Genetic and Environmental Contributions to Obesity Pathogenesis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Study 1: Hypothalamic Gliosis
研究概览
简要总结
The goal of this research is to investigate genetic and environmental factors that contribute to obesity through brain inflammation. The main questions are 1) if identical twins, who differ in food consumption habits, have differences in adiposity markers and brain inflammation and 2) if signs of brain inflammation in response to a specific diet is modified by genetics.
详细描述
In study 1, participant twin pairs that differ in habitual diet intake, will complete an in-person study visit that includes an MRI of the brain and abdomen, body composition measurement, a blood draw and questionnaires. In study 2, a different set of participant twin pairs will complete 3 in-person study visits over 2 weeks, during which all meals will be provided by the study. Visits will include brain MRI, body composition measurements, blood draws and questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-45 years
- •Differs in habitual diet from co-twin (study 1).
- •Willing to undergo 7-day overfeeding and hypocaloric feeding periods (study 2)
- •Member of the Washington State Twin Registry
排除标准
- •History of bariatric surgery or active participation in weight-loss program
- •Major medical or neurological disorder (e.g., diabetes, multiple sclerosis)
- •Known gallbladder disease, anemia, impaired thyroid, kidney or liver function or hypertriglyceridemia (>350 mg/dl) (study 2)
- •Current use of weight-loss medications or other medications known to alter appetite (e.g., atypical anti-psychotics)
- •High levels of vigorous physical activity (>300 min./week)
- •Pregnancy, menopause, or breastfeeding
- •Individuals with severe food allergies and dietary restrictions (e.g., vegan/vegetarian, gluten-free, others) (study 2)
- •Co-twin unwilling or unable to participate
- •MRI contraindication (e.g., implanted metal, claustrophobia)
- •Lifetime eating disorder
- •Current smoking or heavy alcohol use (≥ 2 drinks per day for females and ≥ 3 drinks per day for males)
- •BMI > 45 kg/m2 (study 1)
- •BMI > 35 kg/m2 (study 2)
- •Weight > 350 pounds or determined to be safe by MRI tech (MRI limit)
- •Inability to participate in a controlled diet program (study 2) or undergo other study procedures
- •Non-English speaking-or-reading individuals
研究组 & 干预措施
Study 1, A co-twin control study of habitual diet
Monozygotic twin pairs with differential habitual diet practices will undergo measurements including body composition, and MRI measures of hepatic adiposity and neuroinflammation.
Study 2, A twin study of controlled diet
Monozygotic twin pairs will be provided an assigned diet for 14-days.
干预措施: Diet modification (Behavioral)
结局指标
主要结局
Study 1: Hypothalamic Gliosis
时间窗: at enrollment
T2 relaxation time as measured by brain MRI
Study 2: Hypothalamic Gliosis
时间窗: 7 days of diet intervention
T2 relaxation time as measured by brain MRI
次要结局
未报告次要终点
研究者
Ellen Schur, MD, MS
Professor: School of Medicine
University of Washington