HIV InfectionsNCT01098045
HIV Fat Redistribution and the Evaluation of Brown Fat
An observational study of HIV Infections, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The specific aims of this study are to determine whether HIV-infected patients with significant fat redistribution and ectopic fat accumulation have increased brown adipose tissue using 18F-FDG Positron Emission Tomography techniques. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Aug 2015
- 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 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: HIV infected patients with fat redistribution and non HIV controls
Who may be able to join
- No history of HIV infection
- Age ≥ 20 and ≤ 60 years of age
- BMI measurement between 18-29.9 kg/m2
Who cannot join
- Hemoglobin <10.0 g/dL.
- Diabetes or on medications for diabetes
- Abnormal thyroid function.
- Therapy with medications such as beta blockers, alpha-blockers, sympatholytic drugs
- Chronic adrenergic drug use (>3 months) and benzodiazepine use.
- Therapy with glucocorticoid (oral and inhaled), growth hormone or other anabolic agents currently or within the past 3 months
- Current substance abuse, including alcohol, cocaine and/or heroin
- Any history of serious or chronic diseases -
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: FDG/PET Imaging for the Assessment of Brown Adipose Tissue in HIV Lipodystrophy
The specific aims of this study are to determine whether HIV-infected patients with significant fat redistribution and ectopic fat accumulation have increased brown adipose tissue using 18F-FDG Positron Emission Tomography techniques.
Recent studies suggest down regulation of Dicer, a major component of miRNA has an important role in the differentiation and function of brown and white adipose tissue and may contribute to lipodystrophy. Therefore we will expand on recent research in this area by recruiting HIV-infected men with lipodystrophy. We will perform subcutaneous fat biopsies of the dorsocervical and abdominal fat in a subset of HIV-infected and non-HIV-infected men in order to explore further the question of down regulation of Dicer and its implication on metabolic abnormalities in this population.
Read the detailed description
Among individuals infected with HIV, highly active antiretroviral therapy has reduced the incidence of morbidity and mortality however, despite recent improvements in newer antiretrovirals patients continue to exhibit secondary effects related to body composition such as lipoatrophy of the periphery, increased adiposity of the trunk and lipomatosis, especially of the dorsocervical spine. Changes in body composition have been reported in 40-50% of HIV-infected patients. Several studies have shown that antiretroviral therapy contributes to changes in body composition and is coupled with increased dyslipidemia, insulin resistance and diabetes.
Accumulation of fat over the dorsocervical spine, or "buffalo" has been reported in 2% to 13% of HIV-infected patients. Enlargement of adipose tissue in the dorsocervical region involves subcutaneous fat and is therefore unique to fat accumulation of the abdominal area. Guallar et al. examined dorsocervical adipose tissue after surgical removal and found that adipose tissue in this area showed substantial levels of the marker gene of brown fat, uncoupling protein 1 (UCP-1) suggesting there may be brown adipose tissue (BAT) in HIV infected individuals with lipomatosis of the dorsocervical spine. Until recently, BAT was known to be present in rodents throughout their lifetime and was thought to be present in humans only during infancy and early childhood. However, recent studies using 18F-FDG PET-CT have confirmed the presence of BAT in adults. Brown adipose tissue is known to affect whole-body metabolism and may be related to insulin sensitivity as well as susceptibility to weight gain.
Using 18F-FDG PET techniques, our group has evaluated HIV-infected subjects with lipoatrophy and noted there was significantly increased glucose uptake into subcutaneous tissue which may suggest presence of BAT in HIV-infected patients. However our previous study did not specifically examine areas of BAT in the subjects. Therefore, using 18F-FDG PET-CT in addition to fat biopsies we propose to explore the presence of BAT in fat depots among HIV-infected patients with fat redistribution, focusing specifically in the cervical area.
Also, as recent studies suggest down regulation of Dicer, a major component of miRNA has an important role in the differentiation and function of brown and white adipose tissue and may contribute to lipodystrophy. We will perform subcutaneous fat biopsies of the dorsocervical and abdominal fat in a subset of HIV-infected and non-HIV-infected men in order to explore further the question of down regulation of Dicer and its implication on metabolic abnormalities in this population.
- Conditions
- HIV Infections
- Keywords
- HIV, fat redistribution, brown adipose tissue, PET
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV-infection with fat redistribution (lipoatrophy) | 1. Evidence of HIV infection 2. Age ≥ 20 and ≤ 60 years of age 3. BMI measurement between 18-24 kg/m2 4. HIV positive, on a stable HAART treatment regimen (including an NRTI) for > 12 months 5. No evidence of fat redistribution rated by the investigator. | |
| Healthy controls | 1. No history of HIV infection 2. Age ≥ 20 and ≤ 60 years of age 3. BMI measurement between 18-29.9 kg/m2 | |
| HIV-infected with fat redistribution (lipohypertrophy) | 1. Evidence of HIV infection 2. Age ≥ 20 and ≤ 60 years of age 3. BMI measurement between 25-29.9 kg/m2 4. HIV positive, on a stable HAART treatment regimen (including an NRTI) for > 12 months 5. Evidence of significant fat redistribution rated by the investigator, including 1) significant fat atrophy of the face, arms or legs, and 2) significant increase in fat accumulation of the neck. | |
| Dicer Cohort | 30 men [HV-infected with fat redistribution (n = 10), HIV-infected without fat redistribution (n=10), and healthy controls (n= 10)] will be recruited for this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brown Fat
Brown Fat will be assessed by PET FDG
Measured: Baseline
Secondary outcomes (5)
UCP-1
UCP-1 will be analyzed from tissue collected from a fat biopsy of dorsocervical spine fat accumulation.
Measured: Baseline
Indirect Calorimetry
Indirect Calorimetry will be performed to measure resting energy expenditure
Measured: Baseline
Anthropometrics
Anthropometric measurements of waist to hip ratio, leg circumference, arm circumference and neck circumference will be performed using a standardized technique.
Measured: Baseline
Glucose tolerance
A baseline glucose level will be obtained and then patients will consume a 75g glucose beverage. Subjects must complete the beverage within 5-10 minutes. Subsequently, blood glucose at +30, +60, +90, and +120 minutes, insulin levels will be assessed at baseline and +120 minutes. Glucose tolerance will be calculated by insulin area under the curve in response to OGTT.
Measured: Baseline
miRNAs
A baseline miRNA profile will be assessed and subsequent pathways
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Steven K. Grinspoon, MD, Massachusetts General Hospital
- Investigators
- Steven Grinspoon, MD, Principal investigator, Massachusetts General HospitalMartin Torriani, MD, Study director, Massachusetts General Hopsital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098045
- Sponsor's protocol ID
- 2009P-001836
- Status last verified
- Aug 2021
- First submitted
- 25 Mar 2010
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Mallon PW, Miller J, Cooper DA, Carr A. Prospective evaluation of the effects of antiretroviral therapy on body composition in HIV-1-infected men starting therapy. AIDS. 2003 May 2;17(7):971-9. doi: 10.1097/00002030-200305020-00005.
PubMed 12700446Bernasconi E, Boubaker K, Junghans C, Flepp M, Furrer HJ, Haensel A, Hirschel B, Boggian K, Chave JP, Opravil M, Weber R, Rickenbach M, Telenti A; Swiss HIV Cohort Study. Abnormalities of body fat distribution in HIV-infected persons treated with antiretroviral drugs: The Swiss HIV Cohort Study. J Acquir Immune Defic Syndr. 2002 Sep 1;31(1):50-5. doi: 10.1097/00126334-200209010-00007.
PubMed 12352150Lichtenstein KA, Ward DJ, Moorman AC, Delaney KM, Young B, Palella FJ Jr, Rhodes PH, Wood KC, Holmberg SD; HIV Outpatient Study Investigators. Clinical assessment of HIV-associated lipodystrophy in an ambulatory population. AIDS. 2001 Jul 27;15(11):1389-98. doi: 10.1097/00002030-200107270-00008.
PubMed 11504960Miller J, Carr A, Emery S, Law M, Mallal S, Baker D, Smith D, Kaldor J, Cooper DA. HIV lipodystrophy: prevalence, severity and correlates of risk in Australia. HIV Med. 2003 Jul;4(3):293-301. doi: 10.1046/j.1468-1293.2003.00159.x.
PubMed 12859330Friis-Moller N, Weber R, Reiss P, Thiebaut R, Kirk O, d'Arminio Monforte A, Pradier C, Morfeldt L, Mateu S, Law M, El-Sadr W, De Wit S, Sabin CA, Phillips AN, Lundgren JD; DAD study group. Cardiovascular disease risk factors in HIV patients--association with antiretroviral therapy. Results from the DAD study. AIDS. 2003 May 23;17(8):1179-93. doi: 10.1097/01.aids.0000060358.78202.c1.
PubMed 12819520Riddler SA, Smit E, Cole SR, Li R, Chmiel JS, Dobs A, Palella F, Visscher B, Evans R, Kingsley LA. Impact of HIV infection and HAART on serum lipids in men. JAMA. 2003 Jun 11;289(22):2978-82. doi: 10.1001/jama.289.22.2978.
PubMed 12799406Hadigan C, Meigs JB, Corcoran C, Rietschel P, Piecuch S, Basgoz N, Davis B, Sax P, Stanley T, Wilson PW, D'Agostino RB, Grinspoon S. Metabolic abnormalities and cardiovascular disease risk factors in adults with human immunodeficiency virus infection and lipodystrophy. Clin Infect Dis. 2001 Jan;32(1):130-9. doi: 10.1086/317541. Epub 2000 Dec 15.
PubMed 11118392Srinivasa S, Torriani M, Fitch KV, Maehler P, Iyengar S, Feldpausch M, Cypess AM, Grinspoon SK. Brief Report: Adipogenic Expression of Brown Fat Genes in HIV and HIV-Related Parameters. J Acquir Immune Defic Syndr. 2019 Dec 15;82(5):491-495. doi: 10.1097/QAI.0000000000002180.
PubMed 31714428Torriani M, Srinivasa S, Fitch KV, Thomou T, Wong K, Petrow E, Kahn CR, Cypess AM, Grinspoon SK. Dysfunctional Subcutaneous Fat With Reduced Dicer and Brown Adipose Tissue Gene Expression in HIV-Infected Patients. J Clin Endocrinol Metab. 2016 Mar;101(3):1225-34. doi: 10.1210/jc.2015-3993. Epub 2016 Jan 12.
PubMed 26756119Torriani M, Zanni MV, Fitch K, Stavrou E, Bredella MA, Lim R, Cypess AM, Grinspoon S. Increased FDG uptake in association with reduced extremity fat in HIV patients. Antivir Ther. 2013;18(2):243-8. doi: 10.3851/IMP2420. Epub 2012 Oct 5.
PubMed 23041595
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FDG/PET Imaging for the Assessment of Brown Adipose Tissue in HIV Lipodystrophy
- ClinicalTrials.gov ID
- NCT01098045
- Acronym / sponsor ID
- 2009P-001836
- Conditions
- HIV Infections
- Keywords
- HIV, fat redistribution, brown adipose tissue, PET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- Mar 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Apr 2010 (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.
The specific aims of this study are to determine whether HIV-infected patients with significant fat redistribution and ectopic fat accumulation have increased brown adipose tissue using 18F-FDG Positron Emission Tomography techniques.
Recent studies suggest down regulation of Dicer, a major component of miRNA has an important role in the differentiation and function of brown and white adipose tissue and may contribute to lipodystrophy. Therefore we will expand on recent research in this area by recruiting HIV-infected men with lipodystrophy. We will perform subcutaneous fat biopsies of the dorsocervical and abdominal fat in a subset of HIV-infected and non-HIV-infected men in order to explore further the question of down regulation of Dicer and its implication on metabolic abnormalities in this population.
Detailed description
Among individuals infected with HIV, highly active antiretroviral therapy has reduced the incidence of morbidity and mortality however, despite recent improvements in newer antiretrovirals patients continue to exhibit secondary effects related to body composition such as lipoatrophy of the periphery, increased adiposity of the trunk and lipomatosis, especially of the dorsocervical spine. Changes in body composition have been reported in 40-50% of HIV-infected patients. Several studies have shown that antiretroviral therapy contributes to changes in body composition and is coupled with increased dyslipidemia, insulin resistance and diabetes.
Accumulation of fat over the dorsocervical spine, or "buffalo" has been reported in 2% to 13% of HIV-infected patients. Enlargement of adipose tissue in the dorsocervical region involves subcutaneous fat and is therefore unique to fat accumulation of the abdominal area. Guallar et al. examined dorsocervical adipose tissue after surgical removal and found that adipose tissue in this area showed substantial levels of the marker gene of brown fat, uncoupling protein 1 (UCP-1) suggesting there may be brown adipose tissue (BAT) in HIV infected individuals with lipomatosis of the dorsocervical spine. Until recently, BAT was known to be present in rodents throughout their lifetime and was thought to be present in humans only during infancy and early childhood. However, recent studies using 18F-FDG PET-CT have confirmed the presence of BAT in adults. Brown adipose tissue is known to affect whole-body metabolism and may be related to insulin sensitivity as well as susceptibility to weight gain.
Using 18F-FDG PET techniques, our group has evaluated HIV-infected subjects with lipoatrophy and noted there was significantly increased glucose uptake into subcutaneous tissue which may suggest presence of BAT in HIV-infected patients. However our previous study did not specifically examine areas of BAT in the subjects. Therefore, using 18F-FDG PET-CT in addition to fat biopsies we propose to explore the presence of BAT in fat depots among HIV-infected patients with fat redistribution, focusing specifically in the cervical area.
Also, as recent studies suggest down regulation of Dicer, a major component of miRNA has an important role in the differentiation and function of brown and white adipose tissue and may contribute to lipodystrophy. We will perform subcutaneous fat biopsies of the dorsocervical and abdominal fat in a subset of HIV-infected and non-HIV-infected men in order to explore further the question of down regulation of Dicer and its implication on metabolic abnormalities in this population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV-infection with fat redistribution (lipoatrophy) | – | –1. Evidence of HIV infection 2. Age ≥ 20 and ≤ 60 years of age 3. BMI measurement between 18-24 kg/m2 4. HIV positive, on a stable HAART treatment regimen (including an NRTI) for > 12 months 5. No evidence of fat redistribution rated by the investigator. |
| Healthy controls | – | –1. No history of HIV infection 2. Age ≥ 20 and ≤ 60 years of age 3. BMI measurement between 18-29.9 kg/m2 |
| HIV-infected with fat redistribution (lipohypertrophy) | – | –1. Evidence of HIV infection 2. Age ≥ 20 and ≤ 60 years of age 3. BMI measurement between 25-29.9 kg/m2 4. HIV positive, on a stable HAART treatment regimen (including an NRTI) for > 12 months 5. Evidence of significant fat redistribution rated by the investigator, including 1) significant fat atrophy of the face, arms or legs, and 2) significant increase in fat accumulation of the neck. |
| Dicer Cohort | – | –30 men [HV-infected with fat redistribution (n = 10), HIV-infected without fat redistribution (n=10), and healthy controls (n= 10)] will be recruited for this group. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- HIV infected patients with fat redistribution and non HIV controls
Key inclusion criteria (3 listed)
- No history of HIV infection
- Age ≥ 20 and ≤ 60 years of age
- BMI measurement between 18-29.9 kg/m2
Key exclusion criteria (8 listed)
- Hemoglobin <10.0 g/dL.
- Diabetes or on medications for diabetes
- Abnormal thyroid function.
- Therapy with medications such as beta blockers, alpha-blockers, sympatholytic drugs
- Chronic adrenergic drug use (>3 months) and benzodiazepine use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brown Fat
Time frame: Baseline
Brown Fat will be assessed by PET FDG
5 secondary outcomes
UCP-1
Time frame: Baseline
Indirect Calorimetry
Time frame: Baseline
Anthropometrics
Time frame: Baseline
Glucose tolerance
Time frame: Baseline
miRNAs
Time frame: Baseline
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 16 Aug 2021.
- Background: PubMed 12700446Mallon PW, Miller J, Cooper DA, Carr A. Prospective evaluation of the effects of antiretroviral therapy on body composition in HIV-1-infected men starting therapy. AIDS. 2003 May 2;17(7):971-9. doi: 10.1097/00002030-200305020-00005.
- Background: PubMed 12352150Bernasconi E, Boubaker K, Junghans C, Flepp M, Furrer HJ, Haensel A, Hirschel B, Boggian K, Chave JP, Opravil M, Weber R, Rickenbach M, Telenti A; Swiss HIV Cohort Study. Abnormalities of body fat distribution in HIV-infected persons treated with antiretroviral drugs: The Swiss HIV Cohort Study. J Acquir Immune Defic Syndr. 2002 Sep 1;31(1):50-5. doi: 10.1097/00126334-200209010-00007.
- Background: PubMed 11504960Lichtenstein KA, Ward DJ, Moorman AC, Delaney KM, Young B, Palella FJ Jr, Rhodes PH, Wood KC, Holmberg SD; HIV Outpatient Study Investigators. Clinical assessment of HIV-associated lipodystrophy in an ambulatory population. AIDS. 2001 Jul 27;15(11):1389-98. doi: 10.1097/00002030-200107270-00008.
- Background: PubMed 12859330Miller J, Carr A, Emery S, Law M, Mallal S, Baker D, Smith D, Kaldor J, Cooper DA. HIV lipodystrophy: prevalence, severity and correlates of risk in Australia. HIV Med. 2003 Jul;4(3):293-301. doi: 10.1046/j.1468-1293.2003.00159.x.
- Background: PubMed 12819520Friis-Moller N, Weber R, Reiss P, Thiebaut R, Kirk O, d'Arminio Monforte A, Pradier C, Morfeldt L, Mateu S, Law M, El-Sadr W, De Wit S, Sabin CA, Phillips AN, Lundgren JD; DAD study group. Cardiovascular disease risk factors in HIV patients--association with antiretroviral therapy. Results from the DAD study. AIDS. 2003 May 23;17(8):1179-93. doi: 10.1097/01.aids.0000060358.78202.c1.
- Background: PubMed 12799406Riddler SA, Smit E, Cole SR, Li R, Chmiel JS, Dobs A, Palella F, Visscher B, Evans R, Kingsley LA. Impact of HIV infection and HAART on serum lipids in men. JAMA. 2003 Jun 11;289(22):2978-82. doi: 10.1001/jama.289.22.2978.
- Background: PubMed 11118392Hadigan C, Meigs JB, Corcoran C, Rietschel P, Piecuch S, Basgoz N, Davis B, Sax P, Stanley T, Wilson PW, D'Agostino RB, Grinspoon S. Metabolic abnormalities and cardiovascular disease risk factors in adults with human immunodeficiency virus infection and lipodystrophy. Clin Infect Dis. 2001 Jan;32(1):130-9. doi: 10.1086/317541. Epub 2000 Dec 15.
- Derived from this study: PubMed 31714428Srinivasa S, Torriani M, Fitch KV, Maehler P, Iyengar S, Feldpausch M, Cypess AM, Grinspoon SK. Brief Report: Adipogenic Expression of Brown Fat Genes in HIV and HIV-Related Parameters. J Acquir Immune Defic Syndr. 2019 Dec 15;82(5):491-495. doi: 10.1097/QAI.0000000000002180.
- Derived from this study: PubMed 26756119Torriani M, Srinivasa S, Fitch KV, Thomou T, Wong K, Petrow E, Kahn CR, Cypess AM, Grinspoon SK. Dysfunctional Subcutaneous Fat With Reduced Dicer and Brown Adipose Tissue Gene Expression in HIV-Infected Patients. J Clin Endocrinol Metab. 2016 Mar;101(3):1225-34. doi: 10.1210/jc.2015-3993. Epub 2016 Jan 12.
- Derived from this study: PubMed 23041595Torriani M, Zanni MV, Fitch K, Stavrou E, Bredella MA, Lim R, Cypess AM, Grinspoon S. Increased FDG uptake in association with reduced extremity fat in HIV patients. Antivir Ther. 2013;18(2):243-8. doi: 10.3851/IMP2420. Epub 2012 Oct 5.
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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.
Steven Grinspoon, MD principal investigator
Massachusetts General Hospital
Martin Torriani, MD study director
Massachusetts General Hopsital
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 HIV Infections, run by Massachusetts General 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 3 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 16 Aug 2021. 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?
Brown Fat (time frame: Baseline). 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 NCT01098045, which also lists 10 linked publications.
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 16 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.