Beige Fat, Energy, and the Natriuretic Peptide System

NCT04357964 | Completed Results

• 2 other identifiers: ENDA-025-17S-11IK2CX001678
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obesity

Keywords

adipose tissue; beige adipose tissue; cardiovascular physiology; B-type natriuretic peptide; metabolism; obesity

Outcome Measures

Primary Outcomes (1)

• 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 (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.

  Study Day 1

Secondary Outcomes (2)

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

  Study Day 1

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

  Study Day 1

Study Arms (1)

obese and lean individuals

obese and lean individuals

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers who are U.S. veterans

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Vanderbilt University Medical Center: collaborator

Study Sites (2)

VA TVHS Nashville

Nashville, Tennessee, 37212, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, and fat biopsy samples

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Alp Ikizler, Catherine McLaughlin Hakim Chair in Vascular Biology, Professor of Medicine
• Organization: Vanderbilt University Medical Center

alp.ikizler@vumc.org

(615) 343-7592

Study Officials

• Alp Ikizler, MD

  Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 22, 2020
• Study Start: April 13, 2020
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: August 1, 2024
• Results First Posted: August 1, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)