Insulin SensitivityNCT03325933
Resistance Training and Cardiometabolic Health
A study testing High Load/Low Rep Resistance Training and Low Load/High Rep Resistance Training in people with Insulin Sensitivity and Endothelial Dysfunction, run by Arizona State University at 1 site in United States.
Trial summary
This study will investigate the relationship between resistance training load and repetitions on cardiometabolic outcomes. The primary objective of this clinical trial is to determine whether high load or low load resistance exercise training affects arterial stiffness in overweight or obese men and women. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Endothelial Dysfunction, Blood Pressure
- What is being tested?
- High Load/Low Rep Resistance Training and Low Load/High Rep Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2017to 31 Aug 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female
- 18-55 years of age
- BMI 25-40
- No recent history of starting a structured exercise program or diet in the last 3 months
Who cannot join
- Current smoker and/or recreational drug user
- Answers "yes" to one or more questions on the Physical Activity Readiness Questionnaire
- Diagnosed diabetes, heart disease
- History of anabolic steroid use in the past six months
- Taking medications for treatment of diabetes, heart disease, and hypertension.
- Orthopedic or musculoskeletal contraindications to resistance training
- Unwilling to follow any aspect of the study protocol including blood sampling and weight training
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the relationship between resistance training load and repetitions on cardiometabolic outcomes. The primary objective of this clinical trial is to determine whether high load or low load resistance exercise training affects arterial stiffness in overweight or obese men and women. Our secondary objectives are to investigate the effects of high and low load RT on vascular function, cardiac structure, and markers of insulin sensitivity. Finally, we are going to preliminarily explore the effects of resistance training on intestinal bacteria.
Read the detailed description
While it has been firmly established that aerobic exercise training is an effective modality for managing cardiometabolic disease risk, the influence of resistance training (RT) is not as well characterized. It is well established that RT improves muscular strength, size, cross sectional area, and bone mineral density. Alterations in muscle fiber type, glycolytic and oxidative enzyme profile, skeletal muscle proteins, and rates of protein synthesis also occur in response to RT and are obtained from skeletal muscle biopsies. Data from quasi-experimental studies suggest that moderate-to-high repetition RT with lower training loads may positively affect skeletal muscle proteins (Glucose Transporter Type 4 (GLUT4), Hexokinase 2 (HK2), and Adenylate kinase 2 (AK2) involved in insulin signaling in non-diabetic, obese men. However, data on high load, low rep RT on these variables is lacking. Thus, we will collect skeletal muscle biopsies to determine if changes in insulin signaling skeletal muscle proteins are present in response to both training with both high and low training loads. There is also a body of evidence suggesting that RT may improve VO2peak values in individuals with low baseline VO2peak values via a possible increase in capillary density, however, results are currently mixed. Low VO2peak values in overweight and obese individuals are positively associated with high risk of cardiovascular and all-cause mortality. Thus, we will measure VO2peak values to determine if (A) starting previously untrained obese individuals with RT can also improve VO2peak and (B) potential changes in VO2peak are load dependent. RT has also been reported to improve insulin sensitivity and central pressure. Additionally, aerobic exercise training may positively influence alterations in the intestinal microbiome, with no currently available evidence on the effects of RT, Although RT has been shown to be beneficial for improving arterial stiffness and insulin sensitivity, most of the available literature is based on protocols prescribing moderate-to-high repetitions and thus lower training loads. Thus, the effects of prescribing higher training loads on the aforementioned variables are not fully understood.
Increased arterial stiffness (as characterized by carotid-femoral pulse wave velocity (PWV) and augmentation index) is a clinical marker for cardiovascular disease and an independent risk factor for adverse cardiovascular events and all-cause mortality. Increased arterial stiffness has is positively associated with insulin resistance and type II diabetes. In the early stages of insulin resistance, peripheral insulin action, which occurs primarily in the skeletal muscle is impaired. This leads to a compensatory increase in insulin release in order to maintain glucose homeostasis, thus leading to hypertrophy of the pancreatic β cells. During the early stages of insulin resistance, fasting glucose levels will remain normal, with hyperglycemia manifesting in the later stages. Chronic hyperinsulinemia and hyperglycemia in turn cause increases in the renin-angiotensin aldosterone system as well expression of the angiotensin type I receptor in vascular tissue, thus stimulating VSMC proliferation, which leads to an increase in arterial stiffness. Chronic hyperglycemia and/or type II diabetes can lead to an increase in the production of advanced glycation end products (AGEs), which are proteins or lipids that become glycated due to exposure to glucose. Excessive production of AGEs can lead to an increase in collagen cross linking in the vascular walls, which thus leads to an increase in arterial stiffness.
Thus, it appears that increases in arterial stiffness occur due to perturbations in pulsatile shear and flow, which leads to abnormal turnover of scaffolding proteins, specifically excessive collagen production, and the proliferation of VSMCs, which results in a stiffer vasculature. This is exacerbated by the insulin resistant and/or hyperglycemic state due to an increase in local activity of the RAAS and expression of angiotensin I receptor activation in the vascular wall and an increase in age production, which leads to an increase in VSMCs and collagen cross-linking, respectively, thus further contributing to the development of a stiffer vasculature. These structural changes can have deleterious downstream consequences that include ischemic heart disease, myocardial infarction, and heart failure.
Current studies on the effects of RT on arterial stiffness have reported mixed results. It has been suggested that training with higher loads may cause greater increases in stiffness than training with lower loads due to greater acute elevations in blood pressure that occur with high load RT. Case control studies have reported that resistance trained young and middle aged non obese men demonstrated higher levels of arterial stiffness when compared to their aged-matched counterparts. Alternative cross-sectional studies reported that muscular strength was inversely related with arterial stiffness. Follow-up randomized control trials (RCT) investigated changes in arterial stiffness after several months of RT in non-obese, resistance training naïve adults. Improvements in central pressure, in the absence of changes in PWV, have been reported in non-diabetic obese adults after 12 weeks of RT but the study lacked an effective control group. Additionally, improvements in insulin sensitivity in non-diabetic obese males after 12 weeks of RT but was not a randomized controlled trial (RCT). Improvements in endothelial function has also been reported after six months of progressive RT that included both moderate and high training loads. This is significant because endothelial dysfunction is a downstream consequence of increased arterial stiffness, and thus an improvement in endothelial function, as measured by relative flow mediated dilation (%FMD), in response to RT is a reflects an improvement in vascular function, which is unlikely to occur in conjunction with an increase in vascular stiffness. To our knowledge, there are no current published RCTs on the effects of high load RT that have measured both arterial stiffness and endothelial function. This study will follow up on previous studies by comparing the effects of two distinct RT protocols (high load vs low load) on arterial stiffness as, measured by PWV and augmentation index, and endothelial function, as measured by %FMD, to a nonexercising control group.
A body of literature exists to suggest that morphological changes of the left ventricle take place in response to resistance training. Case control studies have reported that elite resistance trained athletes demonstrate evidence of left ventricular wall thickening. The increase in left ventricular wall thickness is referred to as concentric hypertrophy, which occurs in response to a chronic increase in afterload. This occurs in the presence of increased arterial stiffness, uncontrolled hypertension, and aortic stenosis, all of which can lead to heart failure (HF). RT induced concentric hypertrophy appears to be a physiological training adaptation, similar to the eccentric hypertrophy that takes place in response to aerobic training, and thus does not appear to be deleterious. Furthermore, current RCTs on the effects of RT on morphological changes of the LV suggest that this adaptation does not always occur or may occur in response to specific training volumes, frequencies, intensities, and/or over a longer training duration. Since the main outcome of this study is arterial stiffness, which is a precursor for concentric hypertrophy of the LV, we will also measure left ventricular wall thickness to see if A) morphological changes in the LV take place and B) if LV morphological changes are influenced by training load.
Thus, it appears that moderate training loads are shown to improve insulin sensitivity in obese individuals. This is significant because insulin resistance is a precursor to increases in arterial stiffness. However, the effects of training with higher loads on insulin sensitivity is a current gap in the literature. It has been previously proposed that high load RT may reduce arterial compliance and/or lead to concentric hypertrophy of the left ventricular walls. However, current evidence suggests that both moderate and high training loads improve endothelial function, without negatively affecting the left ventricular wall. Since endothelial dysfunction is a negative downstream consequence of an increase in arterial stiffness, it is unlikely that it would improve in conjunction with an increase in stiffness. Thus, this study will be the first to measure all of these variables to determine if and how they are influenced by training load.
The intestinal human microbiome is a recent target of interest due to its role in metabolic disease risk. Current evidence reports a link between cardiometabolic diseases and changes in the intestinal microbiota. The effects of exercise training on changes in the intestinal microbiome is also currently under investigation. Evidence in rat models currently suggest that voluntary and controlled aerobic exercise training is associated with favorable changes in the gut microbiome. However, human studies on the effects of exercise on the intestinal microbiome are currently lacking. .
The purpose of this study is to investigate the effects and potential differences between high load and low load RT on arterial stiffness. Based on the above described gaps in the literature the current study will serve as a follow up RCT to previous studies and will further explore the link between RT, arterial stiffness, and insulin sensitivity. From an exploratory stand-point we will examine changes if any in the gut microbiome following resistance training versus control. The proposed study will serve as a follow up RCT to investigate the differences between high load and low load RT on markers of arterial stiffness and insulin sensitivity. This study will also serve as the first RCT to investigate the long-term effects of RT in the intestinal microbiome. Studies investigating the effects of high load/low repetition RT on cardiometabolic biomarkers are currently lacking, with the current body of literature focusing on the effects of moderate and low loads and high repetitions, with limited data on the effects of high load RT.
- Conditions
- Insulin Sensitivity, Endothelial Dysfunction, Blood Pressure
- Being tested
- High Load/Low Rep Resistance Training, Low Load/High Rep Resistance Training
- Keywords
- insulin sensitivity, muscle, strength, resistance training, strength training, vascular function, arterial stiffness, glucose tolerance
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Load/Low Rep Resistance TrainingOther
Participants will be prescribed High Load/Low Rep resistance training.
Low Load/High Rep Resistance TrainingOther
Participants will be prescribed Low Load/High Rep resistance training.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training 1 | Experimental | Participants will perform resistance training with high training loads and low repetitions (high load/low rep resistance training). Receives: Other: High Load/Low Rep Resistance Training |
| Resistance Training 2 | Experimental | Participants will perform resistance training with low training loads and high repetitions (Low load/high rep resistance training). Receives: Other: Low Load/High Rep Resistance Training |
| Wait-list control | No intervention | This group will be offered the option of participating in either experimental group after the study is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Stiffness
Measured via pulse wave velocity
Measured: Change from Baseline Pulse Wave Velocity at 12 weeks
Secondary outcomes (11)
Insulin Sensitivity
Measured via oral glucose tolerance testing (OGTT)
Measured: Change from Baseline Matsuda Index at 12 weeks
Endothelial Function
Measured via flow mediated dilation (FMD)
Measured: Change from Baseline %FMD at 12 weeks
Cardiac echocardiography
Measured using ultrasound
Measured: Changes in systolic and diastolic parameters from baseline to 12 weeks
Isokinetic Strength
Measured via dynamometry
Measured: Change from Baseline isokinetic strength at 12 weeks
Isometric Strength
Measured via dynamometry
Measured: Change from Baseline Isometric strength at 12 weeks
Hexokinase
Measured via skeletal muscle biopsies
Measured: Change from Baseline in insulin signalling proteins at 12 weeks
Insulin signaling proteins
Measured via skeletal muscle biopsies
Measured: Change from Baseline in insulin signaling proteins at 12 weeks
Muscle Volume
Measured via ultrasonography
Measured: Change from Baseline Muscle Volume at 12 weeks
Body Composition
Measured via Dual X-Ray Absorptiometry (DXA)
Measured: Change from Baseline body composition at 12 weeks
Central Systolic Pressure
Measured via Pulse Wave Analysis
Measured: Change from Baseline Central Systolic Pressure at 12 weeks
Central Diastolic Pressure
Measured via Pulse Wave Analysis
Measured: Change from Baseline Central Systolic Pressure at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start21 Sep 2017
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siddhartha Angadi, Arizona State University
- Investigators
- Siddhartha S Angadi, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325933
- Sponsor's protocol ID
- STUDY00006617
- Status last verified
- Apr 2021
- First submitted
- 13 Oct 2017
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This data will be used primarily for a doctoral dissertation project as well as manuscript publication.
Publications
Yang Q, Cogswell ME, Flanders WD, Hong Y, Zhang Z, Loustalot F, Gillespie C, Merritt R, Hu FB. Trends in cardiovascular health metrics and associations with all-cause and CVD mortality among US adults. JAMA. 2012 Mar 28;307(12):1273-83. doi: 10.1001/jama.2012.339. Epub 2012 Mar 16.
PubMed 22427615Safar ME, Czernichow S, Blacher J. Obesity, arterial stiffness, and cardiovascular risk. J Am Soc Nephrol. 2006 Apr;17(4 Suppl 2):S109-11. doi: 10.1681/ASN.2005121321.
PubMed 16565231Wildman RP, Mackey RH, Bostom A, Thompson T, Sutton-Tyrrell K. Measures of obesity are associated with vascular stiffness in young and older adults. Hypertension. 2003 Oct;42(4):468-73. doi: 10.1161/01.HYP.0000090360.78539.CD. Epub 2003 Sep 2.
PubMed 12953016Strasser B, Arvandi M, Pasha EP, Haley AP, Stanforth P, Tanaka H. Abdominal obesity is associated with arterial stiffness in middle-aged adults. Nutr Metab Cardiovasc Dis. 2015 May;25(5):495-502. doi: 10.1016/j.numecd.2015.01.002. Epub 2015 Jan 28.
PubMed 25770757Mitchell GF, Hwang SJ, Vasan RS, Larson MG, Pencina MJ, Hamburg NM, Vita JA, Levy D, Benjamin EJ. Arterial stiffness and cardiovascular events: the Framingham Heart Study. Circulation. 2010 Feb 2;121(4):505-11. doi: 10.1161/CIRCULATIONAHA.109.886655. Epub 2010 Jan 18.
PubMed 20083680Vlachopoulos C, Aznaouridis K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with arterial stiffness: a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Mar 30;55(13):1318-27. doi: 10.1016/j.jacc.2009.10.061.
PubMed 20338492Ashor AW, Lara J, Siervo M, Celis-Morales C, Mathers JC. Effects of exercise modalities on arterial stiffness and wave reflection: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2014 Oct 15;9(10):e110034. doi: 10.1371/journal.pone.0110034. eCollection 2014.
PubMed 25333969Hellsten Y, Nyberg M. Cardiovascular Adaptations to Exercise Training. Compr Physiol. 2015 Dec 15;6(1):1-32. doi: 10.1002/cphy.c140080.
PubMed 26756625Miyachi M. Effects of resistance training on arterial stiffness: a meta-analysis. Br J Sports Med. 2013 Apr;47(6):393-6. doi: 10.1136/bjsports-2012-090488. Epub 2012 Jan 20.
PubMed 22267567Bertovic DA, Waddell TK, Gatzka CD, Cameron JD, Dart AM, Kingwell BA. Muscular strength training is associated with low arterial compliance and high pulse pressure. Hypertension. 1999 Jun;33(6):1385-91. doi: 10.1161/01.hyp.33.6.1385.
PubMed 10373221Miyachi M, Donato AJ, Yamamoto K, Takahashi K, Gates PE, Moreau KL, Tanaka H. Greater age-related reductions in central arterial compliance in resistance-trained men. Hypertension. 2003 Jan;41(1):130-5. doi: 10.1161/01.hyp.0000047649.62181.88.
PubMed 12511542Fahs CA, Heffernan KS, Ranadive S, Jae SY, Fernhall B. Muscular strength is inversely associated with aortic stiffness in young men. Med Sci Sports Exerc. 2010 Sep;42(9):1619-24. doi: 10.1249/MSS.0b013e3181d8d834.
PubMed 20195176Miyachi M, Kawano H, Sugawara J, Takahashi K, Hayashi K, Yamazaki K, Tabata I, Tanaka H. Unfavorable effects of resistance training on central arterial compliance: a randomized intervention study. Circulation. 2004 Nov 2;110(18):2858-63. doi: 10.1161/01.CIR.0000146380.08401.99. Epub 2004 Oct 18.
PubMed 15492301Rakobowchuk M, McGowan CL, de Groot PC, Bruinsma D, Hartman JW, Phillips SM, MacDonald MJ. Effect of whole body resistance training on arterial compliance in young men. Exp Physiol. 2005 Jul;90(4):645-51. doi: 10.1113/expphysiol.2004.029504. Epub 2005 Apr 22.
PubMed 15849230Yoshizawa M, Maeda S, Miyaki A, Misono M, Saito Y, Tanabe K, Kuno S, Ajisaka R. Effect of 12 weeks of moderate-intensity resistance training on arterial stiffness: a randomised controlled trial in women aged 32-59 years. Br J Sports Med. 2009 Aug;43(8):615-8. doi: 10.1136/bjsm.2008.052126. Epub 2008 Oct 16.
PubMed 18927168
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training and Cardiometabolic Health
- ClinicalTrials.gov ID
- NCT03325933
- Acronym / sponsor ID
- STUDY00006617
- Conditions
- Insulin Sensitivity, Endothelial Dysfunction, Blood Pressure
- Keywords
- insulin sensitivity, muscle, strength, resistance training, strength training, vascular function, arterial stiffness, glucose tolerance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 30 Oct 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.
This study will investigate the relationship between resistance training load and repetitions on cardiometabolic outcomes. The primary objective of this clinical trial is to determine whether high load or low load resistance exercise training affects arterial stiffness in overweight or obese men and women. Our secondary objectives are to investigate the effects of high and low load RT on vascular function, cardiac structure, and markers of insulin sensitivity. Finally, we are going to preliminarily explore the effects of resistance training on intestinal bacteria.
Detailed description
While it has been firmly established that aerobic exercise training is an effective modality for managing cardiometabolic disease risk, the influence of resistance training (RT) is not as well characterized. It is well established that RT improves muscular strength, size, cross sectional area, and bone mineral density. Alterations in muscle fiber type, glycolytic and oxidative enzyme profile, skeletal muscle proteins, and rates of protein synthesis also occur in response to RT and are obtained from skeletal muscle biopsies. Data from quasi-experimental studies suggest that moderate-to-high repetition RT with lower training loads may positively affect skeletal muscle proteins (Glucose Transporter Type 4 (GLUT4), Hexokinase 2 (HK2), and Adenylate kinase 2 (AK2) involved in insulin signaling in non-diabetic, obese men. However, data on high load, low rep RT on these variables is lacking. Thus, we will collect skeletal muscle biopsies to determine if changes in insulin signaling skeletal muscle proteins are present in response to both training with both high and low training loads. There is also a body of evidence suggesting that RT may improve VO2peak values in individuals with low baseline VO2peak values via a possible increase in capillary density, however, results are currently mixed. Low VO2peak values in overweight and obese individuals are positively associated with high risk of cardiovascular and all-cause mortality. Thus, we will measure VO2peak values to determine if (A) starting previously untrained obese individuals with RT can also improve VO2peak and (B) potential changes in VO2peak are load dependent. RT has also been reported to improve insulin sensitivity and central pressure. Additionally, aerobic exercise training may positively influence alterations in the intestinal microbiome, with no currently available evidence on the effects of RT, Although RT has been shown to be beneficial for improving arterial stiffness and insulin sensitivity, most of the available literature is based on protocols prescribing moderate-to-high repetitions and thus lower training loads. Thus, the effects of prescribing higher training loads on the aforementioned variables are not fully understood.
Increased arterial stiffness (as characterized by carotid-femoral pulse wave velocity (PWV) and augmentation index) is a clinical marker for cardiovascular disease and an independent risk factor for adverse cardiovascular events and all-cause mortality. Increased arterial stiffness has is positively associated with insulin resistance and type II diabetes. In the early stages of insulin resistance, peripheral insulin action, which occurs primarily in the skeletal muscle is impaired. This leads to a compensatory increase in insulin release in order to maintain glucose homeostasis, thus leading to hypertrophy of the pancreatic β cells. During the early stages of insulin resistance, fasting glucose levels will remain normal, with hyperglycemia manifesting in the later stages. Chronic hyperinsulinemia and hyperglycemia in turn cause increases in the renin-angiotensin aldosterone system as well expression of the angiotensin type I receptor in vascular tissue, thus stimulating VSMC proliferation, which leads to an increase in arterial stiffness. Chronic hyperglycemia and/or type II diabetes can lead to an increase in the production of advanced glycation end products (AGEs), which are proteins or lipids that become glycated due to exposure to glucose. Excessive production of AGEs can lead to an increase in collagen cross linking in the vascular walls, which thus leads to an increase in arterial stiffness.
Thus, it appears that increases in arterial stiffness occur due to perturbations in pulsatile shear and flow, which leads to abnormal turnover of scaffolding proteins, specifically excessive collagen production, and the proliferation of VSMCs, which results in a stiffer vasculature. This is exacerbated by the insulin resistant and/or hyperglycemic state due to an increase in local activity of the RAAS and expression of angiotensin I receptor activation in the vascular wall and an increase in age production, which leads to an increase in VSMCs and collagen cross-linking, respectively, thus further contributing to the development of a stiffer vasculature. These structural changes can have deleterious downstream consequences that include ischemic heart disease, myocardial infarction, and heart failure.
Current studies on the effects of RT on arterial stiffness have reported mixed results. It has been suggested that training with higher loads may cause greater increases in stiffness than training with lower loads due to greater acute elevations in blood pressure that occur with high load RT. Case control studies have reported that resistance trained young and middle aged non obese men demonstrated higher levels of arterial stiffness when compared to their aged-matched counterparts. Alternative cross-sectional studies reported that muscular strength was inversely related with arterial stiffness. Follow-up randomized control trials (RCT) investigated changes in arterial stiffness after several months of RT in non-obese, resistance training naïve adults. Improvements in central pressure, in the absence of changes in PWV, have been reported in non-diabetic obese adults after 12 weeks of RT but the study lacked an effective control group. Additionally, improvements in insulin sensitivity in non-diabetic obese males after 12 weeks of RT but was not a randomized controlled trial (RCT). Improvements in endothelial function has also been reported after six months of progressive RT that included both moderate and high training loads. This is significant because endothelial dysfunction is a downstream consequence of increased arterial stiffness, and thus an improvement in endothelial function, as measured by relative flow mediated dilation (%FMD), in response to RT is a reflects an improvement in vascular function, which is unlikely to occur in conjunction with an increase in vascular stiffness. To our knowledge, there are no current published RCTs on the effects of high load RT that have measured both arterial stiffness and endothelial function. This study will follow up on previous studies by comparing the effects of two distinct RT protocols (high load vs low load) on arterial stiffness as, measured by PWV and augmentation index, and endothelial function, as measured by %FMD, to a nonexercising control group.
A body of literature exists to suggest that morphological changes of the left ventricle take place in response to resistance training. Case control studies have reported that elite resistance trained athletes demonstrate evidence of left ventricular wall thickening. The increase in left ventricular wall thickness is referred to as concentric hypertrophy, which occurs in response to a chronic increase in afterload. This occurs in the presence of increased arterial stiffness, uncontrolled hypertension, and aortic stenosis, all of which can lead to heart failure (HF). RT induced concentric hypertrophy appears to be a physiological training adaptation, similar to the eccentric hypertrophy that takes place in response to aerobic training, and thus does not appear to be deleterious. Furthermore, current RCTs on the effects of RT on morphological changes of the LV suggest that this adaptation does not always occur or may occur in response to specific training volumes, frequencies, intensities, and/or over a longer training duration. Since the main outcome of this study is arterial stiffness, which is a precursor for concentric hypertrophy of the LV, we will also measure left ventricular wall thickness to see if A) morphological changes in the LV take place and B) if LV morphological changes are influenced by training load.
Thus, it appears that moderate training loads are shown to improve insulin sensitivity in obese individuals. This is significant because insulin resistance is a precursor to increases in arterial stiffness. However, the effects of training with higher loads on insulin sensitivity is a current gap in the literature. It has been previously proposed that high load RT may reduce arterial compliance and/or lead to concentric hypertrophy of the left ventricular walls. However, current evidence suggests that both moderate and high training loads improve endothelial function, without negatively affecting the left ventricular wall. Since endothelial dysfunction is a negative downstream consequence of an increase in arterial stiffness, it is unlikely that it would improve in conjunction with an increase in stiffness. Thus, this study will be the first to measure all of these variables to determine if and how they are influenced by training load.
The intestinal human microbiome is a recent target of interest due to its role in metabolic disease risk. Current evidence reports a link between cardiometabolic diseases and changes in the intestinal microbiota. The effects of exercise training on changes in the intestinal microbiome is also currently under investigation. Evidence in rat models currently suggest that voluntary and controlled aerobic exercise training is associated with favorable changes in the gut microbiome. However, human studies on the effects of exercise on the intestinal microbiome are currently lacking. .
The purpose of this study is to investigate the effects and potential differences between high load and low load RT on arterial stiffness. Based on the above described gaps in the literature the current study will serve as a follow up RCT to previous studies and will further explore the link between RT, arterial stiffness, and insulin sensitivity. From an exploratory stand-point we will examine changes if any in the gut microbiome following resistance training versus control. The proposed study will serve as a follow up RCT to investigate the differences between high load and low load RT on markers of arterial stiffness and insulin sensitivity. This study will also serve as the first RCT to investigate the long-term effects of RT in the intestinal microbiome. Studies investigating the effects of high load/low repetition RT on cardiometabolic biomarkers are currently lacking, with the current body of literature focusing on the effects of moderate and low loads and high repetitions, with limited data on the effects of high load RT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance Training 1 | Experimental | Other: High Load/Low Rep Resistance TrainingParticipants will perform resistance training with high training loads and low repetitions (high load/low rep resistance training). |
| Resistance Training 2 | Experimental | Other: Low Load/High Rep Resistance TrainingParticipants will perform resistance training with low training loads and high repetitions (Low load/high rep resistance training). |
| Wait-list control | No intervention | –This group will be offered the option of participating in either experimental group after the study is completed. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female
- 18-55 years of age
- BMI 25-40
- No recent history of starting a structured exercise program or diet in the last 3 months
Key exclusion criteria (7 listed)
- Current smoker and/or recreational drug user
- Answers "yes" to one or more questions on the Physical Activity Readiness Questionnaire
- Diagnosed diabetes, heart disease
- History of anabolic steroid use in the past six months
- Taking medications for treatment of diabetes, heart disease, and hypertension.
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 |
|---|---|---|
| High Load/Low Rep Resistance TrainingParticipants will be prescribed High Load/Low Rep resistance training. | Other | Resistance Training 1 |
| Low Load/High Rep Resistance TrainingParticipants will be prescribed Low Load/High Rep resistance training. | Other | Resistance Training 2 |
Primary outcome
Arterial Stiffness
Time frame: Change from Baseline Pulse Wave Velocity at 12 weeks
Measured via pulse wave velocity
11 secondary outcomes
Insulin Sensitivity
Time frame: Change from Baseline Matsuda Index at 12 weeks
Endothelial Function
Time frame: Change from Baseline %FMD at 12 weeks
Cardiac echocardiography
Time frame: Changes in systolic and diastolic parameters from baseline to 12 weeks
Isokinetic Strength
Time frame: Change from Baseline isokinetic strength at 12 weeks
Isometric Strength
Time frame: Change from Baseline Isometric strength at 12 weeks
Hexokinase
Time frame: Change from Baseline in insulin signalling proteins at 12 weeks
Insulin signaling proteins
Time frame: Change from Baseline in insulin signaling proteins at 12 weeks
Muscle Volume
Time frame: Change from Baseline Muscle Volume at 12 weeks
Body Composition
Time frame: Change from Baseline body composition at 12 weeks
Central Systolic Pressure
Time frame: Change from Baseline Central Systolic Pressure at 12 weeks
Central Diastolic Pressure
Time frame: Change from Baseline Central Systolic Pressure at 12 weeks
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Background: PubMed 22427615Yang Q, Cogswell ME, Flanders WD, Hong Y, Zhang Z, Loustalot F, Gillespie C, Merritt R, Hu FB. Trends in cardiovascular health metrics and associations with all-cause and CVD mortality among US adults. JAMA. 2012 Mar 28;307(12):1273-83. doi: 10.1001/jama.2012.339. Epub 2012 Mar 16.
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- Individual participant dataSharing planned: No. This data will be used primarily for a doctoral dissertation project as well as manuscript publication.
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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.
Siddhartha S Angadi, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Load/Low Rep Resistance Training and Low Load/High Rep Resistance Training in people with Insulin Sensitivity and Endothelial Dysfunction, run by Arizona State University 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 7 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: stopped early, as of the sponsor's last update on 19 Apr 2021. 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 was stopped early (reason given: COVID-19). Results are not available in the source record.
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?
Arterial Stiffness (time frame: Change from Baseline Pulse Wave Velocity at 12 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 NCT03325933, which also lists 43 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 19 Apr 2021.