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The Effect of Structured Lifestyle Modification and Yoga Practice on Metabolic Processes Associated With Cardiovascular Disease (SLYM II)

Primary Purpose

Coronary Artery Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Chair Yoga

About this trial

This is an interventional basic science trial for Coronary Artery Disease focused on measuring Coronary artery disease, metabolic abnormality, chair yoga, micro RNA

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Subjects eligible for the study are 18-80 year old adults.
Underwent percutaneous coronary intervention (PCI) at the catheterization lab of Mount Sinai Hospital (New York, New York) or have non-obstructive coronary artery disease and at least one CVD risk factor (hypertension, hypercholesterolemia, diabetes mellitus, or obesity) or metabolic abnormality (fasting plasma glucose ≥ 100 mg/dl, documented previous diagnosis of hypertension, serum triglycerides ≥ 150 mg/dl, or HDL cholesterol < 40 mg/dl).
Subjects diagnosed with metabolic syndrome, which is defined as three or more of the following conditions: (1) Central or abdominal obesity (waist circumference > 40 inches for men and > 35 inches for women); (2) High triglycerides (≥150 mg/dL or triglycerides treatment); (3) Low HDL cholesterol (<40 mg/dL for men and <50 mg/dL for women) or low HDL-C treatment; (4) High blood pressure (≥130/85 mmHg) or antihypertensive medications; (5) High fasting glucose (≥100 mg/dL) or type 2 diabetes mellitus.
Participants must be able to willingly consent to study participation and must be able to comply with the study requirements.

Exclusion Criteria:

Physical/psychological limitation or unwillingness to practice yoga,
Congestive heart failure, known arrthymias or prior Automated Implantable Cardioverter-Defibrillator /pacemaker or any metallic implants,
Rheumatological/immunological diseases,
History of transplant,
Moderate to severe chronic obstructive pulmonary disease, debilitating or severe systemic Illness,
Subjects who are pregnant or postpartum less than 6 months,
Liver disease or alcohol use of more than 7 alcoholic drinks/week in women and more than 14 drinks/week in men

Sites / Locations

Mount Sinai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Yoga

Standard of Care

Arm Description

Patients randomized to Yoga arm will practice chair yoga for 30 minutes at least three days a week for 16 weeks

Control group patients will follow standard of care (SOC) treatment.

Outcomes

Primary Outcome Measures

micro RNA expression

Secondary Outcome Measures

Body weight

Body weight, kg

Waist circumference

Waist circumference, inches

Blood pressure

blood pressure

Full Information

NCT ID

NCT05250310

First Posted

February 10, 2022

Last Updated

March 29, 2023

Sponsor

Icahn School of Medicine at Mount Sinai

1. Study Identification

Unique Protocol Identification Number

NCT05250310

Brief Title

The Effect of Structured Lifestyle Modification and Yoga Practice on Metabolic Processes Associated With Cardiovascular Disease

Acronym

SLYM II

Official Title

The Effect of Structured Lifestyle Modification and Yoga Practice on Metabolic Processes Associated With Cardiovascular Disease

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 24, 2022 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the prospective randomized single center study is to evaluate the effect of a short-term (16 weeks) yoga program on micro RNA (miRNA) expression and cardiovascular disease (CVD) risk factors in patients with CVD.

Detailed Description

Cardiovascular disease (CVD) and metabolic syndrome (MetS) are major public health problems in the USA and worldwide. Yoga has been proven effective in numerous studies to improve cardiovascular risk factors, with a reduction in the risk of heart attacks and strokes. MicroRNAs (miRNAs) have recently emerged as key regulators of metabolism by playing a crucial role in cholesterol and lipid metabolism, fatty acid metabolism, insulin and glucose homeostasis. Yoga has been shown to induce a dynamic shift in miRNAs and reset their target genes expression associated with metabolites and pathways connected to CVD and MetS to a normal physiological state. 120 subjects will be included in the study. After recruitment, subjects will be randomized to one of two groups: Yoga (n=60) or Control (n=60) group. Patients randomized to Yoga, will practice yoga poses in a chair for 30 min at least 3 days a week by watching video instruction for 16 weeks. Control group patients will follow standard of care (SOC) treatment. At the enrollment day and at the 16-weeks follow-up visit, 15ml of blood will be collected from all participants for miRNAs expression profile.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Coronary artery disease, metabolic abnormality, chair yoga, micro RNA

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Two group randomization 1:1

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Yoga

Arm Type

Active Comparator

Arm Description

Patients randomized to Yoga arm will practice chair yoga for 30 minutes at least three days a week for 16 weeks

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

Control group patients will follow standard of care (SOC) treatment.

Intervention Type

Behavioral

Intervention Name(s)

Chair Yoga

Intervention Description

Yoga poses performed in a chair

Primary Outcome Measure Information:

Title

micro RNA expression

Time Frame

End of study, at 22 months

Secondary Outcome Measure Information:

Title

Body weight

Description

Body weight, kg

Time Frame

End of study, at 22 months

Title

Waist circumference

Description

Waist circumference, inches

Time Frame

End of study, at 22 months

Title

Blood pressure

Description

blood pressure

Time Frame

End of study, at 22 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Subjects eligible for the study are 18-80 year old adults. Underwent percutaneous coronary intervention (PCI) at the catheterization lab of Mount Sinai Hospital (New York, New York) or have non-obstructive coronary artery disease and at least one CVD risk factor (hypertension, hypercholesterolemia, diabetes mellitus, or obesity) or metabolic abnormality (fasting plasma glucose ≥ 100 mg/dl, documented previous diagnosis of hypertension, serum triglycerides ≥ 150 mg/dl, or HDL cholesterol < 40 mg/dl). Subjects diagnosed with metabolic syndrome, which is defined as three or more of the following conditions: (1) Central or abdominal obesity (waist circumference > 40 inches for men and > 35 inches for women); (2) High triglycerides (≥150 mg/dL or triglycerides treatment); (3) Low HDL cholesterol (<40 mg/dL for men and <50 mg/dL for women) or low HDL-C treatment; (4) High blood pressure (≥130/85 mmHg) or antihypertensive medications; (5) High fasting glucose (≥100 mg/dL) or type 2 diabetes mellitus. Participants must be able to willingly consent to study participation and must be able to comply with the study requirements. Exclusion Criteria: Physical/psychological limitation or unwillingness to practice yoga, Congestive heart failure, known arrthymias or prior Automated Implantable Cardioverter-Defibrillator /pacemaker or any metallic implants, Rheumatological/immunological diseases, History of transplant, Moderate to severe chronic obstructive pulmonary disease, debilitating or severe systemic Illness, Subjects who are pregnant or postpartum less than 6 months, Liver disease or alcohol use of more than 7 alcoholic drinks/week in women and more than 14 drinks/week in men

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yuliya Vengrenyuk

Phone

212-241-0460

yuliya.vengrenyuk@mountsinai.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annapoorna Kini, MD

Organizational Affiliation

MOUNT SINAI HOSPITAL

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuliya Vengrenyuk, PhD

yuliya.vengrenyuk@mountsinai.org

First Name & Middle Initial & Last Name & Degree

Annapoorna Kini

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Effect of Structured Lifestyle Modification and Yoga Practice on Metabolic Processes Associated With Cardiovascular Disease

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