Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding

NCT04583514 | Recruiting DMC

• 2 other identifiers: PBRC 2019-051R01DK121944
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Adipose tissue expansion and remodeling -- in vivo adipocyte formation

  Following the consumption of deuterium-labeled water (2H2O; heavy water), adipose tissue biopsies from the subcutaneous abdominal and femoral depots will be collected. The 2H from the heavy water is enriched into the DNA of newly synthesized cells. The primary outcome is to assess changes in new adipocyte formation in vivo and other mechanisms of adipose expansion and remodeling in response to 30% overfeeding (OF group) relative to the weight-stable CTL group.

  8 weeks

Secondary Outcomes (2)

• Adipose tissue expansion and remodeling -- in vivo triglyceride synthesis

  8 weeks

• Cardiometabolic health outcomes

  8 weeks

Study Arms (2)

Control

EXPERIMENTAL

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

Behavioral: Control

Overfeeding

EXPERIMENTAL

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.

Behavioral: Overfeeding

Interventions

Control BEHAVIORAL

Weight-stable Control group

Control

Overfeeding BEHAVIORAL

30% Overfeeding group

Overfeeding

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and pre-menopausal women
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70809, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Ursula White, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ursula White, Ph.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 12, 2020
• Study Start: September 15, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)