Current partner codePEPTIDESDE
NCT04357964·Not applicable·OBSERVATIONAL

Beige Fat, Energy, and the Natriuretic Peptide System

Status

Completed

Phase

Not applicable

Enrollment

137

Locations

2

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

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.

Interventions

Treatment arms and agents.

No intervention details reported.

Timeline

From registration to results.

  1. First posted

    Apr 22, 2020

  2. Study start

    Apr 13, 2020

  3. Primary completion

    Oct 31, 2022

  4. Study completion

    Oct 31, 2022

  5. Results posted

    Aug 1, 2024

  6. Registry updated

    Aug 1, 2024

Outcomes

What the study measures.

Primary outcomes

Adipose Tissue Gene Expression of UCP1 (Uncoupling Protein 1)- Differences by Obesity Status

Time frame · Study Day 1

Primary endpoint is adipose tissue gene expression of UCP1 (Uncoupling Protein 1)- differences by obesity status (obese vs. lean). Units for primary endpoint are relative UCP1 gene expression (quantified using quantitative real-time reverse-transcription polymerase chain reaction (qRT-PCR)), normalized to a housekeeping gene.

Secondary outcomes

Associations of Adipose Tissue Gene Expression of UCP1 (Uncoupling Protein 1) With Natriuretic Peptide Markers

Time frame · Study Day 1

The investigators will determine associations of adipose tissue gene expression of UCP1 with natriuretic peptide markers (natriuretic peptide receptor gene expression in adipose tissue, and circulating natriuretic peptide levels)

Adipose Tissue Gene Expression of UCP1 (Uncoupling Protein 1)- Differences by Race

Time frame · Study Day 1

The investigators will determine adipose tissue gene expression of UCP1 (Uncoupling Protein 1), and analyze differences by race (blacks compared with whites).

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
55 Years
Sex
ALL
Healthy volunteers
Yes

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)

Study locations

2 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

VA TVHS Nashville

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

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