ObesityMTGNCT03448185
Improving Metabolic Health in Patients With Diastolic Dysfunction
A study testing High intensity exercise, Omega-3 fish oil and Yoga in people with Obesity and Heart Failure, Diastolic, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether 1 year of supervised exercise training in obese individuals at high risk for developing HF, incorporating high intensity interval training (HIIT) two to three times per week in conjunction with daily oral administration of omega-3 poly-unsaturated fatty acids will lead… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Heart Failure, Diastolic, Metabolic Syndrome
- What is being tested?
- High intensity exercise, Omega-3 fish oil and Yoga
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ejection fraction >0.50
- >2.0 kg visceral fat (intra- and retro-peritoneal adipose tissue)
- either a high sensitivity troponin (>0.6pg/ml), or NTBNP (>40 ng/ml)
- age range 40 -60
- BMI range 30 - 50 kg/m2
Who cannot join
- age < 40 or > 60
- body mass index > 50, < 30 kg/m2
- history of insulin dependent diabetes, heart failure, myocarditis, restrictive cardiomyopathy, permanent/persistent atrial fibrillation, severe chronic obstructive pulmonary disease, unstable coronary artery disease or recent (<12 month) acute coronary syndrome, cerebrovascular disease as evidenced by prior transient ischemic attack or stroke and active/recent tobacco use (quit < 5 years).
- Female patients will be excluded if they are pregnant or plan to become pregnant (expected rare occurrence in the selected age range of 40 - 60). 5. Patients will be excluded if they are taking non-statin lipid lowering agents (fibrates, niacin, or fish oils)
- Contra-indications to MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
The Institute for Exercise and Environmental Medicine
Dallas, Texas, 75231
About this study
Official title: Reduction of Cardiac Steatosis and Improvement of Diastolic Function by Modulating Metabolic Health in Obese Individuals
The purpose of this study is to determine whether 1 year of supervised exercise training in obese individuals at high risk for developing HF, incorporating high intensity interval training (HIIT) two to three times per week in conjunction with daily oral administration of omega-3 poly-unsaturated fatty acids will lead to reduction in visceral adiposity, regression of myocardial triglyceride levels and improvements in cardiac diastolic and vascular function.
Read the detailed description
The global objective of this project is to test novel strategies to prevent obesity related abnormalities in diastolic function that may progress to heart failure with preserved ejection fraction (HFpEF). These include: a) identifying high risk individuals by using population derived imaging and blood biomarkers; and b) implementing novel exercise training and "nutri-ceutical" strategies in obese middle aged individuals with high amounts of visceral fat, an important risk factor in the development of heart failure and adverse cardiac remodeling.
Prior work has demonstrated that: a) high levels of myocardial triglyceride content are associated with a smaller and less distensible left ventricle with reduced tissue relaxation rates compared to those with low levels and b) low fitness and high body mass index were the strongest predictors of elevated myocardial content. The consequences of excess visceral adiposity (intra- and retro-peritoneal adipose tissue) on cardiac remodeling suggest individuals with high visceral fat content and low fitness are at particularly high risk for heart failure.
The primary objective of this project is therefore to identify high risk, sedentary, middle aged obese individuals with high visceral fat levels, and initiate an exercise program in conjunction with omega-3 fatty acid supplementation designed to reduce visceral adiposity and regress myocardial triglyceride accumulation. Findings from this aim would have enormous public health significance and establish a novel, practical exercise training program and "nutria-ceutical" strategy to reverse obesity related cardiovascular remodeling.
Hypothesis:
High aerobic exercise training in conjunction with daily omega-3 supplementation will reduce visceral myocardial triglyceride accumulation by reducing visceral adiposity. A reduction of myocardial fat will lead to improved LV structure and diastolic function by an approach that is not necessarily predicated on weight loss.
Specific Aim:
To test our hypothesis that reduction in myocardial triglyceride content will improve markers of diastolic function, we have designed a randomized, double blind, placebo controlled trial. We will study four groups of previously sedentary obese middle aged subjects at high risk for development of HF for one year with the following interventions: A) sedentary controls taking placebo; B) sedentary subjects taking omega-3 fatty acids; C) subjects undergoing high intensity aerobic exercise training while on placebo and D) subjects undergoing high intensity aerobic exercise training while taking omega-3 fatty acids. Subjects will be categorized as high risk and enrolled on the basis of elevated serum biomarkers (cTnT) and high visceral fat content (>2.5 kg). We will perform comprehensive non-invasive assessments of cardiovascular structure and systolic/diastolic function before and after 1 year of an exercise intervention involving high intensity intervals and omega-3 administration. We anticipate the combination of high intensity aerobic exercise in conjunction with high dose omega-3 supplementation will reduce visceral adiposity, decrease myocardial triglyceride content and improve markers of diastolic and vascular function.
- Conditions
- Obesity, Heart Failure, Diastolic, Metabolic Syndrome
- Being tested
- High intensity exercise, Omega-3 fish oil, Yoga, olive oil capsules
- Medical subject headings
- Obesity, Heart Failure, Diastolic, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity exerciseBehavioural
Subjects will be randomized to the exercise groups will undergo 1 year aerobic exercise training comprised of high intensity exercise sessions 2-3 days per week. Sessions will be supervised remotely via heart rate monitors.
Omega-3 fish oilDietary supplement
Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year.
YogaBehavioural
Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise.
olive oil capsulesDietary supplement
Subjects randomized to receive olive oil placebo will take 1 gram total of olive oil capsule per day.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Subjects randomized to control group will receive olive oil placebo capsules and yoga intervention for 1 year. Receives: Behavioral: Yoga; Dietary Supplement: olive oil capsules |
| Exercise and omega-3 fatty acids | Experimental | Subjects will receive high dose omega-3 fatty acids as well as aerobic exercise intervention for 1 year. Receives: Behavioral: High intensity exercise; Dietary Supplement: Omega-3 fish oil |
| Yoga and omega-3 fatty acids | Active comparator | Subjects will receive high dose omega-3 fatty acids as well as yoga intervention for 1 year. Receives: Dietary Supplement: Omega-3 fish oil; Behavioral: Yoga |
| Exercise control | Active comparator | Subjects will receive olive oil placebo as well as aerobic exercise intervention for 1 year. Receives: Behavioral: High intensity exercise; Dietary Supplement: olive oil capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline at 1 Year in Myocardial Lipid Content
Myocardial triglyceride (lipid) content will be measured using cardiac nuclear magnetic resonance spectroscopy.
We quantified the total myocardial triglyceride (TG) resonance from water-suppressed spectra. Myocardial TG content relative to water (%) as well as relative amounts of myocardial TG was calculated from the available data.
Measured: Baseline, 1 year
Secondary outcomes (3)
Change From Baseline at 1 Year in Peak Volume of Oxygen (VO2)
Change in peak VO2 (normalized for body weight those who completed the study). Peak VO2 is a measure how well the heart and lungs are working during exercise.
Measured: Baseline,1 year
Change From Baseline at 1 Year in Markers of Arterial Stiffness
Changes in arterial stiffness is measured using pulse-wave velocity (PWV) to look at intervention effects from baseline to 1 year in the control and treatment groups.
Measured: Baseline, 1 year
Change From Baseline at 1 Year in Left Ventricular Mass
Change in left ventricular mass is measured by cardiac MRI to look at intervention effects from baseline to 1 year in the control and treatment groups.
Measured: Baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Jun 2015
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial design. Subjects are randomized to aerobic exercise or yoga as well as high dose omega-3 fatty acids or olive oil placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satyam Sarma, University of Texas Southwestern Medical Center
- Investigators
- Benjamin D Levine, MD, Study director, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448185
- Sponsor's protocol ID
- STU 062014-067
- Acronym
- MTG
- Status last verified
- Apr 2022
- First submitted
- 21 Feb 2018
- Last updated
- 5 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hearon CM Jr, Dias KA, MacNamara JP, Hieda M, Mantha Y, Harada R, Samels M, Morris M, Szczepaniak LS, Levine BD, Sarma S. 1 Year HIIT and Omega-3 Fatty Acids to Improve Cardiometabolic Risk in Stage-A Heart Failure. JACC Heart Fail. 2022 Apr;10(4):238-249. doi: 10.1016/j.jchf.2022.01.004. Epub 2022 Mar 9.
PubMed 35361442
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Cardiac Steatosis and Improvement of Diastolic Function by Modulating Metabolic Health in Obese Individuals
- ClinicalTrials.gov ID
- NCT03448185
- Acronym / sponsor ID
- MTG / STU 062014-067
- Conditions
- Obesity, Heart Failure, Diastolic, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Posted 5 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether 1 year of supervised exercise training in obese individuals at high risk for developing HF, incorporating high intensity interval training (HIIT) two to three times per week in conjunction with daily oral administration of omega-3 poly-unsaturated fatty acids will lead to reduction in visceral adiposity, regression of myocardial triglyceride levels and improvements in cardiac diastolic and vascular function.
Detailed description
The global objective of this project is to test novel strategies to prevent obesity related abnormalities in diastolic function that may progress to heart failure with preserved ejection fraction (HFpEF). These include: a) identifying high risk individuals by using population derived imaging and blood biomarkers; and b) implementing novel exercise training and "nutri-ceutical" strategies in obese middle aged individuals with high amounts of visceral fat, an important risk factor in the development of heart failure and adverse cardiac remodeling.
Prior work has demonstrated that: a) high levels of myocardial triglyceride content are associated with a smaller and less distensible left ventricle with reduced tissue relaxation rates compared to those with low levels and b) low fitness and high body mass index were the strongest predictors of elevated myocardial content. The consequences of excess visceral adiposity (intra- and retro-peritoneal adipose tissue) on cardiac remodeling suggest individuals with high visceral fat content and low fitness are at particularly high risk for heart failure.
The primary objective of this project is therefore to identify high risk, sedentary, middle aged obese individuals with high visceral fat levels, and initiate an exercise program in conjunction with omega-3 fatty acid supplementation designed to reduce visceral adiposity and regress myocardial triglyceride accumulation. Findings from this aim would have enormous public health significance and establish a novel, practical exercise training program and "nutria-ceutical" strategy to reverse obesity related cardiovascular remodeling.
Hypothesis:
High aerobic exercise training in conjunction with daily omega-3 supplementation will reduce visceral myocardial triglyceride accumulation by reducing visceral adiposity. A reduction of myocardial fat will lead to improved LV structure and diastolic function by an approach that is not necessarily predicated on weight loss.
Specific Aim:
To test our hypothesis that reduction in myocardial triglyceride content will improve markers of diastolic function, we have designed a randomized, double blind, placebo controlled trial. We will study four groups of previously sedentary obese middle aged subjects at high risk for development of HF for one year with the following interventions: A) sedentary controls taking placebo; B) sedentary subjects taking omega-3 fatty acids; C) subjects undergoing high intensity aerobic exercise training while on placebo and D) subjects undergoing high intensity aerobic exercise training while taking omega-3 fatty acids. Subjects will be categorized as high risk and enrolled on the basis of elevated serum biomarkers (cTnT) and high visceral fat content (>2.5 kg). We will perform comprehensive non-invasive assessments of cardiovascular structure and systolic/diastolic function before and after 1 year of an exercise intervention involving high intensity intervals and omega-3 administration. We anticipate the combination of high intensity aerobic exercise in conjunction with high dose omega-3 supplementation will reduce visceral adiposity, decrease myocardial triglyceride content and improve markers of diastolic and vascular function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 factorial design. Subjects are randomized to aerobic exercise or yoga as well as high dose omega-3 fatty acids or olive oil placebo.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Yoga, Dietary Supplement: olive oil capsulesSubjects randomized to control group will receive olive oil placebo capsules and yoga intervention for 1 year. |
| Exercise and omega-3 fatty acids | Experimental | Behavioral: High intensity exercise, Dietary Supplement: Omega-3 fish oilSubjects will receive high dose omega-3 fatty acids as well as aerobic exercise intervention for 1 year. |
| Yoga and omega-3 fatty acids | Active comparator | Dietary Supplement: Omega-3 fish oil, Behavioral: YogaSubjects will receive high dose omega-3 fatty acids as well as yoga intervention for 1 year. |
| Exercise control | Active comparator | Behavioral: High intensity exercise, Dietary Supplement: olive oil capsulesSubjects will receive olive oil placebo as well as aerobic exercise intervention for 1 year. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ejection fraction >0.50
- >2.0 kg visceral fat (intra- and retro-peritoneal adipose tissue)
- either a high sensitivity troponin (>0.6pg/ml), or NTBNP (>40 ng/ml)
- age range 40 -60
- BMI range 30 - 50 kg/m2
Key exclusion criteria (5 listed)
- age < 40 or > 60
- body mass index > 50, < 30 kg/m2
- history of insulin dependent diabetes, heart failure, myocarditis, restrictive cardiomyopathy, permanent/persistent atrial fibrillation, severe chronic obstructive pulmonary disease, unstable coronary artery disease or recent (<12 month) acute coronary syndrome, cerebrovascular disease as evidenced by prior transient ischemic attack or stroke and active/recent tobacco use (quit < 5 years).
- Female patients will be excluded if they are pregnant or plan to become pregnant (expected rare occurrence in the selected age range of 40 - 60). 5. Patients will be excluded if they are taking non-statin lipid lowering agents (fibrates, niacin, or fish oils)
- Contra-indications to MRI
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 intensity exerciseSubjects will be randomized to the exercise groups will undergo 1 year aerobic exercise training comprised of high intensity exercise sessions 2-3 days per week. Sessions will be supervised remotely via heart rate monitors. | Behavioural | Exercise and omega-3 fatty acids, Exercise control |
| Omega-3 fish oilSubjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year. | Dietary supplement | Exercise and omega-3 fatty acids, Yoga and omega-3 fatty acids |
| YogaSubjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise. | Behavioural | Control, Yoga and omega-3 fatty acids |
| olive oil capsulesSubjects randomized to receive olive oil placebo will take 1 gram total of olive oil capsule per day. | Dietary supplement | Control, Exercise control |
Primary outcome
Change From Baseline at 1 Year in Myocardial Lipid Content
Time frame: Baseline, 1 year
Myocardial triglyceride (lipid) content will be measured using cardiac nuclear magnetic resonance spectroscopy. We quantified the total myocardial triglyceride (TG) resonance from water-suppressed spectra. Myocardial TG content relative to water (%) as well as relative amounts of myocardial TG was calculated from the available data.
3 secondary outcomes
Change From Baseline at 1 Year in Peak Volume of Oxygen (VO2)
Time frame: Baseline,1 year
Change From Baseline at 1 Year in Markers of Arterial Stiffness
Time frame: Baseline, 1 year
Change From Baseline at 1 Year in Left Ventricular Mass
Time frame: Baseline, 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35361442Hearon CM Jr, Dias KA, MacNamara JP, Hieda M, Mantha Y, Harada R, Samels M, Morris M, Szczepaniak LS, Levine BD, Sarma S. 1 Year HIIT and Omega-3 Fatty Acids to Improve Cardiometabolic Risk in Stage-A Heart Failure. JACC Heart Fail. 2022 Apr;10(4):238-249. doi: 10.1016/j.jchf.2022.01.004. Epub 2022 Mar 9.
- 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.
Benjamin D Levine, MD study director
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity exercise, Omega-3 fish oil and Yoga in people with Obesity and Heart Failure, Diastolic, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 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 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline at 1 Year in Myocardial Lipid Content (time frame: Baseline, 1 year). 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 NCT03448185, which also lists 1 linked publication.
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 5 Jan 2023.