromium Effects on Insulin and Vascular Function in People at Risk for Diabetes

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