Beige Fat, Energy, and the Natriuretic Peptide System

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04357964
• Other study ID #: ENDA-025-17S-1
• Secondary ID: 1IK2CX001678
• Status: Active, not recruiting
• Start date: April 13, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 77
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
United States	Tennessee Valley Healthcare System Nashville Campus, Nashville, TN	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adipose tissue gene expression of UCP1 (Uncoupling Protein 1)- differences by obesity status	Primary endpoint is adipose tissue gene expression of UCP1 (Uncoupling Protein 1)- differences by obesity status.	Study Day 1
Secondary	Associations of adipose tissue gene expression of UCP1 with natriuretic peptide markers	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)	Study Day 1
Secondary	adipose tissue gene expression of UCP1 (Uncoupling Protein 1)- differences by race	The investigators will determine adipose tissue gene expression of UCP1 (Uncoupling Protein 1), and analyze differences by race (blacks compared with whites).	Study Day 1