Identification of Phenotypic Factors That Predict Success for Weight Loss and Long-term Weight Maintenance

Обзор

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.

Вмешательства

• Другое phenotyping

Первичные конечные точки

• Phenotypic factors related to weight loss and long-term weight maintenance [Срок оценки: Change in phenotypic factors from baseline to 3-6 months and at 2 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Публикации

• Rothberg AE, Marriott DJ, Miller NM, Herman WH. Retention and weight outcomes after transitioning an intensive behavioral weight management program from an in-person to a virtual format. Obes Sci Pract. 2023 Apr 20;9(5):452-458. doi: 10.1002/osp4.673. eCollection 2023 Oct. PMID 37810529
• Rothberg AE, McEwen LN, Kraftson AT, Fowler CE, Herman WH. Very-low-energy diet for type 2 diabetes: an underutilized therapy? J Diabetes Complications. 2014 Jul-Aug;28(4):506-10. doi: 10.1016/j.jdiacomp.2014.03.014. Epub 2014 Mar 29. PMID 24849710

Идентификаторы

NCT: NCT02043457 · HUM00030088

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗