Beige Fat, Energy, and the Natriuretic Peptide System

NCT ID: NCT04357964

Last Updated: 2024-08-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-13

Study Completion Date

2022-10-31

Brief Summary

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Obese individuals experience an increased risk of cardiovascular and metabolic diseases. Evidence from genetic studies indicate that the natriuretic peptide (NP) system may protect against these diseases. NP levels differ by obesity status and race has not been established in humans. Thus, the investigators propose a study in which will quantify adipose tissue gene expression and energy expenditure in states of NP deficiency in humans. The overarching postulate is that obese and black individuals have NP deficiencies that contribute to less beige adipose tissue and lower energy expenditure.

Detailed Description

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Obesity represents a serious public health burden. Obese individuals experience increased risk of cardiovascular and metabolic cardiometabolic disease, including insulin diabetes, resistance, hypertension, and dyslipidemia. Obesity and obesity-associated cardiometabolic dysfunction are significant contributors to morbidity and mortality in Veterans. This indicates that obesity and cardiometabolic dysfunction are complex and multifactorial, and suggests that there are additional factors that contribute to the pathogenesis of obesity and its associated cardiometabolic risk that have been discovered. Moreover, some of the pharmacologic therapies for obesity can have adverse cardiovascular effects. Thus, it is crucial to improve the understanding of the multiple pathways contributing to the pathogenesis of obesity and obesity-associated cardiometabolic risk, including the identification of novel relevant pathways, in order to develop more effective treatments for these diseases. The proposed work will form a foundation for future high-impact studies of mechanisms for adiposity and cardiometabolic disease.

Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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obese and lean individuals

obese and lean individuals

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Men and women ages 18-55 years
* Body Mass Index (BMI) \>= 18.5 and \<25 kg/m2 (lean), or BMI 30 kg/m2 (obese)

Exclusion Criteria

* Significant pulmonary, liver, or renal disease
* Heart failure (any type) or unstable coronary artery disease
* Diabetes Mellitus (Types 1 and 2)
* Thyroid dysfunction
* Active malignancy
* Chronic inflammatory diseases, such as inflammatory bowel disease, hepatitis, rheumatoid arthritis
* Current use of medications likely to affect energy homeostasis, including glucocorticoids, amphetamines, and beta blockers
* Currently pregnant or breastfeeding, or unwilling to avoid becoming pregnant or breastfeeding during study duration
* Significant claustrophobia that would prevent the use of the metabolic cart as part of the study protocol
* Hemoglobin A1c (HbA1c) \>= 6.5%
* Liver Function Tests (LFTs) elevated \>3x upper limit of normal
* Estimated Glomerular Filtration Rate (eGFR) \<40 ml/min
* Currently abnormal thyroid stimulating hormone (TSH)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alp Ikizler, MD

Role: PRINCIPAL_INVESTIGATOR

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Locations

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VA TVHS Nashville

Nashville, Tennessee, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1IK2CX001678

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ENDA-025-17S-1

Identifier Type: -

Identifier Source: org_study_id

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