Recruiting

Observational Study

Sponsor:

Pennington Biomedical Research Center

Code:

NCT04583514

Conditions

Overweight and Obesity

Metabolic Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 42

Healthy Volunteers: Accepted

Interventions

Control

Overfeeding

Study Details

Brief summary:

Adipose, or fat, tissue is a plastic organ that retains the ability to expand and store excess calories during positive energy balance in humans. The capacity of subcutaneous (subQ) adipose tissue to expand and remodel is an important determinant of obesity-related health complications, and impaired expansion of subQ fat tissue is thought to contribute to the risk of diseases such as the Metabolic Syndrome (MetS) and type 2 diabetes mellitus (T2D). The objectives of the study are to evaluate the changes and mechanisms of (subQ) adipose tissue expandability that occur as a result of short-term weight gain and to investigate the effects on cardio-metabolic health outcomes. Findings from this study will provide new insight into the dynamics of adipose expansion and remodeling during changes in energy balance and how this may impact future fat tissue function and metabolic health.

Conditions

Overweight and Obesity

Metabolic Syndrome

Study ID

NCT04583514

Start date

Sep 15, 2020

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 42

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Men and pre-menopausal women
  • 18-42 years of age
  • BMI 23-35 kg/m2 (± 0.5 will be accepted)
  • Are willing to drink deuterium-labeled water (2H2O) for 8 weeks
  • Are willing to be randomized to either a CTL or 30% OF group
  • For women, if not using pharmaceutical (hormonal) contraception (i.e. birth control pills, vaginal ring, injections, or implant), must agree to use either a double barrier method as a form of birth control to prevent pregnancy (i.e. male condom with spermicide, with or without cervical cap or diaphragm); use implants or intrauterine contraceptive devices; have a tubal ligation (surgically sterile); practice abstinence; or be in an established relationship with a vasectomized or same sex partner during the entire duration of the study
  • Must be willing to adhere to all study procedures, including attendance at all study visits
  • If enrolled, agree to maintain the same level of physical activity throughout the duration of the study
  • Must be willing to have blood stored for future research

Exclusion Criteria:

  • Unstable weight in the last 3 months (± \~5% weight change)
  • Diagnosis of Type 1 or 2 diabetes or a fasting blood glucose > 110 mg/dL
  • Average screening blood pressure > 140/90 mmHg
  • Diagnosis of major organ disease (e.g. heart, kidney, lung, thyroid, liver disease) or abnormal liver enzymes that are, in the opinion of the MI, clinically significant and represent a problem for study inclusion.
  • Self-reported positive test for human immunodeficiency virus, hepatitis B or hepatitis C
  • Any current or previous eating disorders
  • Chronic use of systemic glucocorticoids (steroids), systemic adrenergic-stimulating agents, beta-blockers, antipsychotic medications, thiazolidinediones and other medications that may cause clinically significant weight gain or loss)
  • Chronic use of prescription weight loss medications or over the counter weight loss medications which, in the opinion of the MI, will impact the study
  • Chronic use of anti-depressant medications for less than 3 months
  • Chronic smokers or users of tobacco products who cannot abstain for the duration of the inpatient visits
  • Previous bariatric or other surgeries for obesity
  • Had cancer in the last 5 years (some skin cancers acceptable)
  • Pregnancy, breastfeeding, or planned pregnancy for the upcoming 6 months
  • Partial or full hysterectomy
  • PCOS
  • Diagnosed psychotic conditions.

Study Design

Enrollment

58 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Control

The control group will be expected to maintain their weight within 1 kg of baseline weight throughout the duration of the study.

experimental: Overfeeding

The overfeeding group will be subjected to a similar relative change in energy intake, in which their dietary intake will be 30% more kcal/d than needed for weight maintenance.

Interventions

Control

Weight-stable Control group

Overfeeding

30% Overfeeding group

Primary outcome measure

  • Adipose tissue expansion and remodeling -- in vivo adipocyte formation [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Ursula White, Ph.D.

225-763-2656ursula.white@pbrc.edu

Locations

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70809

Contacts

Ursula White, Ph.D.

225-763-2656ursula.white@pbrc.edu

More Information

Sponsor

Pennington Biomedical Research Center

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • Overweight
  • Adipose tissue
  • Subcutaneous abdominal
  • Subcutaneous femoral
  • Adipocyte
  • Adipose turnover
  • Adipose kinetics
  • Adipogenesis
  • Ectopic fat
  • Insulin sensitivity
  • Deuterium

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Pennington Biomedical Research Center on 2026-04-08.