Type 1 DiabetesEJB048NCT03174288
The Impact of Fitness and Mineralocorticoid Receptor Blockade on Vascular Dysfunction in Adults With Type 1 Diabetes
A study testing Exercise and Spironolactone in people with Type 1 Diabetes, run by University of Virginia at 1 site in United States.
Trial summary
In this protocol, 60 subjects with DM1 will be studied at baseline, after 12 weeks of MCR blockade or 12 weeks of exercise, and again after an additional 12 weeks of MCR blockade, exercise or the combination of both interventions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Exercise and Spironolactone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 22 May 2019
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 years
- BMI ≤30
- No clinically significant lab values other than those consistent with DM1
- Subjects will have been on insulin for at least 5 years and HbA1c <9
Who cannot join
- Smoking presently or in the past 6 months
- Medications that affect the vasculature (except ACE or ARB , although they will need to be off these drugs for 2 weeks prior to study).
- Elevated LDL cholesterol > 160
- BP <100/60 or >160/90
- Pulse oximetry <90%
- Pregnant or breastfeeding
Show all 13Show fewer
- History of cardiovascular disease, cerebral vascular disease, peripheral vascular disease, liver disease
- Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam).
- Known hypersensitivity to perflutren (contained in Definity)
- Serum Potassium ≥5.0
- HbA1c ≥ 9
- Retinopathy
- Ketoacidosis within the past year.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22906
About this study
In this protocol, 60 subjects with DM1 will be studied at baseline, after 12 weeks of MCR blockade or 12 weeks of exercise, and again after an additional 12 weeks of MCR blockade, exercise or the combination of both interventions. The investigators will assess function in conduit (pulse wave velocity-PWV, flow-mediated dilation-FMD and augmentation index-AI), resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular (contrast enhanced ultrasound-CEU) vessels before and after 2 hrs of a euglycemic insulin clamp.
We hypothesize that compared to healthy controls, both baseline and insulin-responsive vascular function are impaired throughout the arterial vasculature by DM1 and that exercise training and/or mineralocorticoid receptor (MCR) blockade will improve both baseline and insulin-responsive pan-arterial function.
Read the detailed description
Using non-invasive methods, several small studies have demonstrated conduit artery stiffness and other small studies report impaired brachial artery nitric oxide (NO) release in subjects with type diabetes (DM1). Vascular insulin action (characterized by insulin-induced NO-mediated vasodilation of conduit, resistance or microvascular vessels) has not been studied systematically in DM1. The investigators hypothesize that compared to healthy controls, both baseline and insulin-responsive vascular function are impaired throughout the arterial vasculature by DM1 and that exercise training and/or mineralocorticoid receptor (MCR) blockade will improve both baseline and insulin-responsive pan-arterial function.
In this protocol, 60 subjects with DM1 will be studied at baseline, after 12 weeks of MCR blockade or 12 weeks of exercise, and again after an additional 12 weeks of MCR blockade, exercise or the combination of both interventions. Investigators will assess function in conduit (pulse wave velocity-PWV, flow-mediated dilation-FMD and augmentation index-AI), resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular (contrast enhanced ultrasound-CEU) vessels before and after 2 hrs of a euglycemic insulin clamp.
This work will: a) identify whether vascular stiffness and indices of NO action are impaired throughout the arterial tree in DM1; b) identify the impact of fitness, MCR blockade or the combination to improve vascular function; and c) introduce a rational paradigm for early, proof-of-concept testing of interventions that may improve vascular health in DM1. While multiple endpoints are measured in the proposed studies, the investigators designate one primary conduit vessel endpoint (augmentation index) and one primary microvascular endpoint (microvascular blood volume by CEU); the studies are powered on these measures. The investigators believe that their laboratories are in a unique position with respect to their demonstrated scientific expertise to deliver this fundamental information.
The study proposed here will be the first to assess whether: 1) basal pan-arterial function including myocardial microvascular function is adversely affected by DM1 ; 2) vascular insulin responsiveness in DM1 is impaired as is seen in DM2 3) exercise training or MCR blockade alone or in combination favorably impacts vascular stiffness or NO-induced relaxation in DM1 in the basal state or in response to insulin. This non-invasive vascular profiling provides a functional "biomarker" of pan-arterial health. As such it could be useful for assessing the impact of specific short-term interventions on critical vascular functions in small scale studies (e.g. MCR blockade, statins, GLP-1R agonists) and thereby provide a rationale for selection of candidate therapies for subsequent larger clinical outcome trials. Additionally, non-invasive assessment of pan-arterial function could provide a platform to identify patients for early or more intensive treatment interventions as part of their care plan.
- Conditions
- Type 1 Diabetes
- Being tested
- Exercise, Spironolactone
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
24 weeks of exercise treatment
SpironolactoneDrug
24 weeks of spironolactone
| Study group | Role | What they receive |
|---|---|---|
| Exercise alone | Experimental | 24 weeks of exercise treatment Receives: Other: Exercise |
| spironolactone alone | Experimental | 24 weeks of Spironolactone treatment Receives: Drug: Spironolactone |
| Exercise + Spironolactone | Experimental | 24 weeks of exercise + Spironolactone treatment Receives: Other: Exercise; Drug: Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Augmentation Index-Change from baseline
measured at baseline and 24 weeks
Measured: 24 weeks
Secondary outcomes (5)
Flow Mediated Dilation-Change from baseline
measured at baseline and 24 weeks
Measured: 24 weeks
Pulse Wave Velocity-Change from baseline
measured at baseline and 24 weeks
Measured: 24 weeks
Post Ischemic Flow Velocity-Change from baseline
measured at baseline and 24 weeks
Measured: 24 weeks
Insulin Sensitivity-Change from baseline
measured by euglycemic insulin clamp at baseline and 24 weeks
Measured: 24 weeks
Microvascular Blood Volume-Change from baseline
measured at baseline and 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study startAug 2015
- Primary completion22 May 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (58)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugene Barrett, University of Virginia
- Investigators
- Eugene Barrett, MD, PhD, Principal investigator, University of Virginia, Dept of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174288
- Sponsor's protocol ID
- 18237
- Other IDs
- 5R01DK101944-03
- Acronym
- EJB048
- Status last verified
- Dec 2019
- First submitted
- 23 May 2017
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Soedamah-Muthu SS, Fuller JH, Mulnier HE, Raleigh VS, Lawrenson RA, Colhoun HM. All-cause mortality rates in patients with type 1 diabetes mellitus compared with a non-diabetic population from the UK general practice research database, 1992-1999. Diabetologia. 2006 Apr;49(4):660-6. doi: 10.1007/s00125-005-0120-4. Epub 2006 Jan 24.
PubMed 16432708Libby P, Nathan DM, Abraham K, Brunzell JD, Fradkin JE, Haffner SM, Hsueh W, Rewers M, Roberts BT, Savage PJ, Skarlatos S, Wassef M, Rabadan-Diehl C; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Report of the National Heart, Lung, and Blood Institute-National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Circulation. 2005 Jun 28;111(25):3489-93. doi: 10.1161/CIRCULATIONAHA.104.529651. No abstract available.
PubMed 15983263Krolewski AS, Kosinski EJ, Warram JH, Leland OS, Busick EJ, Asmal AC, Rand LI, Christlieb AR, Bradley RF, Kahn CR. Magnitude and determinants of coronary artery disease in juvenile-onset, insulin-dependent diabetes mellitus. Am J Cardiol. 1987 Apr 1;59(8):750-5. doi: 10.1016/0002-9149(87)91086-1.
PubMed 3825934Widlansky ME, Gokce N, Keaney JF Jr, Vita JA. The clinical implications of endothelial dysfunction. J Am Coll Cardiol. 2003 Oct 1;42(7):1149-60. doi: 10.1016/s0735-1097(03)00994-x.
PubMed 14522472Schram MT, Chaturvedi N, Schalkwijk CG, Fuller JH, Stehouwer CD; EURODIAB Prospective Complications Study Group. Markers of inflammation are cross-sectionally associated with microvascular complications and cardiovascular disease in type 1 diabetes--the EURODIAB Prospective Complications Study. Diabetologia. 2005 Feb;48(2):370-8. doi: 10.1007/s00125-004-1628-8. Epub 2005 Feb 4.
PubMed 15692810Johnstone MT, Creager SJ, Scales KM, Cusco JA, Lee BK, Creager MA. Impaired endothelium-dependent vasodilation in patients with insulin-dependent diabetes mellitus. Circulation. 1993 Dec;88(6):2510-6. doi: 10.1161/01.cir.88.6.2510.
PubMed 8080489Clarkson P, Celermajer DS, Donald AE, Sampson M, Sorensen KE, Adams M, Yue DK, Betteridge DJ, Deanfield JE. Impaired vascular reactivity in insulin-dependent diabetes mellitus is related to disease duration and low density lipoprotein cholesterol levels. J Am Coll Cardiol. 1996 Sep;28(3):573-9. doi: 10.1016/0735-1097(96)82380-1.
PubMed 8772741Boutouyrie P, Tropeano AI, Asmar R, Gautier I, Benetos A, Lacolley P, Laurent S. Aortic stiffness is an independent predictor of primary coronary events in hypertensive patients: a longitudinal study. Hypertension. 2002 Jan;39(1):10-5. doi: 10.1161/hy0102.099031.
PubMed 11799071Anderson TJ, Charbonneau F, Title LM, Buithieu J, Rose MS, Conradson H, Hildebrand K, Fung M, Verma S, Lonn EM. Microvascular function predicts cardiovascular events in primary prevention: long-term results from the Firefighters and Their Endothelium (FATE) study. Circulation. 2011 Jan 18;123(2):163-9. doi: 10.1161/CIRCULATIONAHA.110.953653. Epub 2011 Jan 3.
PubMed 21200002Schauer IE, Snell-Bergeon JK, Bergman BC, Maahs DM, Kretowski A, Eckel RH, Rewers M. Insulin resistance, defective insulin-mediated fatty acid suppression, and coronary artery calcification in subjects with and without type 1 diabetes: The CACTI study. Diabetes. 2011 Jan;60(1):306-14. doi: 10.2337/db10-0328. Epub 2010 Oct 26.
PubMed 20978091Laakso M, Edelman SV, Brechtel G, Baron AD. Decreased effect of insulin to stimulate skeletal muscle blood flow in obese man. A novel mechanism for insulin resistance. J Clin Invest. 1990 Jun;85(6):1844-52. doi: 10.1172/JCI114644.
PubMed 2189893Clerk LH, Vincent MA, Jahn LA, Liu Z, Lindner JR, Barrett EJ. Obesity blunts insulin-mediated microvascular recruitment in human forearm muscle. Diabetes. 2006 May;55(5):1436-42. doi: 10.2337/db05-1373.
PubMed 16644702Verma S, Buchanan MR, Anderson TJ. Endothelial function testing as a biomarker of vascular disease. Circulation. 2003 Oct 28;108(17):2054-9. doi: 10.1161/01.CIR.0000089191.72957.ED. No abstract available.
PubMed 14581384Barrett 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 21610226Keske MA, Clerk LH, Price WJ, Jahn LA, Barrett EJ. Obesity blunts microvascular recruitment in human forearm muscle after a mixed meal. Diabetes Care. 2009 Sep;32(9):1672-7. doi: 10.2337/dc09-0206. Epub 2009 Jun 1.
PubMed 19487636
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Fitness and Mineralocorticoid Receptor Blockade on Vascular Dysfunction in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03174288
- Acronym / sponsor ID
- EJB048 / 18237
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2015
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 2 Jun 2017 (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.
In this protocol, 60 subjects with DM1 will be studied at baseline, after 12 weeks of MCR blockade or 12 weeks of exercise, and again after an additional 12 weeks of MCR blockade, exercise or the combination of both interventions. The investigators will assess function in conduit (pulse wave velocity-PWV, flow-mediated dilation-FMD and augmentation index-AI), resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular (contrast enhanced ultrasound-CEU) vessels before and after 2 hrs of a euglycemic insulin clamp.
We hypothesize that compared to healthy controls, both baseline and insulin-responsive vascular function are impaired throughout the arterial vasculature by DM1 and that exercise training and/or mineralocorticoid receptor (MCR) blockade will improve both baseline and insulin-responsive pan-arterial function.
Detailed description
Using non-invasive methods, several small studies have demonstrated conduit artery stiffness and other small studies report impaired brachial artery nitric oxide (NO) release in subjects with type diabetes (DM1). Vascular insulin action (characterized by insulin-induced NO-mediated vasodilation of conduit, resistance or microvascular vessels) has not been studied systematically in DM1. The investigators hypothesize that compared to healthy controls, both baseline and insulin-responsive vascular function are impaired throughout the arterial vasculature by DM1 and that exercise training and/or mineralocorticoid receptor (MCR) blockade will improve both baseline and insulin-responsive pan-arterial function.
In this protocol, 60 subjects with DM1 will be studied at baseline, after 12 weeks of MCR blockade or 12 weeks of exercise, and again after an additional 12 weeks of MCR blockade, exercise or the combination of both interventions. Investigators will assess function in conduit (pulse wave velocity-PWV, flow-mediated dilation-FMD and augmentation index-AI), resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular (contrast enhanced ultrasound-CEU) vessels before and after 2 hrs of a euglycemic insulin clamp.
This work will: a) identify whether vascular stiffness and indices of NO action are impaired throughout the arterial tree in DM1; b) identify the impact of fitness, MCR blockade or the combination to improve vascular function; and c) introduce a rational paradigm for early, proof-of-concept testing of interventions that may improve vascular health in DM1. While multiple endpoints are measured in the proposed studies, the investigators designate one primary conduit vessel endpoint (augmentation index) and one primary microvascular endpoint (microvascular blood volume by CEU); the studies are powered on these measures. The investigators believe that their laboratories are in a unique position with respect to their demonstrated scientific expertise to deliver this fundamental information.
The study proposed here will be the first to assess whether: 1) basal pan-arterial function including myocardial microvascular function is adversely affected by DM1 ; 2) vascular insulin responsiveness in DM1 is impaired as is seen in DM2 3) exercise training or MCR blockade alone or in combination favorably impacts vascular stiffness or NO-induced relaxation in DM1 in the basal state or in response to insulin. This non-invasive vascular profiling provides a functional "biomarker" of pan-arterial health. As such it could be useful for assessing the impact of specific short-term interventions on critical vascular functions in small scale studies (e.g. MCR blockade, statins, GLP-1R agonists) and thereby provide a rationale for selection of candidate therapies for subsequent larger clinical outcome trials. Additionally, non-invasive assessment of pan-arterial function could provide a platform to identify patients for early or more intensive treatment interventions as part of their care plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise alone | Experimental | Other: Exercise24 weeks of exercise treatment |
| spironolactone alone | Experimental | Drug: Spironolactone24 weeks of Spironolactone treatment |
| Exercise + Spironolactone | Experimental | Other: Exercise, Drug: Spironolactone24 weeks of exercise + Spironolactone treatment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-50 years
- BMI ≤30
- No clinically significant lab values other than those consistent with DM1
- Subjects will have been on insulin for at least 5 years and HbA1c <9
Key exclusion criteria (13 listed)
- Smoking presently or in the past 6 months
- Medications that affect the vasculature (except ACE or ARB , although they will need to be off these drugs for 2 weeks prior to study).
- Elevated LDL cholesterol > 160
- BP <100/60 or >160/90
- Pulse oximetry <90%
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 |
|---|---|---|
| Exercise24 weeks of exercise treatment | Other | Exercise + Spironolactone, Exercise alone |
| Spironolactone24 weeks of spironolactone | Drug | Exercise + Spironolactone, spironolactone alone |
Primary outcome
Augmentation Index-Change from baseline
Time frame: 24 weeks
measured at baseline and 24 weeks
5 secondary outcomes
Flow Mediated Dilation-Change from baseline
Time frame: 24 weeks
Pulse Wave Velocity-Change from baseline
Time frame: 24 weeks
Post Ischemic Flow Velocity-Change from baseline
Time frame: 24 weeks
Insulin Sensitivity-Change from baseline
Time frame: 24 weeks
Microvascular Blood Volume-Change from baseline
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Background: PubMed 16432708Soedamah-Muthu SS, Fuller JH, Mulnier HE, Raleigh VS, Lawrenson RA, Colhoun HM. All-cause mortality rates in patients with type 1 diabetes mellitus compared with a non-diabetic population from the UK general practice research database, 1992-1999. Diabetologia. 2006 Apr;49(4):660-6. doi: 10.1007/s00125-005-0120-4. Epub 2006 Jan 24.
- Background: PubMed 15983263Libby P, Nathan DM, Abraham K, Brunzell JD, Fradkin JE, Haffner SM, Hsueh W, Rewers M, Roberts BT, Savage PJ, Skarlatos S, Wassef M, Rabadan-Diehl C; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Report of the National Heart, Lung, and Blood Institute-National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Circulation. 2005 Jun 28;111(25):3489-93. doi: 10.1161/CIRCULATIONAHA.104.529651. No abstract available.
- Background: PubMed 3825934Krolewski AS, Kosinski EJ, Warram JH, Leland OS, Busick EJ, Asmal AC, Rand LI, Christlieb AR, Bradley RF, Kahn CR. Magnitude and determinants of coronary artery disease in juvenile-onset, insulin-dependent diabetes mellitus. Am J Cardiol. 1987 Apr 1;59(8):750-5. doi: 10.1016/0002-9149(87)91086-1.
- Background: PubMed 14522472Widlansky ME, Gokce N, Keaney JF Jr, Vita JA. The clinical implications of endothelial dysfunction. J Am Coll Cardiol. 2003 Oct 1;42(7):1149-60. doi: 10.1016/s0735-1097(03)00994-x.
- Background: PubMed 15692810Schram MT, Chaturvedi N, Schalkwijk CG, Fuller JH, Stehouwer CD; EURODIAB Prospective Complications Study Group. Markers of inflammation are cross-sectionally associated with microvascular complications and cardiovascular disease in type 1 diabetes--the EURODIAB Prospective Complications Study. Diabetologia. 2005 Feb;48(2):370-8. doi: 10.1007/s00125-004-1628-8. Epub 2005 Feb 4.
- Background: PubMed 8080489Johnstone MT, Creager SJ, Scales KM, Cusco JA, Lee BK, Creager MA. Impaired endothelium-dependent vasodilation in patients with insulin-dependent diabetes mellitus. Circulation. 1993 Dec;88(6):2510-6. doi: 10.1161/01.cir.88.6.2510.
- Background: PubMed 8772741Clarkson P, Celermajer DS, Donald AE, Sampson M, Sorensen KE, Adams M, Yue DK, Betteridge DJ, Deanfield JE. Impaired vascular reactivity in insulin-dependent diabetes mellitus is related to disease duration and low density lipoprotein cholesterol levels. J Am Coll Cardiol. 1996 Sep;28(3):573-9. doi: 10.1016/0735-1097(96)82380-1.
- Background: PubMed 11799071Boutouyrie P, Tropeano AI, Asmar R, Gautier I, Benetos A, Lacolley P, Laurent S. Aortic stiffness is an independent predictor of primary coronary events in hypertensive patients: a longitudinal study. Hypertension. 2002 Jan;39(1):10-5. doi: 10.1161/hy0102.099031.
- Background: PubMed 21200002Anderson TJ, Charbonneau F, Title LM, Buithieu J, Rose MS, Conradson H, Hildebrand K, Fung M, Verma S, Lonn EM. Microvascular function predicts cardiovascular events in primary prevention: long-term results from the Firefighters and Their Endothelium (FATE) study. Circulation. 2011 Jan 18;123(2):163-9. doi: 10.1161/CIRCULATIONAHA.110.953653. Epub 2011 Jan 3.
- Background: PubMed 20978091Schauer IE, Snell-Bergeon JK, Bergman BC, Maahs DM, Kretowski A, Eckel RH, Rewers M. Insulin resistance, defective insulin-mediated fatty acid suppression, and coronary artery calcification in subjects with and without type 1 diabetes: The CACTI study. Diabetes. 2011 Jan;60(1):306-14. doi: 10.2337/db10-0328. Epub 2010 Oct 26.
- Background: PubMed 2189893Laakso M, Edelman SV, Brechtel G, Baron AD. Decreased effect of insulin to stimulate skeletal muscle blood flow in obese man. A novel mechanism for insulin resistance. J Clin Invest. 1990 Jun;85(6):1844-52. doi: 10.1172/JCI114644.
- Background: PubMed 16644702Clerk LH, Vincent MA, Jahn LA, Liu Z, Lindner JR, Barrett EJ. Obesity blunts insulin-mediated microvascular recruitment in human forearm muscle. Diabetes. 2006 May;55(5):1436-42. doi: 10.2337/db05-1373.
- 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.
Eugene Barrett, MD, PhD principal investigator
University of Virginia, Dept of Endocrinology
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 and Spironolactone in people with Type 1 Diabetes, 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 4 inclusion and 13 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 18 Dec 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?
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?
Augmentation Index-Change from baseline (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03174288, which also lists 58 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 18 Dec 2019.