Pre-diabetesISAICNCT01286922
The Insulin Sensitivity Using Aerobic Interval Conditioning
A study testing Behavioral: exercise in people with Pre-diabetes, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The Insulin Sensitivity using Aerobic Interval Conditioning (ISAIC) trial will compare traditional aerobic training (AER) to interval training (INT) in sedentary, overweight/obese men at risk for pre-diabetes. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Behavioral: exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Feb 2012
- Phase
- Interventional
- 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 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 30 to 60 years, inclusive
- BMI greater than or equal to 25 - less than or equal to 35 kg/m2
- Waist circumference >38"; Waist-to-Hip Ratio >0.95 Sedentary Lifestvle
- Not physically active greater than or equal to 3 days/week-l for 20 min each time for the previous 6 months,
- Not participating in regular resistance exercise
Who cannot join
- Resting blood pressure greater than or equal to 160/100 mm Hg
- Triglycerides greater than or equal to 500 mg/dL
- Factors that may limit adherence to intervention or affect conduct of the trial such as lack of time, amount of travel, and/or work or family stressors
- Unable or willing to communicate with staff, to provide written informed consent, or accept the randomized assignment
- Failure to complete behavioral run-in and baseline testing
- Hospitalization for depression in the last 6 months
Show all 28Show fewer
- Not physically capable of performing the exercise required of the study protocols
- Consuming >14 alcoholic beverages per week
- Plans to be away >4 weeks in the next 6 months
- Lack of support from primary health care provider or family members
- Signficant weight loss in the past year (>20 kg) or current use of weight loss medications
- Current diagnsis of schizophrenia, or other psychotic disorders, or bipolar disorder
- Another member of household is a participant or staff member of the study.
- History of bariatric surgery within last 3 years,
- Other temporary intervening event, such as sick spouse, bereavement, or recent move.
- Other medical, psychiatric, or behavioral limitations that in the view of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.
- Underlying diseases or conditions likely to limit lifespan and/or affect the safety of the intervention
- Cancers requiring treatment in the past 5 years, unless prognosis is excellent.
- Self-report HIV or tuberculosis.
- History or evidence of serious arrhythmias, cardiomyopathy, congestive heart failure, aortic aneurysm, or heart transplantation.
- Renal disease: currently receiving dialysis.
- Type I diabetes mellitus
- Type 2 diabetes mellitus, defined as:
- Fasting plasma glucose levels greater than or equal to 26 mg/dL 2-hour postprandial Oral Glucose Tolerance Test results greater than or equal to 200 mg/dL
- Any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise.
- Chronic obstructive lung disease, peripheral vascular disease or angina that limits ability to follow exercise protocol.
- Advanced neuropathy or retinopathy.
- Smoker or have used nicotine/tobacco products within the last 12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
The Insulin Sensitivity using Aerobic Interval Conditioning (ISAIC) trial will compare traditional aerobic training (AER) to interval training (INT) in sedentary, overweight/obese men at risk for pre-diabetes. The investigators will randomly assign 42 individuals to 3 months of monitored exercise using a randomly assisgned design where participants will exercise under either AER or INT training conditions. The AER training condition will be consistent with "standard-of-care" recommendations. Exercise training will entail one 3-month blocks of either AER or INT. Training will consist of 1) a 1-month ramp up period, 2) 1-month of traditional aerobic training and 3) 1-month of either continued AER or INT.
Read the detailed description
It is currently estimated that type II diabetes (T2D) affects 5-8% of adults. Also recognized is a transitional group of individuals whose control of blood glucose is abnormal, but not yet considered diabetic. These individuals are classified as having pre-diabetes, which is defined as having impaired fasting glucose (IFG;fasting glucose 100-125 mg/dl), impaired glucose tolerance (IGT; post 2-h glucose load; 140-199 mg/dl) or both. This population represents a significant segment of the population as it is estimated that approximately 23% of Americans have pre-diabetes (IGT or IFG). Two unifying features associated with these metabolic impairments is a strong link to obesity and physical inactivity. Regular exercise positively influences IFG/IGT and obesity, and represents an important therapy for preventing the progression to T2D by enhancing several mechanisms of action including improved: glucose metabolism, muscle respiratory capacity, mitochondrial respiratory chain activity and ß-oxidation. Importantly, the dose of physical activity required to promote metabolic benefits appears to be obtainable for most individuals with as little as ~1000 kcal/w of aerobic activity.
While most exercise policy statement guidelines recommend that exercise be performed within an intensity ranging of 40-85% V02max, newer guidelines, such as the recently updated Physical Activity and Public Health Recommendations recognize that few studies have examined the effects of intensity, duration, or frequency of physical activity independent of their contribution to the total amount of physical activity. Accordingly, this writing group specifically recommended that, "based on recent data, there is some indication that vigorous-intensity activities may have greater benefit for reducing cardiovascular disease and premature mortality than moderate-intensity physical activity .... that much more work is needed is this area."
- Conditions
- Pre-diabetes
- Being tested
- Behavioral: exercise
- Keywords
- diabetes, exercise, insulin resistance, interval training, physical activity
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: exerciseOther
Specific Aim: We will identify, recruit, assess, and randomly assign 42 sedentary, overweight-obese individuals who are at risk for pre-diabetes to an AER or INT training group in order to test the hypothesis:
- Individuals randomized to INT will have greater improvements in insulin sensitivity than individuals assigned to traditional AER.
Secondary Aim: We will measure maximal cardiorespiratory fitness (VO2max/peak) in order to test the hypothesis:
- Individuals randomized to the INT group will have a greater improvement in VO2max/peak than individuals in traditional AER group.
| Study group | Role | What they receive |
|---|---|---|
| Interval Training | Experimental | The target intensity for the INT group is 2 min at about 95% of baseline VO2max followed by 2 min of recovery at 40-50% of VO2max. Regardless of the training method each participant will be "locked" into a weekly energy expenditure of 12 kilocalories per kilogram of body weight per week (KKW). Receives: Other: Behavioral: exercise |
| Aerobic Conditioning | Placebo comparator | During the first AER training condition, we will train all participants at an energy expenditure of 12 kcal/kg/wk (KKW). The target exercise intensity for the AER group will be 50%-70% of baseline V02max. Receives: Other: Behavioral: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Individulas randomized to INT will have greater improvements in insulin sensitivity than individuals assigned to traditional AER.
Measured: 3 months
Secondary outcomes (1)
Cardiorespiratory Fitness
Individuals randomized to the INT group will have a greater improvement in VO2max/peak than individuals in traditional AER group.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startJul 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Pre-diabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Conrad P. Earnest, PhD, Principal investigator, Pennington Biomedical Research CenterTimothy S. Church, MD, MPH, PhD, Study director, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286922
- Sponsor's protocol ID
- PBRC 29018
- Other IDs
- R56DK081807
- Acronym
- ISAIC
- Status last verified
- Sep 2022
- First submitted
- 28 Jan 2011
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, Wiedmeyer HM, Byrd-Holt DD. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. The Third National Health and Nutrition Examination Survey, 1988-1994. Diabetes Care. 1998 Apr;21(4):518-24. doi: 10.2337/diacare.21.4.518.
PubMed 9571335Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care. 2003 Jan;26 Suppl 1:S5-20. doi: 10.2337/diacare.26.2007.s5. No abstract available.
PubMed 12502614American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2007 Jan;30 Suppl 1:S42-7. doi: 10.2337/dc07-S042. No abstract available.
PubMed 17192378Benjamin SM, Valdez R, Geiss LS, Rolka DB, Narayan KM. Estimated number of adults with prediabetes in the US in 2000: opportunities for prevention. Diabetes Care. 2003 Mar;26(3):645-9. doi: 10.2337/diacare.26.3.645.
PubMed 12610015Zierath JR, Tsao TS, Stenbit AE, Ryder JW, Galuska D, Charron MJ. Restoration of hypoxia-stimulated glucose uptake in GLUT4-deficient muscles by muscle-specific GLUT4 transgenic complementation. J Biol Chem. 1998 Aug 14;273(33):20910-5. doi: 10.1074/jbc.273.33.20910.
PubMed 9694838Lund S, Holman GD, Schmitz O, Pedersen O. Contraction stimulates translocation of glucose transporter GLUT4 in skeletal muscle through a mechanism distinct from that of insulin. Proc Natl Acad Sci U S A. 1995 Jun 20;92(13):5817-21. doi: 10.1073/pnas.92.13.5817.
PubMed 7597034Hayashi T, Wojtaszewski JF, Goodyear LJ. Exercise regulation of glucose transport in skeletal muscle. Am J Physiol. 1997 Dec;273(6):E1039-51. doi: 10.1152/ajpendo.1997.273.6.E1039.
PubMed 9435517Turcotte LP, Richter EA, Kiens B. Increased plasma FFA uptake and oxidation during prolonged exercise in trained vs. untrained humans. Am J Physiol. 1992 Jun;262(6 Pt 1):E791-9. doi: 10.1152/ajpendo.1992.262.6.E791.
PubMed 1319676Kiens B, Essen-Gustavsson B, Christensen NJ, Saltin B. Skeletal muscle substrate utilization during submaximal exercise in man: effect of endurance training. J Physiol. 1993 Sep;469:459-78. doi: 10.1113/jphysiol.1993.sp019823.
PubMed 8271208Gregg EW, Gerzoff RB, Caspersen CJ, Williamson DF, Narayan KM. Relationship of walking to mortality among US adults with diabetes. Arch Intern Med. 2003 Jun 23;163(12):1440-7. doi: 10.1001/archinte.163.12.1440.
PubMed 12824093Fletcher GF, Blair SN, Blumenthal J, Caspersen C, Chaitman B, Epstein S, Falls H, Froelicher ES, Froelicher VF, Pina IL. Statement on exercise. Benefits and recommendations for physical activity programs for all Americans. A statement for health professionals by the Committee on Exercise and Cardiac Rehabilitation of the Council on Clinical Cardiology, American Heart association. Circulation. 1992 Jul;86(1):340-4. doi: 10.1161/01.cir.86.1.340. No abstract available.
PubMed 1617788Physical activity and cardiovascular health. NIH Consensus Development Panel on Physical Activity and Cardiovascular Health. JAMA. 1996 Jul 17;276(3):241-6.
PubMed 8667571American College of Sports Medicine Position Stand. The recommended quantity and quality of exercise for developing and maintaining cardiorespiratory and muscular fitness, and flexibility in healthy adults. Med Sci Sports Exerc. 1998 Jun;30(6):975-91. doi: 10.1097/00005768-199806000-00032.
PubMed 9624661Albright A, Franz M, Hornsby G, Kriska A, Marrero D, Ullrich I, Verity LS. American College of Sports Medicine position stand. Exercise and type 2 diabetes. Med Sci Sports Exerc. 2000 Jul;32(7):1345-60. doi: 10.1097/00005768-200007000-00024.
PubMed 10912903Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1423-34. doi: 10.1249/mss.0b013e3180616b27.
PubMed 17762377
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Insulin Sensitivity Using Aerobic Interval Conditioning
- ClinicalTrials.gov ID
- NCT01286922
- Acronym / sponsor ID
- ISAIC / PBRC 29018
- Conditions
- Pre-diabetes
- Keywords
- diabetes, exercise, insulin resistance, interval training, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 31 Jan 2011 (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 Insulin Sensitivity using Aerobic Interval Conditioning (ISAIC) trial will compare traditional aerobic training (AER) to interval training (INT) in sedentary, overweight/obese men at risk for pre-diabetes. The investigators will randomly assign 42 individuals to 3 months of monitored exercise using a randomly assisgned design where participants will exercise under either AER or INT training conditions. The AER training condition will be consistent with "standard-of-care" recommendations. Exercise training will entail one 3-month blocks of either AER or INT. Training will consist of 1) a 1-month ramp up period, 2) 1-month of traditional aerobic training and 3) 1-month of either continued AER or INT.
Detailed description
It is currently estimated that type II diabetes (T2D) affects 5-8% of adults. Also recognized is a transitional group of individuals whose control of blood glucose is abnormal, but not yet considered diabetic. These individuals are classified as having pre-diabetes, which is defined as having impaired fasting glucose (IFG;fasting glucose 100-125 mg/dl), impaired glucose tolerance (IGT; post 2-h glucose load; 140-199 mg/dl) or both. This population represents a significant segment of the population as it is estimated that approximately 23% of Americans have pre-diabetes (IGT or IFG). Two unifying features associated with these metabolic impairments is a strong link to obesity and physical inactivity. Regular exercise positively influences IFG/IGT and obesity, and represents an important therapy for preventing the progression to T2D by enhancing several mechanisms of action including improved: glucose metabolism, muscle respiratory capacity, mitochondrial respiratory chain activity and ß-oxidation. Importantly, the dose of physical activity required to promote metabolic benefits appears to be obtainable for most individuals with as little as ~1000 kcal/w of aerobic activity.
While most exercise policy statement guidelines recommend that exercise be performed within an intensity ranging of 40-85% V02max, newer guidelines, such as the recently updated Physical Activity and Public Health Recommendations recognize that few studies have examined the effects of intensity, duration, or frequency of physical activity independent of their contribution to the total amount of physical activity. Accordingly, this writing group specifically recommended that, "based on recent data, there is some indication that vigorous-intensity activities may have greater benefit for reducing cardiovascular disease and premature mortality than moderate-intensity physical activity .... that much more work is needed is this area."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interval Training | Experimental | Other: Behavioral: exerciseThe target intensity for the INT group is 2 min at about 95% of baseline VO2max followed by 2 min of recovery at 40-50% of VO2max. Regardless of the training method each participant will be "locked" into a weekly energy expenditure of 12 kilocalories per kilogram of body weight per week (KKW). |
| Aerobic Conditioning | Placebo comparator | Other: Behavioral: exerciseDuring the first AER training condition, we will train all participants at an energy expenditure of 12 kcal/kg/wk (KKW). The target exercise intensity for the AER group will be 50%-70% of baseline V02max. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 30 to 60 years, inclusive
- BMI greater than or equal to 25 - less than or equal to 35 kg/m2
- Waist circumference >38"; Waist-to-Hip Ratio >0.95 Sedentary Lifestvle
- Not physically active greater than or equal to 3 days/week-l for 20 min each time for the previous 6 months,
- Not participating in regular resistance exercise
Key exclusion criteria (28 listed)
- Resting blood pressure greater than or equal to 160/100 mm Hg
- Triglycerides greater than or equal to 500 mg/dL
- Factors that may limit adherence to intervention or affect conduct of the trial such as lack of time, amount of travel, and/or work or family stressors
- Unable or willing to communicate with staff, to provide written informed consent, or accept the randomized assignment
- Failure to complete behavioral run-in and baseline testing
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 |
|---|---|---|
| Behavioral: exerciseSpecific Aim: We will identify, recruit, assess, and randomly assign 42 sedentary, overweight-obese individuals who are at risk for pre-diabetes to an AER or INT training group in order to test the hypothesis: • Individuals randomized to INT will have greater improvements in insulin sensitivity than individuals assigned to traditional AER. Secondary Aim: We will measure maximal cardiorespiratory fitness (VO2max/peak) in order to test the hypothesis: • Individuals randomized to the INT group will have a greater improvement in VO2max/peak than individuals in traditional AER group. | Other | Aerobic Conditioning, Interval Training |
Primary outcome
Insulin Sensitivity
Time frame: 3 months
Individulas randomized to INT will have greater improvements in insulin sensitivity than individuals assigned to traditional AER.
1 secondary outcome
Cardiorespiratory Fitness
Time frame: 3 months
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 15 Sep 2022.
- Background: PubMed 9571335Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, Wiedmeyer HM, Byrd-Holt DD. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. The Third National Health and Nutrition Examination Survey, 1988-1994. Diabetes Care. 1998 Apr;21(4):518-24. doi: 10.2337/diacare.21.4.518.
- Background: PubMed 12502614Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care. 2003 Jan;26 Suppl 1:S5-20. doi: 10.2337/diacare.26.2007.s5. No abstract available.
- Background: PubMed 17192378American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2007 Jan;30 Suppl 1:S42-7. doi: 10.2337/dc07-S042. No abstract available.
- Background: PubMed 12610015Benjamin SM, Valdez R, Geiss LS, Rolka DB, Narayan KM. Estimated number of adults with prediabetes in the US in 2000: opportunities for prevention. Diabetes Care. 2003 Mar;26(3):645-9. doi: 10.2337/diacare.26.3.645.
- Background: PubMed 9694838Zierath JR, Tsao TS, Stenbit AE, Ryder JW, Galuska D, Charron MJ. Restoration of hypoxia-stimulated glucose uptake in GLUT4-deficient muscles by muscle-specific GLUT4 transgenic complementation. J Biol Chem. 1998 Aug 14;273(33):20910-5. doi: 10.1074/jbc.273.33.20910.
- Background: PubMed 7597034Lund S, Holman GD, Schmitz O, Pedersen O. Contraction stimulates translocation of glucose transporter GLUT4 in skeletal muscle through a mechanism distinct from that of insulin. Proc Natl Acad Sci U S A. 1995 Jun 20;92(13):5817-21. doi: 10.1073/pnas.92.13.5817.
- Background: PubMed 9435517Hayashi T, Wojtaszewski JF, Goodyear LJ. Exercise regulation of glucose transport in skeletal muscle. Am J Physiol. 1997 Dec;273(6):E1039-51. doi: 10.1152/ajpendo.1997.273.6.E1039.
- Background: PubMed 1319676Turcotte LP, Richter EA, Kiens B. Increased plasma FFA uptake and oxidation during prolonged exercise in trained vs. untrained humans. Am J Physiol. 1992 Jun;262(6 Pt 1):E791-9. doi: 10.1152/ajpendo.1992.262.6.E791.
- Background: PubMed 8271208Kiens B, Essen-Gustavsson B, Christensen NJ, Saltin B. Skeletal muscle substrate utilization during submaximal exercise in man: effect of endurance training. J Physiol. 1993 Sep;469:459-78. doi: 10.1113/jphysiol.1993.sp019823.
- Background: PubMed 12824093Gregg EW, Gerzoff RB, Caspersen CJ, Williamson DF, Narayan KM. Relationship of walking to mortality among US adults with diabetes. Arch Intern Med. 2003 Jun 23;163(12):1440-7. doi: 10.1001/archinte.163.12.1440.
- Background: PubMed 1617788Fletcher GF, Blair SN, Blumenthal J, Caspersen C, Chaitman B, Epstein S, Falls H, Froelicher ES, Froelicher VF, Pina IL. Statement on exercise. Benefits and recommendations for physical activity programs for all Americans. A statement for health professionals by the Committee on Exercise and Cardiac Rehabilitation of the Council on Clinical Cardiology, American Heart association. Circulation. 1992 Jul;86(1):340-4. doi: 10.1161/01.cir.86.1.340. No abstract available.
- Background: PubMed 8667571Physical activity and cardiovascular health. NIH Consensus Development Panel on Physical Activity and Cardiovascular Health. JAMA. 1996 Jul 17;276(3):241-6.
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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.
Conrad P. Earnest, PhD principal investigator
Pennington Biomedical Research Center
Timothy S. Church, MD, MPH, PhD study director
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: exercise in people with Pre-diabetes, run by Pennington Biomedical Research Center 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 5 inclusion and 28 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 15 Sep 2022. 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. Some participants in this study may receive a placebo. 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?
Insulin Sensitivity (time frame: 3 months). 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 NCT01286922, which also lists 16 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 15 Sep 2022.