Cardiovascular DiseasesPhase 2STRRIDE2NCT00275145
Effects of Resistance and Aerobic Exercise on Cardiovascular Health
A Phase 2 study testing Resistance Training, Aerobic Exercise and Combo in people with Cardiovascular Diseases and Heart Diseases, run by Duke University at 1 site in United States.
Trial summary
This study will investigate the separate and combined effects of aerobic and resistance training on cardiovascular risk factors in overweight men and women with mild to moderate dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Obesity
- What is being tested?
- Resistance Training, Aerobic Exercise and Combo
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Dec 2008
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sedentary (exercises fewer than two times per week)
- Overweight or mildly obese (body mass index [BMI] of 25 to 35 kg/m2) with mild to moderate lipid abnormalities (either LDL cholesterol 130 to 190 mg/dl or HDL cholesterol less than 40 mg/dl for men or 5 less than 45 mg/dl for women)
Who cannot join
- Diabetes
- Hypertension
- Other metabolic or musculoskeletal diseases
- Current use of or intent to diet
- Use of confounding medication
- Overt presence of coronary heart disease
- Unwilling to be randomized to any group
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peripheral Effects of Exercise on Cardiovascular Health (STRRIDE II)
This study will investigate the separate and combined effects of aerobic and resistance training on cardiovascular risk factors in overweight men and women with mild to moderate dyslipidemia.
Read the detailed description
BACKGROUND:
Substantial evidence supports a favorable relationship between cardiovascular fitness, physical activity, and cardiovascular health. In particular, it is well established that increased levels of physical activity result in favorable improvements in lipid and carbohydrate metabolism. There is also evidence that increased physical activity and cardiovascular fitness have beneficial effects on cardiovascular health, independent of the effects on specific cardiovascular risk factors. One hypothesis proposes that the beneficial effects of regular exercise in humans is mediated through peripheral mechanisms, in particular through the chronic adaptations in skeletal muscle to habitual exercise. The exercise exposure required to achieve health benefits is poorly defined and the mechanisms through which these beneficial adaptations occur are poorly understood. This study will investigate the peripheral biological mechanisms through which chronic physical activity alters carbohydrate metabolism and lipid metabolism, resulting in improvements in these parameters of cardiovascular health and fitness.
DESIGN NARRATIVE:
In Studies of a Targeted Risk Reduction Intervention through Defined Exercise II (STRRIDE II), participants will be randomly assigned to one of four exercise training regimens after a 4-month sedentary control period. After an initial ramp period of up to 2 months, participants will be asked to train for 6 months in a given exercise program. The programs differ either in the dose of aerobic exercise or in the mode (e.g., aerobic exercise, resistance exercise, or a combination). Parameters reflecting changes in carbohydrate and lipid metabolism will be studied at an integrative physiologic level and with measurable biological endpoints in peripheral skeletal muscle (capillary surface area). It is proposed that the elucidation of the peripheral mechanisms mediating the favorable responses in carbohydrate and lipid metabolism to chronic physical activity will lead to better understanding of the health benefits conferred by physical activity and cardiovascular fitness. This may also point the way toward better exercise recommendations for clients with significant cardiovascular risk factors. The purpose of this study is to investigate the peripheral biological mechanisms through which chronic physical activity will alter carbohydrate metabolism and lipid metabolism that results in improvement in parameters of cardiovascular health and fitness. The driving hypothesis is that the health benefits derived from habitual exercise are primarily mediated through adaptations occurring in skeletal muscle. The mechanism of change in skeletal muscle differs by the mode of exercise training. It is hypothesized that the health benefits of aerobic exercise are mediated primarily by qualitative changes in skeletal muscles (alterations in exposed capillary surface area in skeletal muscle induced by exercise training) and that the health benefits of resistance exercise are mediated primarily by quantitative changes in skeletal muscles (alterations in fiber area in skeletal muscle induced by exercise training). The investigators will use combination exercise regimens in moderately obese patients with mild to moderate lipid metabolic abnormalities in order to investigate whether induced alterations in skeletal muscle fiber area, metabolic capacity, and capillary surface area account for favorable alterations in insulin sensitivity, glucose metabolism, lipoprotein levels, and lipid metabolism.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity, Hyperlipidemia, Insulin Resistance, Metabolic Syndrome X
- Being tested
- Resistance Training, Aerobic Exercise, Combo, Continued Sedentary lifestyle
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity, Hyperlipidemias, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingBehavioural
Lifting weights 3 times per week; 8 different exercise each time; for each exercise, do three sets = lifting an appropriate weight between 8-12 for each set; rest 45 seconds (at least) between sets
Aerobic ExerciseBehavioural
Exercise at 75% of maximal capacity for approximately 2 hours per week
ComboBehavioural
Lift weights (as described in RT group) and do aerobic exercise (as described in Aerobic group
Continued Sedentary lifestyleBehavioural
No changes
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training | Experimental | 8 months of Resistance Exercise Training Receives: Behavioral: Resistance Training |
| Aerobic Exercise | Experimental | 8 months of Aerobic Exercise Training Receives: Behavioral: Aerobic Exercise |
| Combination RT & AT | Experimental | 8 months of Combined Aerobic and Resistance Exercise Training Receives: Behavioral: Combo |
| Control | Experimental | Control/sedentary intervention Receives: Behavioral: Continued Sedentary lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Cardiometabolic Risk Factors: lipoproteins; Ectopic Fat (Visceral Fat, Liver fat); body composition (fat mass, lean body mass; and Insulin Sensitivity
Measured: Month 0, Month 4, Year 1, and Year 1 plus 2 weeks
Secondary outcomes (1)
Metabolic Syndrome (ATP III defined); Maximal Oxygen consumption; muscle biopsy measures (oxidative enzymes, capillary density, myofiber diameter)
Measured: 0 mths, 4 mths, 1 year and 1 year and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startMay 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- William E. Kraus, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275145
- Sponsor's protocol ID
- Pro00014514
- Other IDs
- R01HL057354, 0438
- Acronym
- STRRIDE2
- Status last verified
- Nov 2011
- First submitted
- 10 Jan 2006
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Jiang R, Collins KA, Huffman KM, Hauser ER, Hubal MJ, Johnson JL, Williams RB, Siegler IC, Kraus WE. Genome-Wide Genetic Analysis of Dropout in a Controlled Exercise Intervention in Sedentary Adults With Overweight or Obesity and Cardiometabolic Disease. Ann Behav Med. 2024 Apr 11;58(5):363-374. doi: 10.1093/abm/kaae011.
PubMed 38489667Collins KA, Fos LB, Ross LM, Slentz CA, Davis PG, Willis LH, Piner LW, Bateman LA, Houmard JA, Kraus WE. Aerobic, Resistance, and Combination Training on Health-Related Quality of Life: The STRRIDE-AT/RT Randomized Trial. Front Sports Act Living. 2021 Feb 11;2:620300. doi: 10.3389/fspor.2020.620300. eCollection 2020.
PubMed 33644749AbouAssi H, Slentz CA, Mikus CR, Tanner CJ, Bateman LA, Willis LH, Shields AT, Piner LW, Penry LE, Kraus EA, Huffman KM, Bales CW, Houmard JA, Kraus WE. The effects of aerobic, resistance, and combination training on insulin sensitivity and secretion in overweight adults from STRRIDE AT/RT: a randomized trial. J Appl Physiol (1985). 2015 Jun 15;118(12):1474-82. doi: 10.1152/japplphysiol.00509.2014.
PubMed 25882384Moker EA, Bateman LA, Kraus WE, Pescatello LS. The relationship between the blood pressure responses to exercise following training and detraining periods. PLoS One. 2014 Sep 10;9(9):e105755. doi: 10.1371/journal.pone.0105755. eCollection 2014.
PubMed 25208075Huffman KM, Koves TR, Hubal MJ, Abouassi H, Beri N, Bateman LA, Stevens RD, Ilkayeva OR, Hoffman EP, Muoio DM, Kraus WE. Metabolite signatures of exercise training in human skeletal muscle relate to mitochondrial remodelling and cardiometabolic fitness. Diabetologia. 2014 Nov;57(11):2282-95. doi: 10.1007/s00125-014-3343-4. Epub 2014 Aug 5.
PubMed 25091629Willis LH, Slentz CA, Bateman LA, Shields AT, Piner LW, Bales CW, Houmard JA, Kraus WE. Effects of aerobic and/or resistance training on body mass and fat mass in overweight or obese adults. J Appl Physiol (1985). 2012 Dec 15;113(12):1831-7. doi: 10.1152/japplphysiol.01370.2011. Epub 2012 Sep 27.
PubMed 23019316Slentz CA, Bateman LA, Willis LH, Shields AT, Tanner CJ, Piner LW, Hawk VH, Muehlbauer MJ, Samsa GP, Nelson RC, Huffman KM, Bales CW, Houmard JA, Kraus WE. Effects of aerobic vs. resistance training on visceral and liver fat stores, liver enzymes, and insulin resistance by HOMA in overweight adults from STRRIDE AT/RT. Am J Physiol Endocrinol Metab. 2011 Nov;301(5):E1033-9. doi: 10.1152/ajpendo.00291.2011. Epub 2011 Aug 16.
PubMed 21846904Bateman LA, Slentz CA, Willis LH, Shields AT, Piner LW, Bales CW, Houmard JA, Kraus WE. Comparison of aerobic versus resistance exercise training effects on metabolic syndrome (from the Studies of a Targeted Risk Reduction Intervention Through Defined Exercise - STRRIDE-AT/RT). Am J Cardiol. 2011 Sep 15;108(6):838-44. doi: 10.1016/j.amjcard.2011.04.037. Epub 2011 Jul 7.
PubMed 21741606
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Effects of Exercise on Cardiovascular Health (STRRIDE II)
- ClinicalTrials.gov ID
- NCT00275145
- Acronym / sponsor ID
- STRRIDE2 / Pro00014514
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity, Hyperlipidemia, Insulin Resistance, Metabolic Syndrome X
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Jan 2006 (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 study will investigate the separate and combined effects of aerobic and resistance training on cardiovascular risk factors in overweight men and women with mild to moderate dyslipidemia.
Detailed description
BACKGROUND:
Substantial evidence supports a favorable relationship between cardiovascular fitness, physical activity, and cardiovascular health. In particular, it is well established that increased levels of physical activity result in favorable improvements in lipid and carbohydrate metabolism. There is also evidence that increased physical activity and cardiovascular fitness have beneficial effects on cardiovascular health, independent of the effects on specific cardiovascular risk factors. One hypothesis proposes that the beneficial effects of regular exercise in humans is mediated through peripheral mechanisms, in particular through the chronic adaptations in skeletal muscle to habitual exercise. The exercise exposure required to achieve health benefits is poorly defined and the mechanisms through which these beneficial adaptations occur are poorly understood. This study will investigate the peripheral biological mechanisms through which chronic physical activity alters carbohydrate metabolism and lipid metabolism, resulting in improvements in these parameters of cardiovascular health and fitness.
DESIGN NARRATIVE:
In Studies of a Targeted Risk Reduction Intervention through Defined Exercise II (STRRIDE II), participants will be randomly assigned to one of four exercise training regimens after a 4-month sedentary control period. After an initial ramp period of up to 2 months, participants will be asked to train for 6 months in a given exercise program. The programs differ either in the dose of aerobic exercise or in the mode (e.g., aerobic exercise, resistance exercise, or a combination). Parameters reflecting changes in carbohydrate and lipid metabolism will be studied at an integrative physiologic level and with measurable biological endpoints in peripheral skeletal muscle (capillary surface area). It is proposed that the elucidation of the peripheral mechanisms mediating the favorable responses in carbohydrate and lipid metabolism to chronic physical activity will lead to better understanding of the health benefits conferred by physical activity and cardiovascular fitness. This may also point the way toward better exercise recommendations for clients with significant cardiovascular risk factors. The purpose of this study is to investigate the peripheral biological mechanisms through which chronic physical activity will alter carbohydrate metabolism and lipid metabolism that results in improvement in parameters of cardiovascular health and fitness. The driving hypothesis is that the health benefits derived from habitual exercise are primarily mediated through adaptations occurring in skeletal muscle. The mechanism of change in skeletal muscle differs by the mode of exercise training. It is hypothesized that the health benefits of aerobic exercise are mediated primarily by qualitative changes in skeletal muscles (alterations in exposed capillary surface area in skeletal muscle induced by exercise training) and that the health benefits of resistance exercise are mediated primarily by quantitative changes in skeletal muscles (alterations in fiber area in skeletal muscle induced by exercise training). The investigators will use combination exercise regimens in moderately obese patients with mild to moderate lipid metabolic abnormalities in order to investigate whether induced alterations in skeletal muscle fiber area, metabolic capacity, and capillary surface area account for favorable alterations in insulin sensitivity, glucose metabolism, lipoprotein levels, and lipid metabolism.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Resistance Training | Experimental | Behavioral: Resistance Training8 months of Resistance Exercise Training |
| Aerobic Exercise | Experimental | Behavioral: Aerobic Exercise8 months of Aerobic Exercise Training |
| Combination RT & AT | Experimental | Behavioral: Combo8 months of Combined Aerobic and Resistance Exercise Training |
| Control | Experimental | Behavioral: Continued Sedentary lifestyleControl/sedentary intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sedentary (exercises fewer than two times per week)
- Overweight or mildly obese (body mass index [BMI] of 25 to 35 kg/m2) with mild to moderate lipid abnormalities (either LDL cholesterol 130 to 190 mg/dl or HDL cholesterol less than 40 mg/dl for men or 5 less than 45 mg/dl for women)
Key exclusion criteria (7 listed)
- Diabetes
- Hypertension
- Other metabolic or musculoskeletal diseases
- Current use of or intent to diet
- Use of confounding medication
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 |
|---|---|---|
| Resistance TrainingLifting weights 3 times per week; 8 different exercise each time; for each exercise, do three sets = lifting an appropriate weight between 8-12 for each set; rest 45 seconds (at least) between sets | Behavioural | Resistance Training |
| Aerobic ExerciseExercise at 75% of maximal capacity for approximately 2 hours per week | Behavioural | Aerobic Exercise |
| ComboLift weights (as described in RT group) and do aerobic exercise (as described in Aerobic group | Behavioural | Combination RT & AT |
| Continued Sedentary lifestyleNo changes | Behavioural | Control |
Primary outcome
Major Cardiometabolic Risk Factors: lipoproteins; Ectopic Fat (Visceral Fat, Liver fat); body composition (fat mass, lean body mass; and Insulin Sensitivity
Time frame: Month 0, Month 4, Year 1, and Year 1 plus 2 weeks
1 secondary outcome
Metabolic Syndrome (ATP III defined); Maximal Oxygen consumption; muscle biopsy measures (oxidative enzymes, capillary density, myofiber diameter)
Time frame: 0 mths, 4 mths, 1 year and 1 year and 2 weeks
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 24 May 2013.
- Derived from this study: PubMed 38489667Jiang R, Collins KA, Huffman KM, Hauser ER, Hubal MJ, Johnson JL, Williams RB, Siegler IC, Kraus WE. Genome-Wide Genetic Analysis of Dropout in a Controlled Exercise Intervention in Sedentary Adults With Overweight or Obesity and Cardiometabolic Disease. Ann Behav Med. 2024 Apr 11;58(5):363-374. doi: 10.1093/abm/kaae011.
- Derived from this study: PubMed 33644749Collins KA, Fos LB, Ross LM, Slentz CA, Davis PG, Willis LH, Piner LW, Bateman LA, Houmard JA, Kraus WE. Aerobic, Resistance, and Combination Training on Health-Related Quality of Life: The STRRIDE-AT/RT Randomized Trial. Front Sports Act Living. 2021 Feb 11;2:620300. doi: 10.3389/fspor.2020.620300. eCollection 2020.
- Derived from this study: PubMed 25882384AbouAssi H, Slentz CA, Mikus CR, Tanner CJ, Bateman LA, Willis LH, Shields AT, Piner LW, Penry LE, Kraus EA, Huffman KM, Bales CW, Houmard JA, Kraus WE. The effects of aerobic, resistance, and combination training on insulin sensitivity and secretion in overweight adults from STRRIDE AT/RT: a randomized trial. J Appl Physiol (1985). 2015 Jun 15;118(12):1474-82. doi: 10.1152/japplphysiol.00509.2014.
- Derived from this study: PubMed 25208075Moker EA, Bateman LA, Kraus WE, Pescatello LS. The relationship between the blood pressure responses to exercise following training and detraining periods. PLoS One. 2014 Sep 10;9(9):e105755. doi: 10.1371/journal.pone.0105755. eCollection 2014.
- Derived from this study: PubMed 25091629Huffman KM, Koves TR, Hubal MJ, Abouassi H, Beri N, Bateman LA, Stevens RD, Ilkayeva OR, Hoffman EP, Muoio DM, Kraus WE. Metabolite signatures of exercise training in human skeletal muscle relate to mitochondrial remodelling and cardiometabolic fitness. Diabetologia. 2014 Nov;57(11):2282-95. doi: 10.1007/s00125-014-3343-4. Epub 2014 Aug 5.
- Derived from this study: PubMed 23019316Willis LH, Slentz CA, Bateman LA, Shields AT, Piner LW, Bales CW, Houmard JA, Kraus WE. Effects of aerobic and/or resistance training on body mass and fat mass in overweight or obese adults. J Appl Physiol (1985). 2012 Dec 15;113(12):1831-7. doi: 10.1152/japplphysiol.01370.2011. Epub 2012 Sep 27.
- Derived from this study: PubMed 21846904Slentz CA, Bateman LA, Willis LH, Shields AT, Tanner CJ, Piner LW, Hawk VH, Muehlbauer MJ, Samsa GP, Nelson RC, Huffman KM, Bales CW, Houmard JA, Kraus WE. Effects of aerobic vs. resistance training on visceral and liver fat stores, liver enzymes, and insulin resistance by HOMA in overweight adults from STRRIDE AT/RT. Am J Physiol Endocrinol Metab. 2011 Nov;301(5):E1033-9. doi: 10.1152/ajpendo.00291.2011. Epub 2011 Aug 16.
- Derived from this study: PubMed 21741606Bateman LA, Slentz CA, Willis LH, Shields AT, Piner LW, Bales CW, Houmard JA, Kraus WE. Comparison of aerobic versus resistance exercise training effects on metabolic syndrome (from the Studies of a Targeted Risk Reduction Intervention Through Defined Exercise - STRRIDE-AT/RT). Am J Cardiol. 2011 Sep 15;108(6):838-44. doi: 10.1016/j.amjcard.2011.04.037. Epub 2011 Jul 7.
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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.
William E. Kraus study chair
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resistance Training, Aerobic Exercise and Combo in people with Cardiovascular Diseases and Heart Diseases, run by Duke 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 2 inclusion and 7 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 24 May 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.
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?
Major Cardiometabolic Risk Factors: lipoproteins; Ectopic Fat (Visceral Fat, Liver fat); body composition (fat mass, lean body mass; and Insulin Sensitivity (time frame: Month 0, Month 4, Year 1, and Year 1 plus 2 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 NCT00275145, which also lists 8 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 24 May 2013.