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Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding (EAT 2)

Primary Purpose

Overweight and Obesity, Metabolic Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Overfeeding
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight and Obesity focused on measuring Overweight, Adipose tissue, Subcutaneous abdominal, Subcutaneous femoral, Adipocyte, Adipose turnover, Adipose kinetics, Adipogenesis, Ectopic fat, Insulin sensitivity, Deuterium

Eligibility Criteria

18 Years - 42 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men and pre-menopausal women
  • 18-42 years of age
  • BMI 25-30 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 (± ~7 lbs)
  • 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
  • Smoking or use of tobacco products in the last 3 months
  • 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.

Sites / Locations

  • Pennington Biomedical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control

Overfeeding

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 5, 2020
Last Updated
December 12, 2022
Sponsor
Pennington Biomedical Research Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04583514
Brief Title
Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding
Acronym
EAT 2
Official Title
Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Metabolic Syndrome
Keywords
Overweight, Adipose tissue, Subcutaneous abdominal, Subcutaneous femoral, Adipocyte, Adipose turnover, Adipose kinetics, Adipogenesis, Ectopic fat, Insulin sensitivity, Deuterium

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
The control group will be expected to maintain their weight within 1 kg of baseline weight throughout the duration of the study.
Arm Title
Overfeeding
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Weight-stable Control group
Intervention Type
Behavioral
Intervention Name(s)
Overfeeding
Intervention Description
30% Overfeeding group
Primary Outcome Measure Information:
Title
Adipose tissue expansion and remodeling -- in vivo adipocyte formation
Description
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 Outcome Measure Information:
Title
Adipose tissue expansion and remodeling -- in vivo triglyceride synthesis
Description
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
Title
Cardiometabolic health outcomes
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and pre-menopausal women 18-42 years of age BMI 25-30 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 (± ~7 lbs) 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 Smoking or use of tobacco products in the last 3 months 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ursula White, Ph.D.
Phone
225-763-2656
Email
ursula.white@pbrc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula White, Ph.D.
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ursula White, Ph.D.
Phone
225-763-2656
Email
ursula.white@pbrc.edu

12. IPD Sharing Statement

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Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding

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