Type 2 DiabetesHART-DNCT00458133
Health Benefits of Aerobic and Resistance Training in Individuals With Type 2 Diabetes
A study testing exercise in people with Type 2 Diabetes, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The goal of the proposed study, Health Benefits of Aerobic and Resistance Training in individuals with type 2 diabetes (HART-D), is to compare the effect of resistance training alone (RT), resistance in combination with aerobic training (AT+RT), and aerobic training alone (AT) to standard care (SC) on hemoglobin A1C… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jun 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-75 years
- type 2 diabetes determined by self-report with verification
- 6.5% < HbA1C < 11%
- sedentary lifestyle - not being physically active greater than or equal to 3 days per week for 20 minutes each time for the previous 6 months, and not performing regular resistance exercise
Who cannot join
- inadequate control of co-morbid conditions
- resting blood pressure greater than or equal to 160/100 mm Hg
- Triglycerides greater than or equal to 500 mg/dL
- BMI is greater than or equal to 48
- current use of an insulin pump or insulin injections other than Lantus
- metal object in the body that may interfere with MRI/MRS scans
Show all 28Show fewer
- factors that may limit adherence to intervention or affect conduct of the trial
- unable or unwilling 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
- not physically capable of performing the exercise required for the study protocols
- consuming > 14 alcoholic beverages per week
- plans to be away > 4 weeks in the next 9 months
- lack of support from primary health care provider or family members
- significant weight loss in the past year (>20 lbs) or current use of weight loss medications
- current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
- another member of household is a participant or staff member of HART-D
- bariatric surgery
- 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
- pregnant or plan on becoming pregnant in the next 9 months
- cancers requiring treatment in the past 5 years, unless prognosis is excellent
- self-reported HIV or tuberculosis
- history or evidence of serious arrythmias, cardiomyopathy, congestive heart failure, aortic aneurysm, or heart transplantation
- renal disease: urine dipstick 4+ protein, serum creatinine is greater than or equal to 1.4 mg/dL (women) or is greater than or equal to 1.5 mg/dL (men) or currently receiving dialysis
- any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise
- advanced neuropathy or retinopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70817
About this study
The goal of the proposed study, Health Benefits of Aerobic and Resistance Training in individuals with type 2 diabetes (HART-D), is to compare the effect of resistance training alone (RT), resistance in combination with aerobic training (AT+RT), and aerobic training alone (AT) to standard care (SC) on hemoglobin A1C (HbA1C), in initially sedentary women and men with type 2 diabetes (T2D).
Read the detailed description
Although it is generally accepted that regular exercise provides substantial health benefits to individuals with T2D, the exact exercise prescription in terms of type (AT versus RT versus AT+RT) still remains an important research issue, particularly in regard to week-to-week glucose control as assessed by HbA1C.
There is a need for more adequately powered and well-controlled studies to examine the effects of RT, AT and AT+RT on HbA1C in individuals with T2D. With the incidence of T2D expected to increase dramatically in the coming years, it is essential to have a better understanding of the relative benefits of various exercise interventions. This information can help better formulate exercise recommendations for patients with T2D as well as potentially provide more exercise options, which is important given the small percentage of individuals with TD2 who regularly exercise. The study group was sedentary women and men with T2D, aged 30 to 75 years. We randomly assigned 262 individuals to an aerobic exercise training only group (AT; n=72), a resistance training only group (RT; n=73), a combination of aerobic plus resistance training (AT+RT; n=76), or a standard care group (SC; n=41). The AT individuals participated in 3 or 4 training sessions each week for 9 months progressing to a total energy expenditure of 12 kcal/kg/week (KKW), which is an exercise dose consistent with the current public health recommendations for physical activity for individuals with T2D. The target exercise intensity was 50%-80% of baseline VO2 max. The RT group participated in 3 sessions per week (9 exercises, 2-3 sets each), which focuses on large muscle groups. This RT regimen is based on the studies that most successfully improved HbA1C in individuals with T2D. Individuals in the AT+RT group completed 10 KKW of aerobic training and a reduced resistance-training regimen of 2 sessions per week (9 exercises, 1 set of each). The AT+RT regimen represents the exercise recommendations of the American College of Sports Medicine (ACSM) and the American Diabetes Association (ADA).
Simply stated, we compared the effect of resistance training alone, resistance in combination with aerobic training, and aerobic training alone to standard care on HbA1C, in initially sedentary women and men with T2D. The primary outcome measure was HbA1C, an integrated measure of blood glucose control over the past 8-12 weeks. Other outcomes of interest included resting blood pressure, C-reactive protein (CRP), total body fat, and lean muscle mass as measured by DEXA, cardiorespiratory fitness, muscular strength, and metabolic measures including serum cholesterol and triglycerides.
- Conditions
- Type 2 Diabetes
- Being tested
- exercise
- Keywords
- aerobic exercise, resistance exercise, type 2 diabetes, hemoglobin A1C, exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
compared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching \& relaxing groups.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | We randomly assigned 72 individuals to an aerobic exercise training only group. Receives: Behavioral: exercise |
| 2 | Experimental | We randomly assigned 73 individuals to an resistance exercise training only group. Receives: Behavioral: exercise |
| 3 | Experimental | We randomly assigned 76 individuals to a combination of aerobic plus resistance training group. Receives: Behavioral: exercise |
| 4 | Placebo comparator | We randomly assigned 41 individuals to a stretching and relaxation group. Receives: Behavioral: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C
Measured: at 9 months
Secondary outcomes (9)
Fasting glucose
Measured: at 9 months
Basal insulin
Measured: at 9 months
Resting blood pressure
Measured: at 9 months
C reactive protein
Measured: at 9 months
Visceral adiposity
Measured: at 9 months
Body Composition
Measured: at 9 months
Cardiorespiratory fitness
Measured: at 9 months
Muscular strength
Measured: at 9 months
metabolic measures, including serum cholesterol and triglycerides
Measured: at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionMar 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy S Church, MPH, MD, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458133
- Sponsor's protocol ID
- PBRC 26046
- Other IDs
- R01DK068298
- Acronym
- HART-D
- Status last verified
- Sep 2022
- First submitted
- 5 Apr 2007
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zinman B, Ruderman N, Campaigne BN, Devlin JT, Schneider SH; American Diabetes Association. Physical activity/exercise and diabetes mellitus. Diabetes Care. 2003 Jan;26 Suppl 1:S73-7. doi: 10.2337/diacare.26.2007.s73. No abstract available.
PubMed 12502622Albright 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 10912903Hamdy O, Goodyear LJ, Horton ES. Diet and exercise in type 2 diabetes mellitus. Endocrinol Metab Clin North Am. 2001 Dec;30(4):883-907. doi: 10.1016/s0889-8529(05)70220-6.
PubMed 11727404Kelley DE, Goodpaster BH. Effects of exercise on glucose homeostasis in Type 2 diabetes mellitus. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S495-501; discussion S528-9. doi: 10.1097/00005768-200106001-00020.
PubMed 11427776Nelson KM, Reiber G, Boyko EJ; NHANES III. Diet and exercise among adults with type 2 diabetes: findings from the third national health and nutrition examination survey (NHANES III). Diabetes Care. 2002 Oct;25(10):1722-8. doi: 10.2337/diacare.25.10.1722.
PubMed 12351468Khaw KT, Wareham N, Luben R, Bingham S, Oakes S, Welch A, Day N. Glycated haemoglobin, diabetes, and mortality in men in Norfolk cohort of european prospective investigation of cancer and nutrition (EPIC-Norfolk). BMJ. 2001 Jan 6;322(7277):15-8. doi: 10.1136/bmj.322.7277.15.
PubMed 11141143Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.
PubMed 9742976Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. doi: 10.1001/jama.286.10.1218.
PubMed 11559268Ishii T, Yamakita T, Sato T, Tanaka S, Fujii S. Resistance training improves insulin sensitivity in NIDDM subjects without altering maximal oxygen uptake. Diabetes Care. 1998 Aug;21(8):1353-5. doi: 10.2337/diacare.21.8.1353.
PubMed 9702447Baldi JC, Snowling N. Resistance training improves glycaemic control in obese type 2 diabetic men. Int J Sports Med. 2003 Aug;24(6):419-23. doi: 10.1055/s-2003-41173.
PubMed 12905089Castaneda C, Layne JE, Munoz-Orians L, Gordon PL, Walsmith J, Foldvari M, Roubenoff R, Tucker KL, Nelson ME. A randomized controlled trial of resistance exercise training to improve glycemic control in older adults with type 2 diabetes. Diabetes Care. 2002 Dec;25(12):2335-41. doi: 10.2337/diacare.25.12.2335.
PubMed 12453982Dunstan DW, Daly RM, Owen N, Jolley D, De Courten M, Shaw J, Zimmet P. High-intensity resistance training improves glycemic control in older patients with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1729-36. doi: 10.2337/diacare.25.10.1729.
PubMed 12351469Kumar S, Boulton AJ, Beck-Nielsen H, Berthezene F, Muggeo M, Persson B, Spinas GA, Donoghue S, Lettis S, Stewart-Long P. Troglitazone, an insulin action enhancer, improves metabolic control in NIDDM patients. Troglitazone Study Group. Diabetologia. 1996 Jun;39(6):701-9. doi: 10.1007/BF00418542.
PubMed 8781766Hanley AJ, Williams K, Stern MP, Haffner SM. Homeostasis model assessment of insulin resistance in relation to the incidence of cardiovascular disease: the San Antonio Heart Study. Diabetes Care. 2002 Jul;25(7):1177-84. doi: 10.2337/diacare.25.7.1177.
PubMed 12087016Katsuki A, Sumida Y, Gabazza EC, Murashima S, Furuta M, Araki-Sasaki R, Hori Y, Yano Y, Adachi Y. Homeostasis model assessment is a reliable indicator of insulin resistance during follow-up of patients with type 2 diabetes. Diabetes Care. 2001 Feb;24(2):362-5. doi: 10.2337/diacare.24.2.362.
PubMed 11213893
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
- Health Benefits of Aerobic and Resistance Training in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00458133
- Acronym / sponsor ID
- HART-D / PBRC 26046
- Conditions
- Type 2 Diabetes
- Keywords
- aerobic exercise, resistance exercise, type 2 diabetes, hemoglobin A1C, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 9 Apr 2007 (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 goal of the proposed study, Health Benefits of Aerobic and Resistance Training in individuals with type 2 diabetes (HART-D), is to compare the effect of resistance training alone (RT), resistance in combination with aerobic training (AT+RT), and aerobic training alone (AT) to standard care (SC) on hemoglobin A1C (HbA1C), in initially sedentary women and men with type 2 diabetes (T2D).
Detailed description
Although it is generally accepted that regular exercise provides substantial health benefits to individuals with T2D, the exact exercise prescription in terms of type (AT versus RT versus AT+RT) still remains an important research issue, particularly in regard to week-to-week glucose control as assessed by HbA1C.
There is a need for more adequately powered and well-controlled studies to examine the effects of RT, AT and AT+RT on HbA1C in individuals with T2D. With the incidence of T2D expected to increase dramatically in the coming years, it is essential to have a better understanding of the relative benefits of various exercise interventions. This information can help better formulate exercise recommendations for patients with T2D as well as potentially provide more exercise options, which is important given the small percentage of individuals with TD2 who regularly exercise. The study group was sedentary women and men with T2D, aged 30 to 75 years. We randomly assigned 262 individuals to an aerobic exercise training only group (AT; n=72), a resistance training only group (RT; n=73), a combination of aerobic plus resistance training (AT+RT; n=76), or a standard care group (SC; n=41). The AT individuals participated in 3 or 4 training sessions each week for 9 months progressing to a total energy expenditure of 12 kcal/kg/week (KKW), which is an exercise dose consistent with the current public health recommendations for physical activity for individuals with T2D. The target exercise intensity was 50%-80% of baseline VO2 max. The RT group participated in 3 sessions per week (9 exercises, 2-3 sets each), which focuses on large muscle groups. This RT regimen is based on the studies that most successfully improved HbA1C in individuals with T2D. Individuals in the AT+RT group completed 10 KKW of aerobic training and a reduced resistance-training regimen of 2 sessions per week (9 exercises, 1 set of each). The AT+RT regimen represents the exercise recommendations of the American College of Sports Medicine (ACSM) and the American Diabetes Association (ADA).
Simply stated, we compared the effect of resistance training alone, resistance in combination with aerobic training, and aerobic training alone to standard care on HbA1C, in initially sedentary women and men with T2D. The primary outcome measure was HbA1C, an integrated measure of blood glucose control over the past 8-12 weeks. Other outcomes of interest included resting blood pressure, C-reactive protein (CRP), total body fat, and lean muscle mass as measured by DEXA, cardiorespiratory fitness, muscular strength, and metabolic measures including serum cholesterol and triglycerides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: exerciseWe randomly assigned 72 individuals to an aerobic exercise training only group. |
| 2 | Experimental | Behavioral: exerciseWe randomly assigned 73 individuals to an resistance exercise training only group. |
| 3 | Experimental | Behavioral: exerciseWe randomly assigned 76 individuals to a combination of aerobic plus resistance training group. |
| 4 | Placebo comparator | Behavioral: exerciseWe randomly assigned 41 individuals to a stretching and relaxation group. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 30-75 years
- type 2 diabetes determined by self-report with verification
- 6.5% < HbA1C < 11%
- sedentary lifestyle - not being physically active greater than or equal to 3 days per week for 20 minutes each time for the previous 6 months, and not performing regular resistance exercise
Key exclusion criteria (28 listed)
- inadequate control of co-morbid conditions
- resting blood pressure greater than or equal to 160/100 mm Hg
- Triglycerides greater than or equal to 500 mg/dL
- BMI is greater than or equal to 48
- current use of an insulin pump or insulin injections other than Lantus
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 |
|---|---|---|
| exercisecompared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching \& relaxing groups. | Behavioural | 1, 2, 3, 4 |
Primary outcome
Hemoglobin A1C
Time frame: at 9 months
9 secondary outcomes
Fasting glucose
Time frame: at 9 months
Basal insulin
Time frame: at 9 months
Resting blood pressure
Time frame: at 9 months
C reactive protein
Time frame: at 9 months
Visceral adiposity
Time frame: at 9 months
Body Composition
Time frame: at 9 months
Cardiorespiratory fitness
Time frame: at 9 months
Muscular strength
Time frame: at 9 months
metabolic measures, including serum cholesterol and triglycerides
Time frame: at 9 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 12502622Zinman B, Ruderman N, Campaigne BN, Devlin JT, Schneider SH; American Diabetes Association. Physical activity/exercise and diabetes mellitus. Diabetes Care. 2003 Jan;26 Suppl 1:S73-7. doi: 10.2337/diacare.26.2007.s73. No abstract available.
- Background: PubMed 10912903Albright 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.
- Background: PubMed 11727404Hamdy O, Goodyear LJ, Horton ES. Diet and exercise in type 2 diabetes mellitus. Endocrinol Metab Clin North Am. 2001 Dec;30(4):883-907. doi: 10.1016/s0889-8529(05)70220-6.
- Background: PubMed 11427776Kelley DE, Goodpaster BH. Effects of exercise on glucose homeostasis in Type 2 diabetes mellitus. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S495-501; discussion S528-9. doi: 10.1097/00005768-200106001-00020.
- Background: PubMed 12351468Nelson KM, Reiber G, Boyko EJ; NHANES III. Diet and exercise among adults with type 2 diabetes: findings from the third national health and nutrition examination survey (NHANES III). Diabetes Care. 2002 Oct;25(10):1722-8. doi: 10.2337/diacare.25.10.1722.
- Background: PubMed 11141143Khaw KT, Wareham N, Luben R, Bingham S, Oakes S, Welch A, Day N. Glycated haemoglobin, diabetes, and mortality in men in Norfolk cohort of european prospective investigation of cancer and nutrition (EPIC-Norfolk). BMJ. 2001 Jan 6;322(7277):15-8. doi: 10.1136/bmj.322.7277.15.
- Background: PubMed 9742976Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.
- Background: PubMed 11559268Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. doi: 10.1001/jama.286.10.1218.
- Background: PubMed 9702447Ishii T, Yamakita T, Sato T, Tanaka S, Fujii S. Resistance training improves insulin sensitivity in NIDDM subjects without altering maximal oxygen uptake. Diabetes Care. 1998 Aug;21(8):1353-5. doi: 10.2337/diacare.21.8.1353.
- Background: PubMed 12905089Baldi JC, Snowling N. Resistance training improves glycaemic control in obese type 2 diabetic men. Int J Sports Med. 2003 Aug;24(6):419-23. doi: 10.1055/s-2003-41173.
- Background: PubMed 12453982Castaneda C, Layne JE, Munoz-Orians L, Gordon PL, Walsmith J, Foldvari M, Roubenoff R, Tucker KL, Nelson ME. A randomized controlled trial of resistance exercise training to improve glycemic control in older adults with type 2 diabetes. Diabetes Care. 2002 Dec;25(12):2335-41. doi: 10.2337/diacare.25.12.2335.
- Background: PubMed 12351469Dunstan DW, Daly RM, Owen N, Jolley D, De Courten M, Shaw J, Zimmet P. High-intensity resistance training improves glycemic control in older patients with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1729-36. doi: 10.2337/diacare.25.10.1729.
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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.
Timothy S Church, MPH, MD, PhD principal investigator
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 exercise in people with Type 2 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 4 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?
Hemoglobin A1C (time frame: at 9 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 NCT00458133, which also lists 52 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.