Neurobehavioral Contribution to Weight Loss Maintenance: an Interdisciplinary Experimental Study With Noninvasive Brain Modulation
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change in weight from week 11 to 26
研究概览
简要总结
This is a study of overweight men and women. Everybody will receive a very low calorie diet to eat in place of meals for 10 weeks. During the last two weeks of the diet, half of the patients will receive an intervention to activate parts of their brain that can help them eat less. The other half of the patient will receive a placebo or sham intervention. The intervention will involve a small electric current given every day for 10 days. Everybody will be monitored for 16 more weeks (total of 26 weeks) while on a weight maintenance diet to see if the intervention helps people keep the weight off.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age 20-55 years old
- •BMI 30-50 kg/m2
- •Willing to undergo 10 week supervised VLCD
排除标准
- •Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of weight loss surgery
- •Subjects who have a known history of diabetes, fasting blood sugar >125 mg/dl or using any anti-diabetic drugs
- •Changes in lipid lowering or anti-hypertensive regimen within 3 months of screening
- •Hemoglobin <10 g/dL, Creatinine >1.5 mg/dL
- •QT interval >440 ms on EKG
- •Subjects with unstable psychiatric conditions as assessed by a psychologist
- •Allergy or intolerance to components of the mixed meal challenge
- •Additional contraindications to receive transcranial direct current stimulation (tDCS):
- •Personal or family history of seizures, epilepsy or other unexplained loss of consciousness.
- •Current or past history of skin disease or damaged skin on the scalp at the site of stimulation (i.e. eczema, skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.).
- •Prior neurosurgical procedure or radiation treatment to the brain.
- •Known diagnosis of brain lesions, such as tumor, stroke or multiple sclerosis
- •Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, ventriculoperitoneal shunt or any metallic implant on the head.
- •(Note: Intake of centrally acting medications will be allowed, as there is no evidence that any medication can increase the risk of adverse effects during tDCS.)
- •Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit
- •Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient
结局指标
主要结局
Change in weight from week 11 to 26
时间窗: Week 11 to 26
Patients will be placed on a very low calorie diet from baseline to week 11. The primary end point is the maintenance of weight loss from week 11 to week 26 after the very low calorie diet is stopped.
次要结局
- Change in metabolic parameters(Week 0 to 8, 11, 18, 26)
- Change in appetite(Week 0 to 8, 11, 18 and 26)
- Change in body composition(Week 0 to 8 and 26)
- Change in appetite hormones on mixed meal challenge test(Week 0 to 8, 11 and 26)
研究者
Takara Stanley, M.D.
Assistant Professor of Pediatrics
Massachusetts General Hospital