Saxenda: Underlying Mechanisms and Clinical Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- BOLD response to food cues
研究概览
简要总结
The purpose of this protocol is to investigate the effect of treatment with the study drug Liraglutide, a GLP-1 receptor agonist, on centers of the brain that control appetite and food intake.
详细描述
The effect of treatment with the study drug Liraglutide, a recently discovered GLP-1 receptor agonist, on centers of the brain that control appetite and food intake will be studied in detail.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obese: BMI> 30 kg/m2 or >27 kg/m2 with comorbidities (including but not limited to insulin resistance, hypertension, dyslipidemia, cardiovascular disease, stroke, sleep apnea, gallbladder disease, hyperuricemia and gout, and osteoarthritis).
排除标准
- •Women who are breastfeeding, pregnant, or wanting to become pregnant.
- •Women using metal IUD
- •Any change in the dosage of hormonal contraceptive medications (birth control pills, implanon). Subjects should remain on same medication/ same dose during the time of the entire study.
- •Moderate (creatinine clearance of 30-59 ml/min) and severe renal impairment (creatinine clearance below 30 ml/min) and end-stage renal disease
- •Moderate, or severe hepatic impairment
- •Hypersensitivity to the active substance or any of the excipients in liraglutide
- •History of diabetic ketoacidosis
- •Congestive heart failure
- •EKG abnormalities (as listed above)
- •Inflammatory conditions like inflammatory bowel disease, Rheumatoid arthritis etc
- •Gastroparesis
- •Pancreatitis
- •Gallstones- as they may cause increased risk of pancreatitis
- •Alcohol consumption- the maximum quantity for men is 140g-210g per week. For women, the range is 84g-140g per week or drinking as consuming no more than two drinks a day for men and one for women. Alcohol can cause increased risk of pancreatitis and hypoglycemia.
- •Untreated thyroid disease like hypothyroidism or hyperthyroidism
- •Subjects taking the following medications: warfarin, steroids (inhaled or systemic due to reduced hypoglycemic effect), and subjects on other hormones (LHRH analogs etc).
- •Subjects on any oral anti-diabetic agent except metformin
- •Personal or family history of MEN II or medullary thyroid cancer
- •Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neuron or biostimulators, electronic infusion pumps, etc.)
- •Subjects with any type of metallic implant that could potentially be displaced or damaged during MRI, such as aneurysm clips, metallic skull plates, surgical implants etc. or metal containing tattoos
- •Anxiety of small spaces and/or claustrophobia
- •Uncontrolled cardiac impairment, circulatory impairment, or inability to perspire (poor thermoregulatory function)
- •Significant sensory or motor impairment
- •Epilepsy, particularly photo-sensitive epilepsy, which may place the individual at a higher risk for adverse events during fMRI scanning with visual stimulation
- •Subjects with neurological or psychological problems which may interfere with or complicate testing (e.g. presence of titubation)
- •Body weight above the limitation of the MRI scanning table (330lbs/150 Kg) or body dimensions that could difficult the performance of the scan.
- •Subjects who cannot adhere to the experimental protocol for any reason
- •Anemia with Hgb less than 10
- •Uncontrolled infectious diseases (e.g. HIV, hepatitis, chronic infections etc)
- •Any uncontrolled endocrine condition, e.g Cushing's, Acromegaly, etc
- •Any cancers or lymphoma
- •Eating disorders like anorexia, bulimia
- •Severe hypertriglyceridemia (triglycerides >500 mg/dl)
- •Weight loss surgery or gastrectomy
- •Any changes in medications that affect brain function, e.g. anti-depressants, anti-psychotics, anti-anxiety, anti-seizure medications, antihypertensives etc (subjects should remain on same medication/ same dose during the time of the entire study).
- •Vegetarians- as food images presented will include numerous non-vegetarian items and thus will not be appealing as high calorie food items.
- •Suicidality, as measured by the MSSI at screening visit.
研究组 & 干预措施
Liraglutide followed by placebo
Participants will receive liraglutide with dose titration over 5 weeks (0.6mg for 1 week, 1.2mg for 1 week, 1.8mg for 1 week, 2.4mg for 1 week, and 3.0mg for 1 week) followed by a minimum of 3 weeks wash-out and then return for the same dose of placebo for the same amount of time.
干预措施: Placebo (Other)
Placebo followed by liraglutide
Participants will receive placebo with dose titration (0.6mg for 1 week, 1.2mg for 1 week, 1.8mg for 1 week, 2.4mg for 1 week, and 3.0mg for 1 week) followed by a minimum of 3 weeks wash-out and then return for the same dose of liraglutide for the same amount of time.
干预措施: Placebo (Other)
Liraglutide followed by placebo
Participants will receive liraglutide with dose titration over 5 weeks (0.6mg for 1 week, 1.2mg for 1 week, 1.8mg for 1 week, 2.4mg for 1 week, and 3.0mg for 1 week) followed by a minimum of 3 weeks wash-out and then return for the same dose of placebo for the same amount of time.
干预措施: liraglutide (Drug)
Placebo followed by liraglutide
Participants will receive placebo with dose titration (0.6mg for 1 week, 1.2mg for 1 week, 1.8mg for 1 week, 2.4mg for 1 week, and 3.0mg for 1 week) followed by a minimum of 3 weeks wash-out and then return for the same dose of liraglutide for the same amount of time.
干预措施: liraglutide (Drug)
结局指标
主要结局
BOLD response to food cues
时间窗: 5 weeks
effect size of BOLD response to food cues in the brain
次要结局
未报告次要终点
研究者
Christos Mantzoros
Professor of Medicine
Beth Israel Deaconess Medical Center