NCT04093440

Brief Summary

Intensive lifestyle intervention has shown to be effective in high risk patient populations and has gathered support from leaders-as outlined in the 2015 consensus paper by the Cardiometabolic Health Alliance. Thus there has been a call to establish new care models that assist Metabolic Syndrome patients in reducing there risk. The investigators aim to evaluate the impact of a lifestyle intervention program on metabolic syndrome patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

September 5, 2019

Last Update Submit

September 16, 2019

Conditions

Metabolic SyndromeASCVDLifestyle Risk Reduction

Keywords

cardiometabolic clinic

Outcome Measures

Primary Outcomes (1)

  • Reversal of metabolic syndrome

    Change in number of metabolic syndrome risk factors

    At the end of 12 months

Secondary Outcomes (5)

  • Mortality

    within three to five years of intervention

  • hemoglobin A1c

    At the end of 12 months

  • waist circumference

    At the end of 12 months

  • blood pressure

    At the end of 12 months

  • total cholesterol

    At the end of 12 months

Study Arms (1)

Observation

OTHER

lifestyle modification: nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization

Other: lifestyle modification

Interventions

lifestyle modificationOTHER

nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization

Observation

Eligibility Criteria

Age18 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metabolic syndrome patients meeting 3 of 5 criteria:
  • waist circumference (37 in) in white and AA men, (35 in) in Asian men, and (31.5 in) in women;
  • triglycerides ≥150 mg/dl;
  • high-density lipoprotein cholesterol (HDL-C) \<40 mg/dl in men and \<50 mg/dl in women;
  • blood pressure ≥130/85 mm Hg
  • fasting glucose ≥100 mg/d or HgbA1c ≥ 5.71 (includes diabetics)
  • Patients requiring secondary ASCD prevention

You may not qualify if:

  • Patients with less than 5 year survival
  • Patients with cancer undergoing therapy or on palliative treatment
  • Patients with end stage heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internal Medicine Residency Clinic at Holy Cross Hospital

Fort Lauderdale, Florida, 33334, United States

Location

MeSH Terms

Conditions

Metabolic SyndromeRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Study Officials

  • Charles Russo, MD

    Jim Moran Heart and Vascular Research Center at Holy Cross Hospital

    PRINCIPAL INVESTIGATOR

  • Paul Papagni, JD

    Jim Moran Heart and Vascular Research Center at Holy Cross Hospital

    STUDY DIRECTOR

Central Study Contacts

Charles Russo, MD

CONTACT

9547718000chuckiedrusso@aol.com

Abdullah Sarkar, MD

CONTACT

4698183688axs2500@miami.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 18, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2020

Study Completion

December 1, 2021

Last Updated

September 18, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)