Insulin ResistanceNCT02006914
Novel Therapy for Glucose Intolerance in HIV Disease
An observational study of Insulin Resistance, run by Stony Brook University at 1 site in United States.
Trial summary
This research is to investigate the nutritional supplement chromium picolinate. The investigators are testing to see how effective this supplement is in treating insulin resistance associated with HIV disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Chromium Picolinate
- Type of treatment
- Pill or oral medicine
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Apr 2012
- Phase
- Observational
- 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
Study population: Anyone with a positive diagnosis of HIV disease.
Who may be able to join
- Age > 18 years and a diagnosis of HIV+ andlor AlDS made by standard CDC criteria.
Who cannot join
- positive pregnancy test (all women must have a negative pregnancy test before beginning protocol);
- diagnosis of cancer;
- acute illness of any sort, however, patients may be enrolled once they are stable;
- hemoglobin less than 11.0 gldl or hemodynamically unstable;
- creatinine greater than or equal to 1.5 mgldl;
- liver dysfunction as evidenced by elevations in transaminases 2-fold higher than upper limit of normal;
Show all 15Show fewer
- use of certain medications within the past month (e.g., glucocorticoids).
- untreated hypertension (systolic BP > 150 mmHG, diastolic BP>100 mmHG);
- patients with diabetes mellitus
- hypogonadism
- abnormal thyroid function (serum T'4 < 4 or > 12; TSH < 0.35 or > 5.5)
- hepatitis C infection (if patients have had prior therapy and are now stable with no evidence of active infection they will be included. This will depend upon documentation from primary care giver).
- CD4 counts below 300
- viral load greater than 35,000.
- Exclusion criteria (13) and (14) are added because the protocol requires that subjects be on a stable anti-retroviral regime for 3 months prior to study and 2 months on study. These criteria will make it less likely that anti-retroviral therapies will be switched in this subject population who are doing well.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Hospital GCRC
Stony Brook, New York, 11794
About this study
This research is to investigate the nutritional supplement chromium picolinate. The investigators are testing to see how effective this supplement is in treating insulin resistance associated with HIV disease.
Read the detailed description
This study will test the hypothesis that chromium picolinate improves insulin-stimulated glucose uptake by increasing the insulin receptor-mediated tyrosine phosphorylation of insulin receptor substrate-1, resulting in increased association with phosphatidylinositol 3-kinase.
Specific Aim 1 will assess quantitative improvements in insulin-mediated glucose disposal in a placebo-controlled clinical trial of chromium supplementation with 1000mpg (19.2 pmol) of chromium as chromium picolinate, overa two-month course of therapy. The investigators have shown that the insulin resistance (i.e. the inability of insulin to stimulate glucose uptake into peripheral tissues like muscle) in patients with HIV disease is associated with a defect in the insulin-signaling pathway leading from the insulin receptor, through phosphatidylinositol 3-kinase(PI 3-K, Figure 5). A similar defect in intracellular signaling has also been reported in patients with type 2 diabetes mellitus ):15-171. The cellular mechanism of improved insulin sensitivity with chromium supplementation will be determined in Specific Aim 2.
Specific Aim 2 will assess the effect of chromium supplementation on the insulin-stimulated activity of insulin receptor substrate-I-associated phosphatidylinositol 3-kinase in biopsies of muscle and fat tissue. This aim will also test the hypothesis that these physiological effects of chromium are mediated by alterations in the activity of insulin signaling. Understanding this mechanism may facilitate the design of even more effective strategies for improving insulin sensitivity.
- Conditions
- Insulin Resistance
- Being tested
- Chromium Picolinate
- Keywords
- Insulin resistance, HIV disease, chromium picolinate
- Medical subject headings
- Insulin Resistance, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chromium PicolinateDietary supplement
Also called Chromax
Subjects will be asked to take chromium picolinate; 2 tablets per day, 1000 mcg or a placebo for a total of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Chromium Picolinate | Subjects who are HIV+ and insulin resistant Receives: Dietary Supplement: Chromium Picolinate | |
| Placebo | HIV+ and insulin resistant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chromium Picolinate supplementation
Hypothesis that chromium picolinate improved insulin-stimulated glucose uptake by increasing the insulin receptor-mediated tyrosine phosphorylation of insulin receptor substrate-1, resulting in increased association with phosphatidylinositol 3-kinase. There was a significant negative correlation between the fasting glucose levels and the insulin sensitivity.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJun 2005
- Primary completionMay 2010
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Gelato, Stony Brook University
- Investigators
- Marie C Gelato, MD, PhD, Principal investigator, Stony Brook University School of Medicine Dept. Of Medicine/Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006914
- Sponsor's protocol ID
- R21AT002499
- Status last verified
- Dec 2013
- First submitted
- 11 Aug 2011
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stein SA, Mc Nurlan M, Phillips BT, Messina C, Mynarcik D, Gelato M. Chromium Therapy for Insulin Resistance Associated with HIV-Disease. J AIDS Clin Res. 2013 Sep 7;4(9):239. doi: 10.4172/2155-6113.1000239.
PubMed 25346863
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Therapy for Glucose Intolerance in HIV Disease
- ClinicalTrials.gov ID
- NCT02006914
- Acronym / sponsor ID
- R21AT002499
- Conditions
- Insulin Resistance
- Keywords
- Insulin resistance, HIV disease, chromium picolinate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- May 2010 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is to investigate the nutritional supplement chromium picolinate. The investigators are testing to see how effective this supplement is in treating insulin resistance associated with HIV disease.
Detailed description
This study will test the hypothesis that chromium picolinate improves insulin-stimulated glucose uptake by increasing the insulin receptor-mediated tyrosine phosphorylation of insulin receptor substrate-1, resulting in increased association with phosphatidylinositol 3-kinase.
Specific Aim 1 will assess quantitative improvements in insulin-mediated glucose disposal in a placebo-controlled clinical trial of chromium supplementation with 1000mpg (19.2 pmol) of chromium as chromium picolinate, overa two-month course of therapy. The investigators have shown that the insulin resistance (i.e. the inability of insulin to stimulate glucose uptake into peripheral tissues like muscle) in patients with HIV disease is associated with a defect in the insulin-signaling pathway leading from the insulin receptor, through phosphatidylinositol 3-kinase(PI 3-K, Figure 5). A similar defect in intracellular signaling has also been reported in patients with type 2 diabetes mellitus ):15-171. The cellular mechanism of improved insulin sensitivity with chromium supplementation will be determined in Specific Aim 2.
Specific Aim 2 will assess the effect of chromium supplementation on the insulin-stimulated activity of insulin receptor substrate-I-associated phosphatidylinositol 3-kinase in biopsies of muscle and fat tissue. This aim will also test the hypothesis that these physiological effects of chromium are mediated by alterations in the activity of insulin signaling. Understanding this mechanism may facilitate the design of even more effective strategies for improving insulin sensitivity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chromium Picolinate | – | Dietary Supplement: Chromium PicolinateSubjects who are HIV+ and insulin resistant |
| Placebo | – | –HIV+ and insulin resistant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Anyone with a positive diagnosis of HIV disease.
Key inclusion criteria (1 listed)
- Age > 18 years and a diagnosis of HIV+ andlor AlDS made by standard CDC criteria.
Key exclusion criteria (15 listed)
- positive pregnancy test (all women must have a negative pregnancy test before beginning protocol);
- diagnosis of cancer;
- acute illness of any sort, however, patients may be enrolled once they are stable;
- hemoglobin less than 11.0 gldl or hemodynamically unstable;
- creatinine greater than or equal to 1.5 mgldl;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chromium PicolinateAlso: ChromaxSubjects will be asked to take chromium picolinate; 2 tablets per day, 1000 mcg or a placebo for a total of 8 weeks. | Dietary supplement | Chromium Picolinate |
Primary outcome
Chromium Picolinate supplementation
Time frame: 8 weeks
Hypothesis that chromium picolinate improved insulin-stimulated glucose uptake by increasing the insulin receptor-mediated tyrosine phosphorylation of insulin receptor substrate-1, resulting in increased association with phosphatidylinositol 3-kinase. There was a significant negative correlation between the fasting glucose levels and the insulin sensitivity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
- Results publication: PubMed 25346863Stein SA, Mc Nurlan M, Phillips BT, Messina C, Mynarcik D, Gelato M. Chromium Therapy for Insulin Resistance Associated with HIV-Disease. J AIDS Clin Res. 2013 Sep 7;4(9):239. doi: 10.4172/2155-6113.1000239.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie C Gelato, MD, PhD principal investigator
Stony Brook University School of Medicine Dept. Of Medicine/Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance, run by Stony Brook University 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 1 inclusion and 15 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 10 Dec 2013. 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.
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?
Chromium Picolinate supplementation (time frame: 8 weeks). 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 NCT02006914, 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 10 Dec 2013.