ISRCTN11049554已完成未知
Feasibility and stability of weight loss elicited by an intensified treatment program in patients who are overweight or obese: neuroendocrine and molecular mechanisms
Ministry of Economy and Competitiveness (Ministerio de Economía y Competitividad)0 个研究点目标入组 160 人开始时间: 2016年1月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 160
研究概览
简要总结
2021 Results article in https://doi.org/10.1111/jch.14392 (added 13/02/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age between 18 and 70 years
- •2. Body mass index = 27 and < 35 Kg/m2
- •3. Steady body mass, with a fluctuation below 3% during the past six months
- •4. Non-smoker or smoking < 6 cigarettes per day
排除标准
- •1. Unable or unwilling to give written informed consent or communicate with study staff
- •2. Inability to attend the scheduled visits (lack of autonomy, lack of a permanent address, travel plans, or other reasons)
- •3. Impossibility to follow the recommended diet (for religious reasons, swallowing disorders, allergies, or other reasons)
- •4. Body weight loss > 3% of their body weight during the six months preceding the screening visit.
- •5. History of very-low-caloric diet during the six months before the screening visit
- •6. Intention to undergo bariatric surgery in the next six months
- •7. Prior bariatric surgery
- •8. Obesity of known endocrine origin
- •9. Cardiovascular disease including angina, myocardial infarction, coronary revascularization procedures, stroke (either ischemic or haemorrhagic, including transient ischemic attacks), symptomatic peripheral artery disease, ventricular arrhythmia, uncontrolled atrial fibrillation, congestive heart failure, hypertrophic cardiomyopathy, history of aortic aneurism, and pacemaker carriers
- •10. Major surgery (i.e., surgery requiring hospitalization) during the last twelve months
- •11. Active cancer or history of malignancy within the last five years (except non-melanoma skin cancer or differentiated thyroid cancer)
- •12. History of inflammatory bowel disease or small bowel resection
- •13. Liver cirrhosis or chronic renal failure stages 3B, 4 and 5
- •14. Immunodeficiency or HIV-positive status
- •15. Psychiatric disorders: schizophrenia, bipolar disease, eating disorders, depression with hospitalization in past six months
- •16. History of major organ transplantation
- •17. Current treatment with systemic corticosteroids, immunosuppressive drugs or cytotoxic agents
- •18. History in the past six months or current use of weight loss medication, specifically glucagon-like receptor agonist or inhibitors of sodium–glucose cotransporters. The use of metformin in stable dosage is allowed
- •19. Respiratory insufficiency
- •20. Current carrier of an orthopaedic prosthesis
- •21. Illiteracy
- •22. Alcohol (total daily alcohol daily intake >50 g) or drug abuse within the past six months
- •23. Any other condition that may contraindicate exercise or interfere with the completion of the study protocol
研究者
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