NCT06053645

Brief Summary

The purpose of this study is to evaluate the impact of a cardiometabolic clinic on percent body weight loss, body mass index (BMI), and visceral adiposity distribution in obese adults with cardiovascular disease (CVD) at 12 months.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

April 22, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

2.2 years

First QC Date

September 19, 2023

Last Update Submit

October 16, 2025

Conditions

Cardiovascular DiseasesObesity

Outcome Measures

Primary Outcomes (3)

  • Percent body weight loss

    Total percent body weight loss will be reported at 12 months based on the following formula: (Starting baseline weight minus current weight) / (starting baseline weight) x 100 equals % of body weight loss.

    12 months

  • Change in Body Mass Index (BMI)

    Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches x Height in inches)) x 703

    Baseline, 12 months

  • Change in visceral adiposity distribution

    Change in visceral adiposity distribution measured using dual energy X-ray absorptiometry (DEXA).

    Baseline, 12 months

Secondary Outcomes (17)

  • Change in Blood Pressure

    Baseline, 12 months

  • Change in point of care glucose

    Baseline, 12 months

  • Change in quality of diet

    Baseline, 12 months

  • Change in psychosocial distress as measured by Screening Tool for Psychological Distress (STOP-D)

    Baseline, 12 months

  • Change in psychosocial distress as measured by Impact of Event Scale-Revised (IES-R)

    Baseline, 12 months

  • +12 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to the cardiometabolic clinic at Mayo Clinic Hospital in Rochester, MN will be recruited for participation.

You may qualify if:

  • BMI ≥30 kg/m2
  • At least one of the following CVD: atrial fibrillation (AF), coronary artery disease (CAD), HFpEF (heart failure with preserved ejection fraction), HFrEF (heart failure with reduced ejection fraction), ACHD (adult congenital heart disease), or valvular heart disease
  • Patients evaluated in the Cardiometabolic clinic
  • Willingness to complete questionnaires/surveys
  • Ability to complete monthly self-assessments at home

You may not qualify if:

  • BMI \<30 kg/m2
  • Pregnancy or lactating women
  • Hemodynamically unstable CVD
  • Active malignancy
  • Autoimmune or systemic inflammatory diseases
  • Severe renal or hepatic failure
  • Being considered unsafe to participate as determined by the study physician
  • Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic medications, or other medications as determined by the study NP or physician
  • Patients with active psychosis, mania, or substance use disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kyla Lara-Breitinger, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Preventive/Vascular Research Team

CONTACT

(507) 538-7425RSTCVRUPREVENT@mayo.edu

Kyla Lara-Breitinger, M.D.

CONTACT

(507) 284-4441Lara.Kyla@mayo.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 26, 2023

Study Start

April 22, 2024

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)