Identification of Phenotypic Factors That Predict Success for Weight Loss and Long-term Weight Maintenance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,200
- 试验地点
- 2
- 主要终点
- Phenotypic factors related to weight loss and long-term weight maintenance
研究概览
简要总结
The Investigational Weight Management Clinic now entitled the Weight Management Program at the University of Michigan was created to identify strategies that will result in cost-effective, long term weight management for overweight and obese individuals. The driving hypothesis of the clinic is that the 'one size fits all' philosophy is untenable with a complex disease such as obesity. The clinic will serve as a portal for patients to choose standard clinical care or to explore alternatives from a variety of clinical studies offered through the clinic. These studies will include further investigations into nutrition, the biological basis of weight and weight management and protocols using approved and experimental pharmaceuticals as well as technologies that aid in self-management of weight.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obese males and females: age >20 years; Obese population defined as BMI > or = 27 kg/m2
- •Lean population BMI < 27 but > 17 kg/m2
- •Able and willing to provide written informed consent for the trial
排除标准
- •Evidence of inherited disorders of lipid metabolism.
- •History of Cancer within the last 5 years
- •Human immunodeficiency virus (HIV) antibody positive.
- •Patients with solid organ transplants.
- •Participation in any other clinical trial within 90 days of entry into this trial.
- •Pregnant or lactating females.
- •Uncontrolled thyroid disease
- •Unstable angina or NY heart association class II failure or above
- •Gastrointestinal disease specifically GI motility disorders
- •Unstable neuropsychiatric disease including major depression/anxiety, eating disorder such as binge eating, bulimia or anorexia
- •End stage renal or hepatic disease
- •Autoimmune disorders (e.g. SLE)
- •Body weight fluctuation of more than 5 kg in the previous 3 months
- •Prior bariatric surgery
- •A history or current alcohol/substance abuse and change in smoking habits or cessation in the past 6 months.
- •Women of childbearing age must use a reliable form of contraception.
- •Any medical condition, which in the opinion of the investigator would make the patient unsuitable for recruitment, or could interfere with the patient participating in or completing the protocol.
- •Unwilling or unable to consent for the study.
研究组 & 干预措施
Lifestyle intervention
Opt-in intervention to include the following procedures, called 'phenotyping' performed at baseline, after 10-15% weight loss from baseline weight or 6 months (whichever comes first) and at end of 2 years while in weight maintenance: oral glucose tolerance test, mixed meal tolerance test, with fasting leptin, biased and unbiased metabolomic profiling, DNA, RNA, muscle and adipose tissue biopsies: measurement of resting energy expenditure by indirect calorimetry; oxidative capacity (V02 peak/max); body composition by Dual Energy X-ray Absorptiometry (DEXA) or air displacement plethysmograph (Bod Pod); inventories of depression and health related quality of life instruments, measures of impulsivity, measures of hunger and appetite, work performance (including presenteeism and absenteeism) and pain survey.
干预措施: phenotyping (Other)
结局指标
主要结局
Phenotypic factors related to weight loss and long-term weight maintenance
时间窗: Change in phenotypic factors from baseline to 3-6 months and at 2 years
Phenotypic factors include: blood glucose levels, lipomic/metabolomic measurements, genetic analysis, body fat percentage, maximal oxygen consumption, respiratory quotient, resting metabolic rate, physical/emotional health
次要结局
未报告次要终点
研究者
Amy E Rothberg
Professor of Internal Medicine
University of Michigan