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ObesityPhase 2NCT00067626

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

A Phase 2 study testing Chromium in people with Obesity and Pre-diabetes, run by Griffin Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Pre-diabetes, Insulin Resistance
What is being tested?
Chromium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Apr 2005to Mar 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale-Griffin Prevention Research Center

    Derby, Connecticut, 06418

Other trials in United States

About this study

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.

Read the 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.

Being tested
Chromium
Keywords
glucose tolerance test, minerals, chromium, complementary and alternative medicine
Medical subject headings
Obesity, Glucose Intolerance, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChromiumDietary supplement

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

Study groups in NCT00067626
Study groupRoleWhat they receive
1Experimental500/1000 mcg oral chromium taken daily or placebo (crossover)
Receives: Dietary Supplement: Chromium
2Experimental500/1000 mcg oral chromium taken daily or placebo (crossover)
Receives: Dietary Supplement: Chromium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Insulin

    Measured: Baseline, 6, 12, 18 months

  2. 2-hour Oral Glucose Tolerance Test

    Measured: Baseline, 6, 12, 18 months

  3. Homeostasis Model Assessment for Insulin Resistance (HOMA-IR)

    Measured: Baseline, 6, 12, 18 months

Secondary outcomes (6)

  1. HbA1C

    Measured: Baseline, 6, 12, 18 months

  2. blood pressure

    Measured: Baseline, 6, 12, 18 months

  3. lipid profile (total cholesterol, LDL, HDL, TG)

    Measured: Baseline, 6, 12, 18 months

  4. BMI

    Measured: Baseline, 6, 12, 18 months

  5. urine albumin:creatinine ratio

    Measured: Baseline, 6, 12, 18 months

  6. endothelial function measures as percent flow-mediated dilitation (FMD).

    Measured: Baseline, 6, 12, 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2003 (estimated)
  2. Study startApr 2005
  3. Primary completionMar 2009
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00067626
Sponsor's protocol ID
R21AT001332
Other IDs
R21AT001332
Status last verified
Oct 2010
First submitted
25 Aug 2003
Last updated
15 Oct 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20634174

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chromium in people with Obesity and Pre-diabetes, run by Griffin Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Insulin (time frame: Baseline, 6, 12, 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00067626, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2010.

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