Testing the Adipose Expandability Hypothesis in Vivo During Overfeeding

NCT ID: NCT04583514

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2025-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Control

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

Group Type: EXPERIMENTAL

Control

Intervention Type: BEHAVIORAL

Weight-stable Control group

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.

Group Type: EXPERIMENTAL

Overfeeding

Intervention Type: BEHAVIORAL

30% Overfeeding group

Interventions

Control

Weight-stable Control group

Intervention Type: BEHAVIORAL

Overfeeding

30% Overfeeding group

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Ursula White

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ursula White, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ursula White, Ph.D.

Role: CONTACT

ursula.white@pbrc.edu

225-763-2656

Facility Contacts

Ursula White, Ph.D.

Role: primary

ursula.white@pbrc.edu

225-763-2656

Other Identifiers

R01DK121944

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PBRC 2019-051

Identifier Type: -

Identifier Source: org_study_id