An ObEsity-centric Approach With and Without Anti-obesity Medications ComPared to the Usual-care ApprOach to Management of Patients With Obesity and Type 2 Diabetes in an Employer Setting: A Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Mean Change in Body Weight Between Baseline and 12 Months
研究概览
简要总结
This is a pragmatic, 24 month, single-center, randomized, open-label, parallel-group trial comparing an obesity-centric approach with a medically-supervised and comprehensive weight loss program (Cleveland Clinic's Endocrinology and Metabolism Institute's Integrated Weight Management Program) augmented by AOMs, vs. an obesity-centric approach with a medically-supervised and comprehensive weight loss program without AOMs, vs. the current usual care approach to general health management.
Informed consent will be obtained. IRB approval of the study will be obtained. 300 subjects (employees or spouses covered by our EHP) will be randomized 1:1:1 to receive either an obesity-centric approach with AOM therapy (N=100), an obesity-centric approach without AOM therapy (N=100), or the current usual care approach to general health management (N=100).
详细描述
Obesity affects nearly 40% of adults in the US and it is responsible for important medical problems including hypertension, dyslipidemia, T2D, depression, coronary heart disease, stroke, osteoarthritis, obstructive sleep apnea (OSA), fatty liver disease, and some cancers, to name a few4,5.
Obesity is responsible for the development of T2D and hypertension in more than 90% and 50% of cases, respectively6-7. Also more than 70% of patients with obesity have dyslipidemia. The prevalence of depression in patients with obesity is more than 50% and obesity is responsible for causing osteoarthritis in more than 25% of the patients8. Also, in the adult population, the prevalence of OSA is estimated to be ~25%, and as high as 45% in subjects with obesity9.
Patients with obesity have an increased risk of all-cause and cardiovascular death. In recognition of the biologic basis and seriousness of obesity, several professional health associations and organizations worldwide recognize obesity as a disease10.
Even though there is clear evidence in the literature that weight loss is associated with a dramatic improvement of obesity-related comorbidities and the patient's quality of life, in general, clinicians all over the world focus their attention on treating the diabetes, hypertension, hyperlipidemia and other comorbidities rather than the obesity itself, concentrating their efforts on improving blood glucose indices, blood pressure and LDL as well as triglycerides, and in many instances, prescribing anti-diabetes and antihypertensive medications that potentiate further weight gain11,12. As a result, clinicians are faced with a rising epidemic of obesity, perpetuating a preexisting epidemic of diabetes, hypertension, dyslipidemia, and metabolic syndrome.
Obesity is one of the biggest drivers of preventable chronic diseases and healthcare costs in the United States. Currently, estimates for these costs are $210 billion per year. In addition, obesity is associated with job absenteeism and with lower productivity while at work costing approximately $4.3 billion annually12,13.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender: men and women
- •Ethnicity: all ethnic groups
- •Age: ≥18, < 75 years
- •Diagnosis of T2D -A1C within the last 90 days must be >7.5%
- •Obesity, BMI ≥30
- •An Employee, or the significant other of an employee, that is covered by the Cleveland Clinic Employee Health Plan
排除标准
- •Type 1 diabetes or known latent autoimmune diabetes of adulthood (LADA)
- •Glomerular Filtration Rate <30 mL/min/1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration Equation, CKD-EPI)
- •Current glucocorticoid therapy
- •Currently or within the past 3 months receiving an anti-obesity medication, or any other medication used for the primary intent of weight loss
- •Any condition, unwillingness or inability, not covered by any of the other exclusion criteria, which, in the study clinician's opinion, might jeopardize the subject's safety or compliance with the protocol
- •Mental incapacity or language barrier
- •Pregnancy or plans to become pregnant within the next 2 years
- •Personal or family history of medullary thyroid carcinoma
- •Personal or family history of Multiple Endocrine Neoplasia syndrome type 2
- •History of acute pancreatitis, severe liver disease (Cirrhosis), or severe disease of digestive tract
- •History of congestive heart failure
- •History of bariatric or metabolic surgery/procedure
- •Visit with an endocrinologist within the past 1 year
- •Prior participation in the Endocrinology and Metabolism Institutes Integrated Weight Management Program
研究组 & 干预措施
Obesity-centric approach + AOM
Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately two years. After discussing with the study doctor, participants will receive one of the following listed 4 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) phentermine/topiramate extended-release, 3) naltrexone/bupropion extended-release and 4) liraglutide 3.0 mg
干预措施: Weight Management Program (WMP) (Other)
Obesity-centric approach + AOM
Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately two years. After discussing with the study doctor, participants will receive one of the following listed 4 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) phentermine/topiramate extended-release, 3) naltrexone/bupropion extended-release and 4) liraglutide 3.0 mg
干预措施: Phentermine / Topiramate Extended Release Oral Capsule (Drug)
Obesity-centric approach + AOM
Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately two years. After discussing with the study doctor, participants will receive one of the following listed 4 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) phentermine/topiramate extended-release, 3) naltrexone/bupropion extended-release and 4) liraglutide 3.0 mg
干预措施: naltrexone/bupropion extended-release (Drug)
Obesity-centric approach + AOM
Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately two years. After discussing with the study doctor, participants will receive one of the following listed 4 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) phentermine/topiramate extended-release, 3) naltrexone/bupropion extended-release and 4) liraglutide 3.0 mg
干预措施: liraglutide 3.0 mg (Drug)
Obesity-centric approach + AOM
Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately two years. After discussing with the study doctor, participants will receive one of the following listed 4 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) phentermine/topiramate extended-release, 3) naltrexone/bupropion extended-release and 4) liraglutide 3.0 mg
干预措施: Orlistat (Drug)
Obesity-centric approach without AOM
Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately two years.
干预措施: Weight Management Program (WMP) (Other)
Usual care approach (Comorbidity-centric approach)
Participants will receive the traditional usual care/standard of care approach to T2D, hypertension, hypercholesterolemia management for approximately two years.
干预措施: Traditional care (Other)
结局指标
主要结局
Mean Change in Body Weight Between Baseline and 12 Months
时间窗: 12 Months
All relevant time points used in the calculation in the Time Frame between baseline and 12 months. Measured in the mean Change in body weight between baseline and 12 months measured in percentage (%) of body weight loss
Mean Change in A1C
时间窗: 12 Months
All relevant time points used in the calculation in the Time Frame between baseline and 12 months. Measured in the mean change of the percentage of glycosylated hemoglobin from baseline to 12 months
次要结局
未报告次要终点
研究者
Bartolome Burguera
Principal Investigator
The Cleveland Clinic