Impaired Glucose TolerancePhase 2/3NCT00594399
Enhancing Fitness in Older Pre-diabetic Veterans
A Phase 2/3 study testing Physical Activity Counseling in people with Impaired Glucose Tolerance and Obesity, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This study targets older adults (ages 60 and over) who are overweight (body mass index 25-40) with impaired fasting glucose (100 - 125). We propose a three-year, randomized controlled clinical trial (n=300) to determine the effect of a one-year physical activity counseling intervention on glucose metabolism and… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Impaired Glucose Tolerance, Obesity, Diabetes
- What is being tested?
- Physical Activity Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jun 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- VA patients followed by the Durham VA Primary Care, Women's Health, and Geriatric clinics
- Must have had more than one visit to the VA in preceding 12 months
- Age 60 and over
- Impaired glucose intolerance documented by recent fasting blood glucose between 100 and 125 mg/dL
- Body mass index between 25-40 kg/m2
- Able to walk 10 meters without human assistance (assistive device acceptable)
- All participants must be assigned a primary care provider and have had more than one visit to the VA in the preceding 12 months
Who cannot join
- Free of frank diabetes
- Fasting blood sugar above 125 mg/dL
- HbA1c > 7%
- Unstable angina
- Recent history of ventricular tachycardia
- Unstable chronic obstructive pulmonary disease (two hospitalizations within the previous 12 months and/or on oxygen)
Show all 16Show fewer
- Uncontrolled hypertension (diastolic blood pressure >110 mm/Hg or systolic > 200mm/Hg)
- Stroke with moderate to severe aphasia
- Diagnosis of chronic pain which may interfere with their ability to be physically active
- Diagnosis of unstable mental or behavioral disorder
- Diagnosis of memory loss or dementia
- Visual or hearing loss severe enough to interfere with ability to receive telephone counseling and review written materials
- Active substance abuse
- A terminal diagnosis
- Followed by VA for medications only
- Regularly, vigorously physically active for six months or longer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
About this study
Official title: Enhancing Fitness in Older Overweight Vets With Impaired Fasting Glucose
This study targets older adults (ages 60 and over) who are overweight (body mass index 25-40) with impaired fasting glucose (100 - 125). We propose a three-year, randomized controlled clinical trial (n=300) to determine the effect of a one-year physical activity counseling intervention on glucose metabolism and secondary outcomes compared to usual care.
Read the detailed description
IMPACT. Our proposed project will contribute to improved quality and efficiency of VA health care by: (1) providing an effective program of Enhanced Fitness counseling that will result in a significant increase in physical activity of sufficient magnitude to achieve noted improvements in glycemic control, and (2) developing and disseminating materials that can be used throughout the VHA for physical activity promotion for older, overweight adults.
BACKGROUND. The nation is experiencing a marked increase in obesity, and diabetes. Users of the VA medical facilities report higher than national average rates of obesity and diabetes. Current projections indicate that 70% of veterans using the VA medical care are overweight, 20% have diabetes, and 30- 40 % have metabolic syndrome. Approximately 30 % of VA health care costs are attributable to care for diabetes alone. Incidence and prevalence of these conditions increase with age and are associated with high medical costs. This is especially true of the older adult who typically has added comorbidities and functional limitations. The VHA has aggressively addressed the existing epidemic by implementing various programs and performance measures aimed at attaining optimal medical management of dyslipidemia, diabetes, and obesity. The component of all of these initiatives that has received the least amount of attention is physical activity despite overwhelming evidence that physical activity can favorably alter all of the medical conditions described above. The VA system-wide has been ill equipped to provide feasible, cost effective physical activity programs despite the imperative to seek ways to reduce incident diabetes and reduce potential health care costs.
OBJECTIVES. We propose an innovative home-based enhanced fitness counseling intervention that involves a unique partnership between veteran, primary care provider, and exercise counselor directed at the older adult. The proposed project, Enhanced Fitness, seeks to improve glycemic control in older, overweight adults with impaired fasting glucose receiving primary care at the VA. A novel design, adaptive randomization, will allow us to assess the impact of our intervention at an early stage and then reassign individuals to a more intense or reduced intervention based upon patient compliance. Due to the national implementation of MOVE! in primary care for the treatment of obesity we will consider MOVE! as part of usual care for this population. Primary Hypothesis. Compared to usual care (plus MOVE!), individuals receiving Enhanced Fitness counseling will have significantly improved glucose metabolism (fasting insulin). Secondary Research Hypotheses and Objectives. (1) Compared to usual care (plus MOVE!), individuals receiving Enhanced Fitness counseling will have significantly improved secondary outcomes related glycemic control (fasting blood glucose, HOMA-IR, HbA1c, metabolic syndrome score), physical function (self report and physical performance), disability, and health related quality of life; and (2) To determine differences in cost and health care utilization between groups.
Note: 7/5/2010: An amendment was submitted and approved to drop the adaptive randomization component of the study. This was necessary due to low levels of noncompliance observed during the first follow-up assessment. The primary and secondary objectives of the study were not affected by this amendment.
Another amendment was submitted and approved to: 1) evaluate the association between APOE, diabetic risk and physical function; and 2) to examine associations between inflammatory markers, diabetic risk, and physical function.
METHODS: For the proposed study we will target older adults (ages 60 and over) who are overweight (body mass index >24-40) with impaired fasting glucose (100 - 125). We propose a three-year, randomized controlled clinical trial (n=300) to determine the effect of our 1-year Enhanced Fitness counseling intervention on glucose metabolism. A novel design, adaptive randomization, will allow us to mimic primary care by altering treatment based upon patient compliance. We will use a "train the trainers" approach for dissemination of results at the local, VISN, and national level.
- Conditions
- Impaired Glucose Tolerance, Obesity, Diabetes
- Being tested
- Physical Activity Counseling
- Keywords
- Aging, Exercise, Impaired Glucose Tolerance, Obesity, Functional Status, Disability, Health Services Research, Randomized Controlled Trial, Diabetes, Adaptive Randomization Design
- Medical subject headings
- Glucose Intolerance, Obesity, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity CounselingBehavioural
Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Physical Activity counseling | Experimental | Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback. Receives: Behavioral: Physical Activity Counseling |
| Arm 2 | No intervention | Usual care from primary, womens or geriatric clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Insulin
Fasting Insulin analyzed at VA central laboratory by technicians not affiliated with study. Participants were instructed to refrain from eating or drinking anything except water and medications past midnight. A reminder call was placed the night before the scheduled appointment and fasting was verified by study personnel before appointed blood draws.
Measured: Baseline
3 Month Fasting Insulin
Measured: 3 month
12 Month Fasting Insulin
Measured: 12 months
Fasting Glucose
Measured: Baseline
3 Month Fasting Glucose
Measured: 3 months
12 Month Fasting Glucose
Measured: 12 Months
Secondary outcomes (3)
Physical Activity, Endurance
Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.
Measured: Baseline
Physical Activity, Endurance
Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.
Measured: 3 months
Physical Activity, Endurance
Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Impaired Glucose ToleranceStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Miriam C. Morey, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594399
- Sponsor's protocol ID
- IIR 06-252
- Status last verified
- Aug 2014
- First submitted
- 3 Jan 2008
- Last updated
- 27 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Turer CB, Bernstein IH, Edelman DE, Yancy WS Jr. Low HDL predicts differential blood pressure effects from two weight-loss approaches: a secondary analysis of blood pressure from a randomized, clinical weight-loss trial. Diabetes Obes Metab. 2012 Apr;14(4):375-8. doi: 10.1111/j.1463-1326.2011.01531.x. Epub 2011 Dec 27.
PubMed 22059803Morey MC, Pieper CF, Edelman DE, Yancy WS Jr, Green JB, Lum H, Peterson MJ, Sloane R, Cowper PA, Bosworth HB, Huffman KM, Cavanaugh JT, Hall KS, Pearson MP, Taylor GA. Enhanced fitness: a randomized controlled trial of the effects of home-based physical activity counseling on glycemic control in older adults with prediabetes mellitus. J Am Geriatr Soc. 2012 Sep;60(9):1655-62. doi: 10.1111/j.1532-5415.2012.04119.x.
PubMed 22985140Hall KS, Pieper CF, Edelman DE, Yancy WS Jr, Green JB, Lum H, Peterson MJ, Sloane R, Cowper PA, Bosworth HB, Huffman KM, Cavanaugh JT, Chapman JG, Pearson MP, Howard TA, Ekelund CC, McCraw BL, Burrell JB, Taylor GA, Morey MC. Lessons learned when innovations go awry: a baseline description of a behavioral trial-the Enhancing Fitness in Older Overweight Veterans with Impaired Fasting Glucose study. Transl Behav Med. 2011 Nov;1(4):573-587. doi: 10.1007/s13142-011-0075-6.
PubMed 22866170Povsic TJ, Sloane R, Green JB, Zhou J, Pieper CF, Pearson MP, Peterson ED, Cohen HJ, Morey MC. Depletion of circulating progenitor cells precedes overt diabetes: a substudy from the VA enhanced fitness trial. J Diabetes Complications. 2013 Nov-Dec;27(6):633-6. doi: 10.1016/j.jdiacomp.2013.08.004. Epub 2013 Sep 19.
PubMed 24055327Hall KS, Beckham JC, Bosworth HB, Sloane R, Pieper CF, Morey MC. PTSD is negatively associated with physical performance and physical function in older overweight military Veterans. J Rehabil Res Dev. 2014;51(2):285-95. doi: 10.1682/JRRD.2013.04.0091.
PubMed 24933726Povsic TJ, Sloane R, Zhou J, Pieper CF, Pearson MP, Peterson ED, Green JB, Cohen HJ, Morey MC. Lower levels of circulating progenitor cells are associated with low physical function and performance in elderly men with impaired glucose tolerance: a pilot substudy from the VA Enhanced Fitness trial. J Gerontol A Biol Sci Med Sci. 2013 Dec;68(12):1559-66. doi: 10.1093/gerona/glt067. Epub 2013 May 16.
PubMed 23682163Povsic TJ, Sloane R, Pieper CF, Pearson MP, Peterson ED, Cohen HJ, Morey MC. Endothelial Progenitor Cell Levels Predict Future Physical Function: An Exploratory Analysis From the VA Enhanced Fitness Study. J Gerontol A Biol Sci Med Sci. 2016 Mar;71(3):362-9. doi: 10.1093/gerona/glv180. Epub 2015 Oct 28.
PubMed 26511012
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Fitness in Older Overweight Vets With Impaired Fasting Glucose
- ClinicalTrials.gov ID
- NCT00594399
- Acronym / sponsor ID
- IIR 06-252
- Conditions
- Impaired Glucose Tolerance, Obesity, Diabetes
- Keywords
- Aging, Exercise, Impaired Glucose Tolerance, Obesity, Functional Status, Disability, Health Services Research, Randomized Controlled Trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Posted 9 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study targets older adults (ages 60 and over) who are overweight (body mass index 25-40) with impaired fasting glucose (100 - 125). We propose a three-year, randomized controlled clinical trial (n=300) to determine the effect of a one-year physical activity counseling intervention on glucose metabolism and secondary outcomes compared to usual care.
Detailed description
IMPACT. Our proposed project will contribute to improved quality and efficiency of VA health care by: (1) providing an effective program of Enhanced Fitness counseling that will result in a significant increase in physical activity of sufficient magnitude to achieve noted improvements in glycemic control, and (2) developing and disseminating materials that can be used throughout the VHA for physical activity promotion for older, overweight adults.
BACKGROUND. The nation is experiencing a marked increase in obesity, and diabetes. Users of the VA medical facilities report higher than national average rates of obesity and diabetes. Current projections indicate that 70% of veterans using the VA medical care are overweight, 20% have diabetes, and 30- 40 % have metabolic syndrome. Approximately 30 % of VA health care costs are attributable to care for diabetes alone. Incidence and prevalence of these conditions increase with age and are associated with high medical costs. This is especially true of the older adult who typically has added comorbidities and functional limitations. The VHA has aggressively addressed the existing epidemic by implementing various programs and performance measures aimed at attaining optimal medical management of dyslipidemia, diabetes, and obesity. The component of all of these initiatives that has received the least amount of attention is physical activity despite overwhelming evidence that physical activity can favorably alter all of the medical conditions described above. The VA system-wide has been ill equipped to provide feasible, cost effective physical activity programs despite the imperative to seek ways to reduce incident diabetes and reduce potential health care costs.
OBJECTIVES. We propose an innovative home-based enhanced fitness counseling intervention that involves a unique partnership between veteran, primary care provider, and exercise counselor directed at the older adult. The proposed project, Enhanced Fitness, seeks to improve glycemic control in older, overweight adults with impaired fasting glucose receiving primary care at the VA. A novel design, adaptive randomization, will allow us to assess the impact of our intervention at an early stage and then reassign individuals to a more intense or reduced intervention based upon patient compliance. Due to the national implementation of MOVE! in primary care for the treatment of obesity we will consider MOVE! as part of usual care for this population. Primary Hypothesis. Compared to usual care (plus MOVE!), individuals receiving Enhanced Fitness counseling will have significantly improved glucose metabolism (fasting insulin). Secondary Research Hypotheses and Objectives. (1) Compared to usual care (plus MOVE!), individuals receiving Enhanced Fitness counseling will have significantly improved secondary outcomes related glycemic control (fasting blood glucose, HOMA-IR, HbA1c, metabolic syndrome score), physical function (self report and physical performance), disability, and health related quality of life; and (2) To determine differences in cost and health care utilization between groups.
Note: 7/5/2010: An amendment was submitted and approved to drop the adaptive randomization component of the study. This was necessary due to low levels of noncompliance observed during the first follow-up assessment. The primary and secondary objectives of the study were not affected by this amendment.
Another amendment was submitted and approved to: 1) evaluate the association between APOE, diabetic risk and physical function; and 2) to examine associations between inflammatory markers, diabetic risk, and physical function.
METHODS: For the proposed study we will target older adults (ages 60 and over) who are overweight (body mass index >24-40) with impaired fasting glucose (100 - 125). We propose a three-year, randomized controlled clinical trial (n=300) to determine the effect of our 1-year Enhanced Fitness counseling intervention on glucose metabolism. A novel design, adaptive randomization, will allow us to mimic primary care by altering treatment based upon patient compliance. We will use a "train the trainers" approach for dissemination of results at the local, VISN, and national level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Physical Activity counseling | Experimental | Behavioral: Physical Activity CounselingPhysical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback. |
| Arm 2 | No intervention | –Usual care from primary, womens or geriatric clinics |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- VA patients followed by the Durham VA Primary Care, Women's Health, and Geriatric clinics
- Must have had more than one visit to the VA in preceding 12 months
- Age 60 and over
- Impaired glucose intolerance documented by recent fasting blood glucose between 100 and 125 mg/dL
- Body mass index between 25-40 kg/m2
Key exclusion criteria (16 listed)
- Free of frank diabetes
- Fasting blood sugar above 125 mg/dL
- HbA1c > 7%
- Unstable angina
- Recent history of ventricular tachycardia
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 |
|---|---|---|
| Physical Activity CounselingPhysical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback. | Behavioural | Arm 1 Physical Activity counseling |
Primary outcome
Fasting Insulin
Time frame: Baseline
Fasting Insulin analyzed at VA central laboratory by technicians not affiliated with study. Participants were instructed to refrain from eating or drinking anything except water and medications past midnight. A reminder call was placed the night before the scheduled appointment and fasting was verified by study personnel before appointed blood draws.
3 Month Fasting Insulin
Time frame: 3 month
12 Month Fasting Insulin
Time frame: 12 months
Fasting Glucose
Time frame: Baseline
3 Month Fasting Glucose
Time frame: 3 months
12 Month Fasting Glucose
Time frame: 12 Months
3 secondary outcomes
Physical Activity, Endurance
Time frame: Baseline
Physical Activity, Endurance
Time frame: 3 months
Physical Activity, Endurance
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22059803Turer CB, Bernstein IH, Edelman DE, Yancy WS Jr. Low HDL predicts differential blood pressure effects from two weight-loss approaches: a secondary analysis of blood pressure from a randomized, clinical weight-loss trial. Diabetes Obes Metab. 2012 Apr;14(4):375-8. doi: 10.1111/j.1463-1326.2011.01531.x. Epub 2011 Dec 27.
- Results publication: PubMed 22985140Morey MC, Pieper CF, Edelman DE, Yancy WS Jr, Green JB, Lum H, Peterson MJ, Sloane R, Cowper PA, Bosworth HB, Huffman KM, Cavanaugh JT, Hall KS, Pearson MP, Taylor GA. Enhanced fitness: a randomized controlled trial of the effects of home-based physical activity counseling on glycemic control in older adults with prediabetes mellitus. J Am Geriatr Soc. 2012 Sep;60(9):1655-62. doi: 10.1111/j.1532-5415.2012.04119.x.
- Results publication: PubMed 22866170Hall KS, Pieper CF, Edelman DE, Yancy WS Jr, Green JB, Lum H, Peterson MJ, Sloane R, Cowper PA, Bosworth HB, Huffman KM, Cavanaugh JT, Chapman JG, Pearson MP, Howard TA, Ekelund CC, McCraw BL, Burrell JB, Taylor GA, Morey MC. Lessons learned when innovations go awry: a baseline description of a behavioral trial-the Enhancing Fitness in Older Overweight Veterans with Impaired Fasting Glucose study. Transl Behav Med. 2011 Nov;1(4):573-587. doi: 10.1007/s13142-011-0075-6.
- Results publication: PubMed 24055327Povsic TJ, Sloane R, Green JB, Zhou J, Pieper CF, Pearson MP, Peterson ED, Cohen HJ, Morey MC. Depletion of circulating progenitor cells precedes overt diabetes: a substudy from the VA enhanced fitness trial. J Diabetes Complications. 2013 Nov-Dec;27(6):633-6. doi: 10.1016/j.jdiacomp.2013.08.004. Epub 2013 Sep 19.
- Results publication: PubMed 24933726Hall KS, Beckham JC, Bosworth HB, Sloane R, Pieper CF, Morey MC. PTSD is negatively associated with physical performance and physical function in older overweight military Veterans. J Rehabil Res Dev. 2014;51(2):285-95. doi: 10.1682/JRRD.2013.04.0091.
- Results publication: PubMed 23682163Povsic TJ, Sloane R, Zhou J, Pieper CF, Pearson MP, Peterson ED, Green JB, Cohen HJ, Morey MC. Lower levels of circulating progenitor cells are associated with low physical function and performance in elderly men with impaired glucose tolerance: a pilot substudy from the VA Enhanced Fitness trial. J Gerontol A Biol Sci Med Sci. 2013 Dec;68(12):1559-66. doi: 10.1093/gerona/glt067. Epub 2013 May 16.
- Derived from this study: PubMed 26511012Povsic TJ, Sloane R, Pieper CF, Pearson MP, Peterson ED, Cohen HJ, Morey MC. Endothelial Progenitor Cell Levels Predict Future Physical Function: An Exploratory Analysis From the VA Enhanced Fitness Study. J Gerontol A Biol Sci Med Sci. 2016 Mar;71(3):362-9. doi: 10.1093/gerona/glv180. Epub 2015 Oct 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.
Miriam C. Morey, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Physical Activity Counseling in people with Impaired Glucose Tolerance and Obesity, run by US Department of Veterans Affairs 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 7 inclusion and 16 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 27 Apr 2015. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fasting Insulin (time frame: Baseline). The study lists 6 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 NCT00594399, which also lists 7 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 27 Apr 2015.