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Completed

NCT Number: NCT04357964

Beige Fat, Energy, and the Natriuretic Peptide System

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VA TVHS Nashville, Nashville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

  1. 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)

  2. 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).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Vanderbilt University Medical Center

Registry information

Official study title

Beige Fat, Energy, and the Natriuretic Peptide System (ENDA-025-17S)

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2020
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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