ObesityNCT02493413
The Stress-release Effects of Exercise in Obese Are Determined by DS14 Score and T-cell Activation Status
An observational study of Obesity and Type D Personality, run by Institute for Preventive Medicine, Trzaska.
Trial summary
The purpose of the study was to analyze negative affectivity (NA) and social inhibition (SI) inquired by DS14 score in type D personality (distressed personality) to the relation of autonomic regulation of heart function (HRV) and immune response (T lymphocyte) among obese patients within coronary heart disease group… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity, Type D Personality, Coronary Heart Disease
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Mar 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 examinees, 14 men of average age 56,3 ± 15,5 years old and 16 women of average age of 53,5. ± 4,2 years old made the owerweight/obese group of chronic (coronary heart disease) patients. Subjects were matched by gender, age, body mass index and had all been regular visitors (patients) of The Institute of Preventive Medicine.
Who may be able to join
- obese people without detectable complications of coronary heart disease
Who cannot join
- Obese patients with angina pectoris, myocardial infarction, valvular heart disease and congestive heart disease had been excluded from the research.
About this study
The purpose of the study was to analyze negative affectivity (NA) and social inhibition (SI) inquired by DS14 score in type D personality (distressed personality) to the relation of autonomic regulation of heart function (HRV) and immune response (T lymphocyte) among obese patients within coronary heart disease group (CHD). As stress is the key psychological activator of the hypothalamic-pituitary-adrenal axis (HPA axis) and therefore an important risk factor for diminished immune competency and prevalence of chronic conditions such as obesity, investigators chose exercise as the stress release intervention, especially as chronic stress may have a role in obesity, related to initiation or exacerbation of the condition. Abnormal regulation of the hypothalamic-pituitary-adrenal axis is additionally associated with chronic inflammatory conditions. Proinflammatory T-lymphocytes are present in visceral adipose tissue and may contribute to local inflammatory cell activation before the appearance of macrophages, suggesting that these cells could play an important role in the initiation and perpetuation of adipose tissue inflammation.
Read the detailed description
This study was performed at The Institute for Preventive Medicine in cooperation with The Institute of Microbiology and Immunology at the Medical Faculty of Ljubljana/University of Ljubljana in a clinical setting as an observational type. In the group of examinees the investigators chose only those obese without detectable complications of coronary heart disease while admitted. Obese patients with angina pectoris, myocardial infarction, valvular heart disease and congestive heart disease had been excluded from the research. Since personality is the major determinant of chronic stress, according to the investigators hypothesis, further division on two global traits Negative affectivity (NA) and Social inhibition (SI) structured by Denollet has been positioned in the study. A total of 30 patients with CHD were divided in two groups. Participants who were obese with high DS14 score matched obese controls with normal DS14 score. In all subjects the investigators also observed white blood cell counts with a detailed lymphocyte analysis using flow cytometry and C-reactive protein (CRP) as the indicator of inflammation. Besides body mass (BM), body mass index (BMI) systolic and diastolic blood pressure (SBP, DBP), heart rate (HR), and heart rate variability (HRV) were measured before and after three months period, while all subjects had been already exercising 4 times weakly (moderate walking of 5km/h) for an hour. Additionally STAIX-1, SWLS and QOLLTI-P questionnaires had been used.
- Conditions
- Obesity, Type D Personality, Coronary Heart Disease
- Keywords
- psychoneuroimmunology, stress, lymphocyte population, personality type, obesity, heart rate variability, awareness
- Medical subject headings
- Obesity, Coronary Disease
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 |
|---|---|---|
| Group A | observational time of three months in the obese group with distressed (type D) personality (high DS 14 score) with moderate aerobic exercise | |
| Group B | observational time of three months in obese group without distressed personality (low DS 14 score) with moderate aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in DS14 Score at 3 Months
Each examines filled in DS14 scale to determine negative affectivity (NA), social inhibition (SI) and Type D personality for early identification of high-risk CHD patients (Denollet, 2005). Subjects rated their personality on a 5-point Likert scale ranging from 0 _ false to 4 _true. The NA and SI scales can be scored as continuous variables (range, 0-28) to assess these personality traits in their own right. A cutoff of 10 on both scales is used to classify subjects as Type D (NA _10 and SI _10).
Measured: baseline and 3 months
Change in STAIX-1 questionnaire score
The STAIX-1 Form is an administered analysis of reported anxiety symptoms. The first subscale measures state anxiety, the second measures trait anxiety.
The range of scores is 20-80, the higher the score indicating greater anxiety.
Measured: baseline and 3 months
Change in Peripheral Human Blood Leucocytes
Peripheral human blood leucocytes were collected by the venipuncture procedure and collected into Vacutainers.Two-parameter analysis was performed to determine the proportion of T cells (CD3+), T helper cells (CD3+CD4+) and cytotoxic T cells (CD3+CD8+). Isotype controls (Becton Dickinson, Mountain View, CA) and a control of viable cells (LIVE/DEAD kit, Molecular Probes, OR) were included. At least 2000 gated cells were analyzed for each test, and signals from two light scatters and four fluorescence parameters were analyzed with the Becton Dickinson Lysis II software.
Measured: baseline and 3 months
Change in Cortisol Levels
The measurement of cortisol in salivary samples accurately reflects levels of physiologically active unbound (free) cortisol in the blood, which diffuses from the blood to saliva.
Measured: baseline and 3 months
Change in Heart Rate variability (HRV)
The investigators chose the combination of Time domain methods and Frequency domain methods to compare variability among groups under physical exercise and within 24 hours.
Measured: baseline and 3 months
Change in SWLS questionnaire score
The Satisfaction With Life Scale (SWLS) is a measure of life satisfaction. Life satisfaction can be assessed specific to a particular domain of life (e.g., work, family) or globally. The SWLS is a global measure of life satisfaction.
Measured: baseline and 3 months
Change in QOLLTI-P questionnaire score
The Quality of Life in Life-Threatening Illness-Patient questionnaire (QOLLTI-P) is a self-administered questionnaire based on the McGill Quality of Life questionnaire (MQOL) with domains added to enhance content validity. Participants were asked to complete a set of above questionnaires prior to immunological assessment and HRV measurement.
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Preventive Medicine, Trzaska
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana
- Responsible party
- Principal investigator, Mateja Hafner M.D., Institute for Preventive Medicine, Trzaska
- Investigators
- Mateja Hafner, M.D., Principal investigator, Institute of Preventive medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493413
- Sponsor's protocol ID
- 001563777
- Status last verified
- Jul 2015
- First submitted
- 1 Jul 2015
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Denollet J. DS14: standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosom Med. 2005 Jan-Feb;67(1):89-97. doi: 10.1097/01.psy.0000149256.81953.49.
PubMed 15673629Suwa A, Shimokawa T. Emerging targets for the treatment of obesity. FEBS J. 2011 Feb;278(4):551. doi: 10.1111/j.1742-4658.2010.07981.x. Epub 2010 Dec 30. No abstract available.
PubMed 21291513Kintscher U, Hartge M, Hess K, Foryst-Ludwig A, Clemenz M, Wabitsch M, Fischer-Posovszky P, Barth TF, Dragun D, Skurk T, Hauner H, Bluher M, Unger T, Wolf AM, Knippschild U, Hombach V, Marx N. T-lymphocyte infiltration in visceral adipose tissue: a primary event in adipose tissue inflammation and the development of obesity-mediated insulin resistance. Arterioscler Thromb Vasc Biol. 2008 Jul;28(7):1304-10. doi: 10.1161/ATVBAHA.108.165100. Epub 2008 Apr 17.
PubMed 18420999Ader R, Cohen N. Behaviorally conditioned immunosuppression. Psychosom Med. 1975 Jul-Aug;37(4):333-40. doi: 10.1097/00006842-197507000-00007.
PubMed 1162023Thayer JF, Ahs F, Fredrikson M, Sollers JJ 3rd, Wager TD. A meta-analysis of heart rate variability and neuroimaging studies: implications for heart rate variability as a marker of stress and health. Neurosci Biobehav Rev. 2012 Feb;36(2):747-56. doi: 10.1016/j.neubiorev.2011.11.009. Epub 2011 Dec 8.
PubMed 22178086Watson D, Pennebaker JW. Health complaints, stress, and distress: exploring the central role of negative affectivity. Psychol Rev. 1989 Apr;96(2):234-54. doi: 10.1037/0033-295x.96.2.234.
PubMed 2710874Denollet J. Negative affectivity and repressive coping: pervasive influence on self-reported mood, health, and coronary-prone behavior. Psychosom Med. 1991 Sep-Oct;53(5):538-56. doi: 10.1097/00006842-199109000-00005.
PubMed 1758940Friedman HS, Booth-Kewley S. Personality, type A behavior, and coronary heart disease: the role of emotional expression. J Pers Soc Psychol. 1987 Oct;53(4):783-92. doi: 10.1037//0022-3514.53.4.783.
PubMed 3681651Gest SD. Behavioral inhibition: stability and associations with adaptation from childhood to early adulthood. J Pers Soc Psychol. 1997 Feb;72(2):467-75. doi: 10.1037//0022-3514.72.2.467.
PubMed 9107012Denollet J, Sys SU, Brutsaert DL. Personality and mortality after myocardial infarction. Psychosom Med. 1995 Nov-Dec;57(6):582-91. doi: 10.1097/00006842-199511000-00011.
PubMed 8600485Denollet J, Sys SU, Stroobant N, Rombouts H, Gillebert TC, Brutsaert DL. Personality as independent predictor of long-term mortality in patients with coronary heart disease. Lancet. 1996 Feb 17;347(8999):417-21. doi: 10.1016/s0140-6736(96)90007-0.
PubMed 8618481Ferguson E, Ward JW, Skatova A, Cassaday HJ, Bibby PA, Lawrence C. Health specific traits beyond the Five Factor Model, cognitive processes and trait expression: replies to Watson (2012), Matthews (2012) and Haslam, Jetten, Reynolds, and Reicher (2012). Health Psychol Rev. 2013 May;7(Suppl 1):S85-S103. doi: 10.1080/17437199.2012.701061. Epub 2013 May 28.
PubMed 23772232Piestrzeniewicz K, Luczak K, Lelonek M, Wranicz JK, Goch JH. Obesity and heart rate variability in men with myocardial infarction. Cardiol J. 2008;15(1):43-9.
PubMed 18651384Lee DC, Pate RR, Lavie CJ, Sui X, Church TS, Blair SN. Leisure-time running reduces all-cause and cardiovascular mortality risk. J Am Coll Cardiol. 2014 Aug 5;64(5):472-81. doi: 10.1016/j.jacc.2014.04.058.
PubMed 25082581Thayer JF, Sternberg E. Beyond heart rate variability: vagal regulation of allostatic systems. Ann N Y Acad Sci. 2006 Nov;1088:361-72. doi: 10.1196/annals.1366.014.
PubMed 17192580
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Stress-release Effects of Exercise in Obese Are Determined by DS14 Score and T-cell Activation Status
- ClinicalTrials.gov ID
- NCT02493413
- Acronym / sponsor ID
- 001563777
- Conditions
- Obesity, Type D Personality, Coronary Heart Disease
- Keywords
- psychoneuroimmunology, stress, lymphocyte population, personality type, obesity, heart rate variability, awareness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institute for Preventive Medicine, TrzaskaUniversity, hospital or other
- Collaborators
- University of Ljubljana
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 Jul 2015 (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 purpose of the study was to analyze negative affectivity (NA) and social inhibition (SI) inquired by DS14 score in type D personality (distressed personality) to the relation of autonomic regulation of heart function (HRV) and immune response (T lymphocyte) among obese patients within coronary heart disease group (CHD). As stress is the key psychological activator of the hypothalamic-pituitary-adrenal axis (HPA axis) and therefore an important risk factor for diminished immune competency and prevalence of chronic conditions such as obesity, investigators chose exercise as the stress release intervention, especially as chronic stress may have a role in obesity, related to initiation or exacerbation of the condition. Abnormal regulation of the hypothalamic-pituitary-adrenal axis is additionally associated with chronic inflammatory conditions. Proinflammatory T-lymphocytes are present in visceral adipose tissue and may contribute to local inflammatory cell activation before the appearance of macrophages, suggesting that these cells could play an important role in the initiation and perpetuation of adipose tissue inflammation.
Detailed description
This study was performed at The Institute for Preventive Medicine in cooperation with The Institute of Microbiology and Immunology at the Medical Faculty of Ljubljana/University of Ljubljana in a clinical setting as an observational type. In the group of examinees the investigators chose only those obese without detectable complications of coronary heart disease while admitted. Obese patients with angina pectoris, myocardial infarction, valvular heart disease and congestive heart disease had been excluded from the research. Since personality is the major determinant of chronic stress, according to the investigators hypothesis, further division on two global traits Negative affectivity (NA) and Social inhibition (SI) structured by Denollet has been positioned in the study. A total of 30 patients with CHD were divided in two groups. Participants who were obese with high DS14 score matched obese controls with normal DS14 score. In all subjects the investigators also observed white blood cell counts with a detailed lymphocyte analysis using flow cytometry and C-reactive protein (CRP) as the indicator of inflammation. Besides body mass (BM), body mass index (BMI) systolic and diastolic blood pressure (SBP, DBP), heart rate (HR), and heart rate variability (HRV) were measured before and after three months period, while all subjects had been already exercising 4 times weakly (moderate walking of 5km/h) for an hour. Additionally STAIX-1, SWLS and QOLLTI-P questionnaires had been used.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –observational time of three months in the obese group with distressed (type D) personality (high DS 14 score) with moderate aerobic exercise |
| Group B | – | –observational time of three months in obese group without distressed personality (low DS 14 score) with moderate aerobic exercise |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 examinees, 14 men of average age 56,3 ± 15,5 years old and 16 women of average age of 53,5. ± 4,2 years old made the owerweight/obese group of chronic (coronary heart disease) patients. Subjects were matched by gender, age, body mass index and had all been regular visitors (patients) of The Institute of Preventive Medicine.
Key inclusion criteria (1 listed)
- obese people without detectable complications of coronary heart disease
Key exclusion criteria (1 listed)
- Obese patients with angina pectoris, myocardial infarction, valvular heart disease and congestive heart disease had been excluded from the research.
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
Change from Baseline in DS14 Score at 3 Months
Time frame: baseline and 3 months
Each examines filled in DS14 scale to determine negative affectivity (NA), social inhibition (SI) and Type D personality for early identification of high-risk CHD patients (Denollet, 2005). Subjects rated their personality on a 5-point Likert scale ranging from 0 _ false to 4 _true. The NA and SI scales can be scored as continuous variables (range, 0-28) to assess these personality traits in their own right. A cutoff of 10 on both scales is used to classify subjects as Type D (NA _10 and SI _10).
Change in STAIX-1 questionnaire score
Time frame: baseline and 3 months
The STAIX-1 Form is an administered analysis of reported anxiety symptoms. The first subscale measures state anxiety, the second measures trait anxiety. The range of scores is 20-80, the higher the score indicating greater anxiety.
Change in Peripheral Human Blood Leucocytes
Time frame: baseline and 3 months
Peripheral human blood leucocytes were collected by the venipuncture procedure and collected into Vacutainers.Two-parameter analysis was performed to determine the proportion of T cells (CD3+), T helper cells (CD3+CD4+) and cytotoxic T cells (CD3+CD8+). Isotype controls (Becton Dickinson, Mountain View, CA) and a control of viable cells (LIVE/DEAD kit, Molecular Probes, OR) were included. At least 2000 gated cells were analyzed for each test, and signals from two light scatters and four fluorescence parameters were analyzed with the Becton Dickinson Lysis II software.
Change in Cortisol Levels
Time frame: baseline and 3 months
The measurement of cortisol in salivary samples accurately reflects levels of physiologically active unbound (free) cortisol in the blood, which diffuses from the blood to saliva.
Change in Heart Rate variability (HRV)
Time frame: baseline and 3 months
The investigators chose the combination of Time domain methods and Frequency domain methods to compare variability among groups under physical exercise and within 24 hours.
Change in SWLS questionnaire score
Time frame: baseline and 3 months
The Satisfaction With Life Scale (SWLS) is a measure of life satisfaction. Life satisfaction can be assessed specific to a particular domain of life (e.g., work, family) or globally. The SWLS is a global measure of life satisfaction.
Change in QOLLTI-P questionnaire score
Time frame: baseline and 3 months
The Quality of Life in Life-Threatening Illness-Patient questionnaire (QOLLTI-P) is a self-administered questionnaire based on the McGill Quality of Life questionnaire (MQOL) with domains added to enhance content validity. Participants were asked to complete a set of above questionnaires prior to immunological assessment and HRV measurement.
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 9 Jul 2015.
- Background: PubMed 15673629Denollet J. DS14: standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosom Med. 2005 Jan-Feb;67(1):89-97. doi: 10.1097/01.psy.0000149256.81953.49.
- Background: PubMed 21291513Suwa A, Shimokawa T. Emerging targets for the treatment of obesity. FEBS J. 2011 Feb;278(4):551. doi: 10.1111/j.1742-4658.2010.07981.x. Epub 2010 Dec 30. No abstract available.
- Background: PubMed 18420999Kintscher U, Hartge M, Hess K, Foryst-Ludwig A, Clemenz M, Wabitsch M, Fischer-Posovszky P, Barth TF, Dragun D, Skurk T, Hauner H, Bluher M, Unger T, Wolf AM, Knippschild U, Hombach V, Marx N. T-lymphocyte infiltration in visceral adipose tissue: a primary event in adipose tissue inflammation and the development of obesity-mediated insulin resistance. Arterioscler Thromb Vasc Biol. 2008 Jul;28(7):1304-10. doi: 10.1161/ATVBAHA.108.165100. Epub 2008 Apr 17.
- Background: PubMed 1162023Ader R, Cohen N. Behaviorally conditioned immunosuppression. Psychosom Med. 1975 Jul-Aug;37(4):333-40. doi: 10.1097/00006842-197507000-00007.
- Background: PubMed 22178086Thayer JF, Ahs F, Fredrikson M, Sollers JJ 3rd, Wager TD. A meta-analysis of heart rate variability and neuroimaging studies: implications for heart rate variability as a marker of stress and health. Neurosci Biobehav Rev. 2012 Feb;36(2):747-56. doi: 10.1016/j.neubiorev.2011.11.009. Epub 2011 Dec 8.
- Background: PubMed 2710874Watson D, Pennebaker JW. Health complaints, stress, and distress: exploring the central role of negative affectivity. Psychol Rev. 1989 Apr;96(2):234-54. doi: 10.1037/0033-295x.96.2.234.
- Background: PubMed 1758940Denollet J. Negative affectivity and repressive coping: pervasive influence on self-reported mood, health, and coronary-prone behavior. Psychosom Med. 1991 Sep-Oct;53(5):538-56. doi: 10.1097/00006842-199109000-00005.
- Background: PubMed 3681651Friedman HS, Booth-Kewley S. Personality, type A behavior, and coronary heart disease: the role of emotional expression. J Pers Soc Psychol. 1987 Oct;53(4):783-92. doi: 10.1037//0022-3514.53.4.783.
- Background: PubMed 9107012Gest SD. Behavioral inhibition: stability and associations with adaptation from childhood to early adulthood. J Pers Soc Psychol. 1997 Feb;72(2):467-75. doi: 10.1037//0022-3514.72.2.467.
- Background: PubMed 8600485Denollet J, Sys SU, Brutsaert DL. Personality and mortality after myocardial infarction. Psychosom Med. 1995 Nov-Dec;57(6):582-91. doi: 10.1097/00006842-199511000-00011.
- Background: PubMed 8618481Denollet J, Sys SU, Stroobant N, Rombouts H, Gillebert TC, Brutsaert DL. Personality as independent predictor of long-term mortality in patients with coronary heart disease. Lancet. 1996 Feb 17;347(8999):417-21. doi: 10.1016/s0140-6736(96)90007-0.
- Background: PubMed 23772232Ferguson E, Ward JW, Skatova A, Cassaday HJ, Bibby PA, Lawrence C. Health specific traits beyond the Five Factor Model, cognitive processes and trait expression: replies to Watson (2012), Matthews (2012) and Haslam, Jetten, Reynolds, and Reicher (2012). Health Psychol Rev. 2013 May;7(Suppl 1):S85-S103. doi: 10.1080/17437199.2012.701061. Epub 2013 May 28.
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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.
Mateja Hafner, M.D. principal investigator
Institute of Preventive medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Type D Personality, run by Institute for Preventive Medicine, Trzaska.
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 1 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 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from Baseline in DS14 Score at 3 Months (time frame: baseline and 3 months). The study lists 7 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 NCT02493413, which also lists 22 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 9 Jul 2015.