Chromium's Effect on Insulin Resistance in Obesity

NCT ID: NCT00997659

Last Updated: 2011-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This research is to investigate the nutritional supplement chromium picolinate. A large number of people use chromium picolinate from health food stores to improve the function of the hormone insulin. The investigators are testing how effective this supplement is and are also monitoring its safety. In patients with diabetes, chromium has been shown to increase sensitivity to the hormone insulin. Since obesity can cause insensitivity or resistance to insulin, the investigators are studying obese individuals with documented insulin resistance. The investigators would like to know if chromium is also effective in treating the insulin resistance associated with obesity.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insulin Resistance Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

chromium picolinate

Group Type EXPERIMENTAL

chromium picolinate

Intervention Type DIETARY_SUPPLEMENT

1000 mg per day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

chromium picolinate

1000 mg per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. age \> 18 years;
2. a BMI greater or equal to 30; AND
3. an abnormal 2 hour postprandial glucose (greater than 140 mg/dl but less than 200 mg/dl) following 75 grams of a glucose load.

Exclusion Criteria

1. positive pregnancy test (all women must have a negative pregnancy test before beginning protocol);
2. diagnosis of cancer;
3. acute illness of any sort, however, patients may be enrolled once they are stable;
4. hemoglobin less than 11.0 g/dl or hemodynamically unstable;
5. creatinine greater than or equal to 1.5 mg/dl;
6. liver dysfunction as evidenced by elevations in transaminases 2-fold higher than upper limit of normal;
7. use of certain medications within the past month (e.g., glucocorticoids).
8. untreated hypertension (systolic BP \> 150 mmHG, diastolic BP\>IOO mmHG);
9. patients with diabetes mellitus;
10. hypogonadism;
11. abnormal thyroid function (serum T4 \< 4 or \> 12; TSH \< 0.35 or \> 5.5) (12) any chronic liver or kidney disease; OR
12. polycystic ovarian syndrome.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stony Brook University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stony Brook University GCRC

Stony Brook, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2007-5689

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.