Improving Metabolic Health in Patients With Diastolic Dysfunction

NCT03448185 | Completed Results

• 1 other identifier: STU 062014-067
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 to reduction in visceral adiposity, regression of myocardial triglyceride levels and improvements in cardiac diastolic and vascular function.

Conditions

Obesity; Heart Failure, Diastolic; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1 year

Secondary Outcomes (3)

• Change From Baseline at 1 Year in Peak Volume of Oxygen (VO2)

  Baseline,1 year

• Change From Baseline at 1 Year in Markers of Arterial Stiffness

  Baseline, 1 year

• Change From Baseline at 1 Year in Left Ventricular Mass

  Baseline, 1 year

Study Arms (4)

Control

PLACEBO COMPARATOR

Subjects randomized to control group will receive olive oil placebo capsules and yoga intervention for 1 year.

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.

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.

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.

Behavioral: High intensity exercise; Dietary Supplement: olive oil capsules

Interventions

High intensity exercise BEHAVIORAL

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.

Exercise and omega-3 fatty acids; Exercise control

Omega-3 fish oil DIETARY_SUPPLEMENT

Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year.

Exercise and omega-3 fatty acids; Yoga and omega-3 fatty acids

Yoga BEHAVIORAL

Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise.

Control; Yoga and omega-3 fatty acids

olive oil capsules DIETARY_SUPPLEMENT

Subjects randomized to receive olive oil placebo will take 1 gram total of olive oil capsule per day.

Control; Exercise control

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

The Institute for Exercise and Environmental Medicine

Dallas, Texas, 75231, United States

Location

Related Publications (1)

• 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.

  PMID: 35361442 DERIVED

MeSH Terms

Conditions

Obesity; Heart Failure, Diastolic; Metabolic Syndrome

Interventions

High-Intensity Interval Training; Fish Oils; Yoga; Olive Oil

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Failure; Heart Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Oils; Lipids; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Eriko Iwatate
• Organization: University of Texas Southwestern Medical Center

Eriko.Iwatate@UTSouthwestern.edu

214-648-3680

Study Officials

• Benjamin D Levine, MD

  University of Texas Southwestern Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects and investigative team (except for statistician) are blinded to omega-3 vs olive oil placebo. Subjects and investigators are aware of exercise modality. Outcomes assessors are blinded to all aspects of subject randomization.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR

Model Details: 2x2 factorial design. Subjects are randomized to aerobic exercise or yoga as well as high dose omega-3 fatty acids or olive oil placebo.

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: February 27, 2018
• Study Start: June 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: January 5, 2023
• Results First Posted: January 5, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)