Testing the Adipose Expandability Hypothesis in Vivo During Overfeeding
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Adipose tissue expansion and remodeling -- in vivo adipocyte formation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Diagnosed psychotic conditions.
研究组 & 干预措施
Control
The control group will be expected to maintain their weight within 1 kg of baseline weight throughout the duration of the study.
干预措施: Control (Behavioral)
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.
干预措施: Overfeeding (Behavioral)
结局指标
主要结局
Adipose tissue expansion and remodeling -- in vivo adipocyte formation
时间窗: 8 weeks
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.
次要结局
- Adipose tissue expansion and remodeling -- in vivo triglyceride synthesis(8 weeks)
- Cardiometabolic health outcomes(8 weeks)
研究者
Ursula White
Associate Professor
Pennington Biomedical Research Center