Metabolic SyndromeNCT03894527
Impact of Acute Exercise on Vascular Insulin Sensitivity in Metabolic Syndrome
A study testing Single Bout of Exercise in people with Metabolic Syndrome and Obesity, run by University of Virginia at 1 site in United States.
Trial summary
Obesity is an independent risk factor for type 2 diabetes and cardiovascular disease. The increased prevalence of obesity worldwide is a major concern among the scientific and medical communities. Insulin resistance is a common factor associated with obesity, metabolic syndrome, hypertension, and type 2 diabetes. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- Single Bout of Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2019to 31 Jan 2020
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, ages 40-70 years
- Never diagnosed with type 2 diabetes and/or cardiovascular disease
- Not currently engaged in > 60 min/wk of exercise
- Inclusion criteria specific to health obese vs. metabolic syndrome potential participants:
- Healthy Obese: (BMI ≥ 30 kg/m2 but ≤ 45 kg/m2) and no other metabolic syndrome risk factors, excluding waist circumference.
- Metabolic Syndrome: (BMI ≥ 30 kg/m2 but ≤ 45 kg/m2) and must meet at least 3 out of 5 National Cholesterol Education Adult Treatment Panel III Metabolic Syndrome Criteria:
Show all 10Show fewer
- Increased waist circumference (≥102 cm in men; ≥88 cm in women) Elevated triglycerides (≥150 mg/dl) or currently taking medication (Rx) Reduced HDL-cholesterol (<40mg/dl in men, <50 mg/dl in women) or currently taking medication (Rx) High blood pressure (≥130 mmHg systolic or ≥85mmHg diastolic) or currently taking medication (Rx) Elevated fasting glucose (≥100 mg/dl)
- Subject may participate if on the following drugs:
- Diuretics, ace-inhibitors and ARBs for treatment of hypertension
- Statins
Who cannot join
- Morbidly obese patients (BMI >45 kg/m2) and overweight/lean patients (BMI <30 kg/m2).
- Subjects who have not been weight stable (>2kg weight change in past 3 months).
- Currently participating in a regular exercise training program ( >30 min. of physical activity per day, >2 days/week)
- Medication or food supplement that is known to affect insulin sensitivity or endothelial function (TZDs, sulfonylureas, biguanides, alpha-glucosidase inhibitors, phosphodiesterase inhibitors, beta-blockers, alpha-blockers, fibrates, glucocorticoids, fish oil, allopurinol)
- Subjects with abnormal estimated glomerular filtration rate (eGFR).
- Hypertriglyceridemic (>400 mg/dl) subjects.
Show all 15Show fewer
- Hypertensive (>160/100 mmHg)
- Subjects taking vasoactive medications also known to affect heart rate and rhythm (i.e. Ca++ channel blockers, nitrates, alpha- or beta-blockers).
- Subjects with a history of significant metabolic, cardiac, congestive heart failure, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer that in the investigator's opinion would interfere with or alter the outcome measures, or impact subject safety.
- Smoking presently or in the past 1 year.
- HbA1c ≥ 6.5
- Subjects currently taking Metformin or any active weight suppression medication (e.g. phentermine, orlistat, lorcaserin, naltrexone-bupropion in combination, liraglutide, benzphetamine, diethylpropion, phendimetrazine)
- Pregnant (as evidenced by positive pregnancy test) or breastfeeding
- Subjects with contraindications to participation in an exercise program
- Known hypersensitivity to perflutren (contained in Definity)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22904
Emily Heiston, M.Ed., 434-243-8677, emh5bh@virginia.edu
Stephanie Miller, M.Ed., 434-243-8677, slm4ps@virginia.edu
About this study
Obesity is an independent risk factor for type 2 diabetes and cardiovascular disease. The increased prevalence of obesity worldwide is a major concern among the scientific and medical communities. Insulin resistance is a common factor associated with obesity, metabolic syndrome, hypertension, and type 2 diabetes. Individuals affected by these conditions often experience endothelial dysfunction as well. Insulin resistance provides a key link between metabolic syndrome risk factors and vascular disease. Development of strategies aimed at preventing vascular dysfunction and future disease caused by metabolic disturbances is needed. Although the relationship between obesity and various diseases is well known, the acute effects of insulin on vascular function in obese individuals have yet to be fully determined. Additionally, the effects of acute exercise on insulin-stimulated endothelial function are unknown. Exercise may be an effective and potent treatment that protects against endothelial dysfunction, insulin resistance, and future cardiometabolic disease commonly present with obesity. However, less attention has been placed on vascular insulin sensitivity. The purpose of this study is to test the hypothesis that a single bout of exercise increases insulin-stimulated blood flow at the macro- and micro-vasculature level in obese individuals with metabolic syndrome to similar levels as healthy obese control. Our laboratory has available non-invasive methods to quantify vascular function and the gold-standard technique for assessing insulin sensitivity (euglycemic-hyperinsulinemic clamp). The investigators will assess vascular function (flow-mediated dilation, post-ischemic flow velocity and contrast-enhanced ultrasound) as well as arterial stiffness (augmentation index and pulse wave velocity) before and at the end of the clamp protocol performed the morning following a bout of exercise and a control (no-exercise) condition in 1) metabolic syndrome and 2) obese adults. If our hypothesis is sustained, it will suggest that a key role of the vasculature exists in regulating insulin following exercise and will provide insight into the link between the vasculature, obesity, metabolic syndrome and cardiovascular disease and may confer decreased risk for cardiometabolic disease.
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- Single Bout of Exercise, Control Condition
- Keywords
- Acute Exercise, Endothelial Function, Simple Obesity, Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Bout of ExerciseBehavioural
An exercise condition, which will be walking at a moderate intensity (~70% VO2peak). Time will vary based upon individual fitness levels to burn ~400kcals (estimated 0.5 - 1hr). Oxygen consumption will be measured during exercise via a metabolic cart to confirm energy expenditure. Participants will then rest following the exercise procedure for 20 minutes. Between 20 and 45 minutes following exercise, oxygen consumption will be measured to understand and capture excess post-exercise oxygen consumption (EPOC). Following this, participants will be provided with a standardize dinner and snack to consume in the AMP lab.
Control ConditionBehavioural
A control (no-exercise) condition. Participants will report to the AMP lab to rest for the same duration as the exercise bout and consume the standardized dinner and snack.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Subjects with simple obesity will complete 2 different testing conditions in a counterbalanced order with at least one week between conditions.
10-12 hrs post test condition the subject will report for a Euglycemic-Hyperinsulinemic clamp study, where Flow Mediated Dilation (FMD) and Contrast Enhanced Ultrasound (CEU) will be performed. Receives: Behavioral: Single Bout of Exercise; Behavioral: Control Condition |
| Metabolic Syndrome | Active comparator | Subjects with metabolic syndrome will complete 2 different testing conditions in a counterbalanced order with at least one week between conditions.
10-12 hrs post test condition the subject will report for a Euglycemic-Hyperinsulinemic clamp study, where Flow Mediated Dilation (FMD) and Contrast Enhanced Ultrasound (CEU) will be performed. Receives: Behavioral: Single Bout of Exercise; Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of single bout of exercise on FMD
Flow Mediated Dilation (FMD) as a percentage
Measured: Baseline clamp study
Effect of single bout of exercise on CEU
Contrast Enhanced Ultrasound (CEU) as a percentage
Measured: Baseline Clamp Study
Comparison of insulin stimulated FMD response
Flow mediated dilation as a percentage of fasting values
Measured: Through study completion, up to about 4 weeks
Comparison of insulin stimulated CEU response
Contrast Enhanced Ultrasound (CEU) as a percentage of fasting values
Measured: Through study completion, up to about 4 weeks
Secondary outcomes (7)
Systemic Arterial stiffness
Augmentation Index as a percentage
Measured: Through study completion, up to about 4 weeks
Central Arterial Stiffness
Pulse wave velocity in m/s
Measured: Through study completion, up to about 4 weeks
Metabolic Flexibility
Respiratory gases in fasted and insulin-stimulated states in arbitrary units
Measured: Through study completion, up to about 4 weeks
Fasting glucose
Comparison of glucose collected at baseline in mg/dl
Measured: Through study completion, up to about 4 weeks
Fasting insulin
Comparison of insulin collected at baseline in uU/ml
Measured: Through study completion, up to about 4 weeks
Free Fatty Acids
Comparison of free fatty acids collected at baseline in mEq/L
Measured: Through study completion, up to about 4 weeks
Adiponectin
Comparison of inflammatory in ng/ml
Measured: Through study completion, up to about 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start18 Feb 2019
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Sports Medicine
- Responsible party
- Principal investigator, Steven K. Malin, PhD, University of Virginia
- Investigators
- Steve Malin, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894527
- Sponsor's protocol ID
- 19060
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moore JX, Chaudhary N, Akinyemiju T. Metabolic Syndrome Prevalence by Race/Ethnicity and Sex in the United States, National Health and Nutrition Examination Survey, 1988-2012. Prev Chronic Dis. 2017 Mar 16;14:E24. doi: 10.5888/pcd14.160287.
PubMed 28301314Huang PL. A comprehensive definition for metabolic syndrome. Dis Model Mech. 2009 May-Jun;2(5-6):231-7. doi: 10.1242/dmm.001180.
PubMed 19407331Roberts CK, Hevener AL, Barnard RJ. Metabolic syndrome and insulin resistance: underlying causes and modification by exercise training. Compr Physiol. 2013 Jan;3(1):1-58. doi: 10.1002/cphy.c110062.
PubMed 23720280Barrett EJ, Liu Z. The endothelial cell: an "early responder" in the development of insulin resistance. Rev Endocr Metab Disord. 2013 Mar;14(1):21-7. doi: 10.1007/s11154-012-9232-6.
PubMed 23306779Goodpaster BH, Sparks LM. Metabolic Flexibility in Health and Disease. Cell Metab. 2017 May 2;25(5):1027-1036. doi: 10.1016/j.cmet.2017.04.015.
PubMed 28467922DeFronzo RA, Sherwin RS, Kraemer N. Effect of physical training on insulin action in obesity. Diabetes. 1987 Dec;36(12):1379-85. doi: 10.2337/diab.36.12.1379.
PubMed 3315786Morrish NJ, Wang SL, Stevens LK, Fuller JH, Keen H. Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001 Sep;44 Suppl 2:S14-21. doi: 10.1007/pl00002934.
PubMed 11587045Barrett EJ, Wang H, Upchurch CT, Liu Z. Insulin regulates its own delivery to skeletal muscle by feed-forward actions on the vasculature. Am J Physiol Endocrinol Metab. 2011 Aug;301(2):E252-63. doi: 10.1152/ajpendo.00186.2011. Epub 2011 May 24.
PubMed 21610226Barrett EJ, Eggleston EM, Inyard AC, Wang H, Li G, Chai W, Liu Z. The vascular actions of insulin control its delivery to muscle and regulate the rate-limiting step in skeletal muscle insulin action. Diabetologia. 2009 May;52(5):752-64. doi: 10.1007/s00125-009-1313-z. Epub 2009 Mar 13.
PubMed 19283361Inyard AC, Clerk LH, Vincent MA, Barrett EJ. Contraction stimulates nitric oxide independent microvascular recruitment and increases muscle insulin uptake. Diabetes. 2007 Sep;56(9):2194-200. doi: 10.2337/db07-0020. Epub 2007 Jun 11.
PubMed 17563063Muniyappa R, Yavuz S. Metabolic actions of angiotensin II and insulin: a microvascular endothelial balancing act. Mol Cell Endocrinol. 2013 Sep 25;378(1-2):59-69. doi: 10.1016/j.mce.2012.05.017. Epub 2012 Jun 7.
PubMed 22684034Zhao Y, Vanhoutte PM, Leung SW. Vascular nitric oxide: Beyond eNOS. J Pharmacol Sci. 2015 Oct;129(2):83-94. doi: 10.1016/j.jphs.2015.09.002. Epub 2015 Sep 28.
PubMed 26499181Jahn LA, Hartline L, Rao N, Logan B, Kim JJ, Aylor K, Gan LM, Westergren HU, Barrett EJ. Insulin Enhances Endothelial Function Throughout the Arterial Tree in Healthy But Not Metabolic Syndrome Subjects. J Clin Endocrinol Metab. 2016 Mar;101(3):1198-206. doi: 10.1210/jc.2015-3293. Epub 2016 Jan 12.
PubMed 26756115Reynolds LJ, Credeur DP, Manrique C, Padilla J, Fadel PJ, Thyfault JP. Obesity, type 2 diabetes, and impaired insulin-stimulated blood flow: role of skeletal muscle NO synthase and endothelin-1. J Appl Physiol (1985). 2017 Jan 1;122(1):38-47. doi: 10.1152/japplphysiol.00286.2016. Epub 2016 Oct 27.
PubMed 27789766Penedo FJ, Dahn JR. Exercise and well-being: a review of mental and physical health benefits associated with physical activity. Curr Opin Psychiatry. 2005 Mar;18(2):189-93. doi: 10.1097/00001504-200503000-00013.
PubMed 16639173
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acute Exercise on Vascular Insulin Sensitivity in Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03894527
- Acronym / sponsor ID
- 19060
- Conditions
- Metabolic Syndrome, Obesity
- Keywords
- Acute Exercise, Endothelial Function, Simple Obesity, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- American College of Sports Medicine
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 28 Mar 2019 (actual)
- 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.
Obesity is an independent risk factor for type 2 diabetes and cardiovascular disease. The increased prevalence of obesity worldwide is a major concern among the scientific and medical communities. Insulin resistance is a common factor associated with obesity, metabolic syndrome, hypertension, and type 2 diabetes. Individuals affected by these conditions often experience endothelial dysfunction as well. Insulin resistance provides a key link between metabolic syndrome risk factors and vascular disease. Development of strategies aimed at preventing vascular dysfunction and future disease caused by metabolic disturbances is needed. Although the relationship between obesity and various diseases is well known, the acute effects of insulin on vascular function in obese individuals have yet to be fully determined. Additionally, the effects of acute exercise on insulin-stimulated endothelial function are unknown. Exercise may be an effective and potent treatment that protects against endothelial dysfunction, insulin resistance, and future cardiometabolic disease commonly present with obesity. However, less attention has been placed on vascular insulin sensitivity. The purpose of this study is to test the hypothesis that a single bout of exercise increases insulin-stimulated blood flow at the macro- and micro-vasculature level in obese individuals with metabolic syndrome to similar levels as healthy obese control. Our laboratory has available non-invasive methods to quantify vascular function and the gold-standard technique for assessing insulin sensitivity (euglycemic-hyperinsulinemic clamp). The investigators will assess vascular function (flow-mediated dilation, post-ischemic flow velocity and contrast-enhanced ultrasound) as well as arterial stiffness (augmentation index and pulse wave velocity) before and at the end of the clamp protocol performed the morning following a bout of exercise and a control (no-exercise) condition in 1) metabolic syndrome and 2) obese adults. If our hypothesis is sustained, it will suggest that a key role of the vasculature exists in regulating insulin following exercise and will provide insight into the link between the vasculature, obesity, metabolic syndrome and cardiovascular disease and may confer decreased risk for cardiometabolic disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Single Bout of Exercise, Behavioral: Control ConditionSubjects with simple obesity will complete 2 different testing conditions in a counterbalanced order with at least one week between conditions. 10-12 hrs post test condition the subject will report for a Euglycemic-Hyperinsulinemic clamp study, where Flow Mediated Dilation (FMD) and Contrast Enhanced Ultrasound (CEU) will be performed. |
| Metabolic Syndrome | Active comparator | Behavioral: Single Bout of Exercise, Behavioral: Control ConditionSubjects with metabolic syndrome will complete 2 different testing conditions in a counterbalanced order with at least one week between conditions. 10-12 hrs post test condition the subject will report for a Euglycemic-Hyperinsulinemic clamp study, where Flow Mediated Dilation (FMD) and Contrast Enhanced Ultrasound (CEU) will be performed. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females, ages 40-70 years
- Never diagnosed with type 2 diabetes and/or cardiovascular disease
- Not currently engaged in > 60 min/wk of exercise
- Inclusion criteria specific to health obese vs. metabolic syndrome potential participants:
- Increased waist circumference (≥102 cm in men; ≥88 cm in women) Elevated triglycerides (≥150 mg/dl) or currently taking medication (Rx) Reduced HDL-cholesterol (<40mg/dl in men, <50 mg/dl in women) or currently taking medication (Rx) High blood pressure (≥130 mmHg systolic or ≥85mmHg diastolic) or currently taking medication (Rx) Elevated fasting glucose (≥100 mg/dl)
Key exclusion criteria (15 listed)
- Morbidly obese patients (BMI >45 kg/m2) and overweight/lean patients (BMI <30 kg/m2).
- Subjects who have not been weight stable (>2kg weight change in past 3 months).
- Currently participating in a regular exercise training program ( >30 min. of physical activity per day, >2 days/week)
- Medication or food supplement that is known to affect insulin sensitivity or endothelial function (TZDs, sulfonylureas, biguanides, alpha-glucosidase inhibitors, phosphodiesterase inhibitors, beta-blockers, alpha-blockers, fibrates, glucocorticoids, fish oil, allopurinol)
- Subjects with abnormal estimated glomerular filtration rate (eGFR).
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 |
|---|---|---|
| Single Bout of ExerciseAn exercise condition, which will be walking at a moderate intensity (~70% VO2peak). Time will vary based upon individual fitness levels to burn ~400kcals (estimated 0.5 - 1hr). Oxygen consumption will be measured during exercise via a metabolic cart to confirm energy expenditure. Participants will then rest following the exercise procedure for 20 minutes. Between 20 and 45 minutes following exercise, oxygen consumption will be measured to understand and capture excess post-exercise oxygen consumption (EPOC). Following this, participants will be provided with a standardize dinner and snack to consume in the AMP lab. | Behavioural | Control, Metabolic Syndrome |
| Control ConditionA control (no-exercise) condition. Participants will report to the AMP lab to rest for the same duration as the exercise bout and consume the standardized dinner and snack. | Behavioural | Control, Metabolic Syndrome |
Primary outcome
Effect of single bout of exercise on FMD
Time frame: Baseline clamp study
Flow Mediated Dilation (FMD) as a percentage
Effect of single bout of exercise on CEU
Time frame: Baseline Clamp Study
Contrast Enhanced Ultrasound (CEU) as a percentage
Comparison of insulin stimulated FMD response
Time frame: Through study completion, up to about 4 weeks
Flow mediated dilation as a percentage of fasting values
Comparison of insulin stimulated CEU response
Time frame: Through study completion, up to about 4 weeks
Contrast Enhanced Ultrasound (CEU) as a percentage of fasting values
7 secondary outcomes
Systemic Arterial stiffness
Time frame: Through study completion, up to about 4 weeks
Central Arterial Stiffness
Time frame: Through study completion, up to about 4 weeks
Metabolic Flexibility
Time frame: Through study completion, up to about 4 weeks
Fasting glucose
Time frame: Through study completion, up to about 4 weeks
Fasting insulin
Time frame: Through study completion, up to about 4 weeks
Free Fatty Acids
Time frame: Through study completion, up to about 4 weeks
Adiponectin
Time frame: Through study completion, up to about 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Background: PubMed 28301314Moore JX, Chaudhary N, Akinyemiju T. Metabolic Syndrome Prevalence by Race/Ethnicity and Sex in the United States, National Health and Nutrition Examination Survey, 1988-2012. Prev Chronic Dis. 2017 Mar 16;14:E24. doi: 10.5888/pcd14.160287.
- Background: PubMed 19407331Huang PL. A comprehensive definition for metabolic syndrome. Dis Model Mech. 2009 May-Jun;2(5-6):231-7. doi: 10.1242/dmm.001180.
- Background: PubMed 23720280Roberts CK, Hevener AL, Barnard RJ. Metabolic syndrome and insulin resistance: underlying causes and modification by exercise training. Compr Physiol. 2013 Jan;3(1):1-58. doi: 10.1002/cphy.c110062.
- Background: PubMed 23306779Barrett EJ, Liu Z. The endothelial cell: an "early responder" in the development of insulin resistance. Rev Endocr Metab Disord. 2013 Mar;14(1):21-7. doi: 10.1007/s11154-012-9232-6.
- Background: PubMed 28467922Goodpaster BH, Sparks LM. Metabolic Flexibility in Health and Disease. Cell Metab. 2017 May 2;25(5):1027-1036. doi: 10.1016/j.cmet.2017.04.015.
- Background: PubMed 3315786DeFronzo RA, Sherwin RS, Kraemer N. Effect of physical training on insulin action in obesity. Diabetes. 1987 Dec;36(12):1379-85. doi: 10.2337/diab.36.12.1379.
- Background: PubMed 11587045Morrish NJ, Wang SL, Stevens LK, Fuller JH, Keen H. Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001 Sep;44 Suppl 2:S14-21. doi: 10.1007/pl00002934.
- Background: PubMed 21610226Barrett EJ, Wang H, Upchurch CT, Liu Z. Insulin regulates its own delivery to skeletal muscle by feed-forward actions on the vasculature. Am J Physiol Endocrinol Metab. 2011 Aug;301(2):E252-63. doi: 10.1152/ajpendo.00186.2011. Epub 2011 May 24.
- Background: PubMed 19283361Barrett EJ, Eggleston EM, Inyard AC, Wang H, Li G, Chai W, Liu Z. The vascular actions of insulin control its delivery to muscle and regulate the rate-limiting step in skeletal muscle insulin action. Diabetologia. 2009 May;52(5):752-64. doi: 10.1007/s00125-009-1313-z. Epub 2009 Mar 13.
- Background: PubMed 17563063Inyard AC, Clerk LH, Vincent MA, Barrett EJ. Contraction stimulates nitric oxide independent microvascular recruitment and increases muscle insulin uptake. Diabetes. 2007 Sep;56(9):2194-200. doi: 10.2337/db07-0020. Epub 2007 Jun 11.
- Background: PubMed 22684034Muniyappa R, Yavuz S. Metabolic actions of angiotensin II and insulin: a microvascular endothelial balancing act. Mol Cell Endocrinol. 2013 Sep 25;378(1-2):59-69. doi: 10.1016/j.mce.2012.05.017. Epub 2012 Jun 7.
- Background: PubMed 26499181Zhao Y, Vanhoutte PM, Leung SW. Vascular nitric oxide: Beyond eNOS. J Pharmacol Sci. 2015 Oct;129(2):83-94. doi: 10.1016/j.jphs.2015.09.002. Epub 2015 Sep 28.
- Individual participant dataSharing planned: No
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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.
Steve Malin, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Bout of Exercise in people with Metabolic Syndrome and Obesity, run by University of Virginia 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 10 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 28 Mar 2019. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emily Heiston, M.Ed. (434-243-8677, emh5bh@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of single bout of exercise on FMD (time frame: Baseline clamp study). The study lists 4 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 NCT03894527, which also lists 27 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 28 Mar 2019.