Actively Recruiting

Phase Not Applicable
Age: 18Years - 42Years
All Genders
Healthy Volunteers
NCT04583514

Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding

Led by Pennington Biomedical Research Center · Updated on 2026-04-08

58

Participants Needed

1

Research Sites

328 weeks

Total Duration

On this page

Sponsors

P

Pennington Biomedical Research Center

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding

Who Can Participate

Age: 18Years - 42Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and pre-menopausal women
  • Aged 18 to 42 years
  • Body mass index (BMI) between 23 and 35 kg/m2 (plus or minus 0.5 accepted)
  • Willing to drink deuterium-labeled water for 8 weeks
  • Willing to be randomized to either the control or 30% overfeeding group
  • For women not using hormonal contraception, agree to use double barrier birth control or other approved contraceptive methods during the study
  • Willing to attend all study visits and follow all procedures
  • Agree to maintain the same physical activity level throughout the study
  • Willing to have blood stored for future research
Not Eligible

You will not qualify if you...

  • Unstable weight in the last 3 months (more than ±~5% change)
  • Diagnosis of type 1 or 2 diabetes or fasting blood glucose above 110 mg/dL
  • Average blood pressure above 140/90 mmHg
  • Major organ disease or abnormal liver enzymes considered clinically significant
  • Positive test for HIV, hepatitis B, or hepatitis C
  • Current or previous eating disorders
  • Chronic use of steroids, adrenergic agents, beta-blockers, antipsychotics, thiazolidinediones, or other medications affecting weight
  • Use of prescription or over-the-counter weight loss medications that may impact the study
  • Use of antidepressants for less than 3 months
  • Chronic smoking or tobacco use without ability to abstain during inpatient visits
  • Previous bariatric or obesity-related surgery
  • Cancer within the last 5 years (some skin cancers allowed)
  • Pregnancy, breastfeeding, or planned pregnancy within 6 months
  • Partial or full hysterectomy
  • Polycystic ovary syndrome (PCOS)
  • Diagnosed psychotic conditions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70809

Actively Recruiting

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Research Team

U

Ursula White, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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