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Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding

ConditionsOverweight and ObesityMetabolic Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-42
SponsorPennington Biomedical Research Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Control

    Behavioral

    Weight-stable Control group

  • Overfeeding

    Behavioral

    30% Overfeeding group

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: ControlExperimental treatment 1 intervention
Group B: OverfeedingExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
8 weeks

Secondary outcomes

1

Adipose tissue expansion and remodeling -- in vivo triglyceride synthesis

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 incorporated into the glycerol component of the adipose, providing a measure of new triglyceride synthesis. A secondary outcome is to assess changes in triglyceride synthesis in vivo and other mechanisms of adipose expansion and remodeling in response to 30% overfeeding (OF group) relative to the weight-stable CTL group.

Time frame
8 weeks
2

Cardiometabolic health outcomes

A secondary outcome is to investigate the correlation between mechanisms of adipose tissue expansion and remodeling with changes in metabolic health outcomes (i.e. abdominal adiposity; insulin sensitivity; ectopic lipid) in response to 30% OF relative to the CTL group.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pennington Biomedical Research Center

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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