暴食与节育
连续周期口服避孕药在暴食中的机制检验
研究概览
详细说明
饮食失调 (ED) 影响了美国 1500 万女性,是所有精神疾病中死亡率最高的疾病之一。 尽管如此,潜在的神经生物学仍然知之甚少。 ED 主要发生在女性身上,并且某些症状的频率在月经周期内以可预测的模式发生变化;具体而言,症状变化似乎是由卵巢激素雌二醇 (E2) 和黄体酮 (P4) 的正常波动引发的。
本研究的目的是通过连续服用口服避孕药 (OC) 3 个月来检查卵巢激素稳定对暴饮暴食女性 (n=15) 响应奖赏和饮食行为的大脑激活的影响使用功能磁共振成像 (fMRI) 和行为测试。 OCs 通过抑制排卵起作用,从而减少排卵前后发生的 E2 和 P4 变化。 因为传统的 21/7 OC 给药方案(21 粒活性药丸随后 7 天非活性药丸)允许卵泡开始发育,这导致内源性 E2 的分泌,然后一旦活性药丸再次开始,E2 就会停止。 这不会导致一致的稳定。 因此,本研究将连续使用 OC,不使用无活性药丸。
参与者将在 OC 管理之前和 OC 管理结束时完成 fMRI 成像和自我报告问卷。 研究人员将检查在 OC 管理下这些措施中发生的受试者内部变化。 主要假设是持续的 OC 治疗将对感兴趣的结果产生有益/稳定的影响。 具体来说,使用 OC 可能会减少症状。 结果最终将为更大规模的机械试验提供必要的试验数据。
具体目标是:
目标 1:量化卵巢激素稳定对暴食女性饮食行为的影响。
目标 2:使用 fMRI 和自我报告问卷检查暴食女性的卵巢激素稳定对奖赏反应的影响。
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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North Carolina
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Chapel Hill、North Carolina、美国、27599
- University of North Carolina at Chapel Hill
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准
参与者将包括 18-34 岁的女性,其当前的诊断和统计手册 (DSM-5) 诊断为暴食综合症且月经周期规律。 只有能够给予知情同意并理解与研究相关的风险的参与者才会被招募。
- 目前的暴食行为符合暴食综合症的 DSM-5 标准
- 18-34岁
- 月经周期至少3个月
- 没有影响卵巢激素的药物或医疗状况,或禁忌用于研究干预(包括节育)
- 说英语
排除标准
- 安全问卷确定的您体内的任何异物或植入物(由于 fMRI)
- 在过去 3 个月内使用避孕药或激素
- 植入的激素避孕药(即 孕激素宫内节育器或植入物)
- 当前怀孕、哺乳或产后 < 12 周
- 以前对节育有严重的负面反应
- 当前吸烟者
- < 18.5 体重指数 > 31
- 双相情感障碍或精神病发作史
- 经常使用泻药和/或利尿剂
- 以前的自杀未遂
- 异常/未确诊的阴道出血;子宫内膜异位症
- 反复发作的偏头痛或伴有局灶性神经系统症状的头痛
- 高血压或血管疾病(即冠状动脉疾病、充血性心力衰竭、脑血管疾病)
- 糖尿病或其他循环问题
- 凝血障碍
- 卟啉症
- 乳腺癌、子宫/子宫颈癌或阴道癌
- 增加血清钾水平的医疗状况或药物使用(包括频繁使用泻药或利尿剂)
- 高胆固醇
- 静脉血栓栓塞 (VTE)、深静脉血栓形成、肺栓塞、静脉血栓形成、冠状动脉血栓形成、血栓栓塞、血栓性静脉炎或任何类型的血栓或血栓疾病(例如,血栓栓塞性疾病、因子 V Leiden)、蛋白 C 或 S 缺乏病史、心脏病发作或中风、心房颤动、心脏、肝脏、肾脏或肾上腺疾病、心内膜炎、肝癌、恶性黑色素瘤、胆囊炎或胰腺炎、妊娠或避孕药引起的静脉血栓栓塞症或黄疸、近期长时间不能活动(例如,怀孕卧床休息),有遗传性凝血障碍的直系家族史
- 孕妇将被排除在参与之外,怀孕的妇女(尽管不太可能)将被退出。 在注册之前,将完成妊娠测试。 在本研究期间,所有参与者都将被要求使用非激素形式的避孕措施(例如,屏障方法)以避免怀孕。 如果女性在研究期间怀孕,将停止参与。
- 研究团队认为对受试者安全产生不利影响的任何状况或症状。
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:连续超频
连续每天口服屈螺酮 + 炔雌醇 84 天(即 12 周)。
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3毫克-0.03
Mg 连续每日屈螺酮-乙炔雌二醇。
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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每周平均暴食频率从干预前到干预终点的变化
大体时间:干预前(第 1 周)到干预终点(第 12 周)
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暴食频率基于自我报告的暴食频率的每周日记。
参与者被问及他们在过去一周内暴食了多少次。
分数范围从 0 到无穷大,因为频率是自我报告的前一周暴食事件的次数。
分数越高表示暴食的次数越多。
变化被定义为自我报告的暴饮暴食频率从干预前到干预的平均变化。
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干预前(第 1 周)到干预终点(第 12 周)
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暴食总分从干预前到干预终点的变化
大体时间:干预前(第 1 周)到干预终点(第 12 周)
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暴食将使用饮食病理学症状量表 (EPSI) 的 8 项暴食子量表进行测量,该量表以 5 分李克特量表测量暴食的特征(例如,大量食物的消耗,盲目进食) “从不”到“经常”。
EPSI 量表旨在评估过去 28 天的行为。
项目被总结为范围从 0-32 的量表分数。
分数越高表明暴食行为的经历越频繁。
变化定义为从干预前到干预期间暴食量表评分的平均变化。
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干预前(第 1 周)到干预终点(第 12 周)
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货币激励延迟任务 (MIDT) 期间伏隔核信号强度从预干预到干预终点的变化对奖励的反应
大体时间:干预前(第 1 周)到干预终点(第 12 周)
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比较治疗前后的货币激励延迟 (MIDT) 任务期间伏隔核 (NAcc) 对奖励的反应性。
在 MIDT 任务期间,参与者通过在看到目标时尽快按下 MRI 按钮盒上的按钮来响应“获胜”试验。
反应性是通过检查参与者的血氧水平依赖性 (BOLD) 变化来测量的(即测量由红细胞携带到神经元的氧气水平,因为大脑区域被认为更“活跃”或参与某些任务需要更多的氧气)以响应感兴趣的刺激(获胜试验)与非刺激(非获胜试验)。
货币奖励与非奖励之间 BOLD 激活的百分比信号变化是感兴趣的结果。
然后比较处理前和处理后的信号变化百分比。
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干预前(第 1 周)到干预终点(第 12 周)
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在货币激励延迟任务 (MIDT) 期间,背侧纹状体信号强度从干预前到干预终点的变化响应奖励
大体时间:干预前(第 1 周)到干预终点(第 12 周)
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与治疗前后相比,货币激励延迟 (MIDT) 任务期间奖励的背侧纹状体反应性(定义为尾状核信号强度和壳核信号强度)。
在 MIDT 任务期间,参与者通过在看到目标时尽快按下 MRI 按钮盒上的按钮来响应“获胜”试验。
反应性是通过检查参与者的血氧水平依赖性 (BOLD) 变化来测量的(即测量由红细胞携带到神经元的氧气水平,因为大脑区域被认为更“活跃”或参与某些任务需要更多的氧气)以响应感兴趣的刺激(获胜试验)与非刺激(非获胜试验)。
货币奖励与非奖励之间 BOLD 激活的百分比信号变化是感兴趣的结果。
然后比较处理前和处理后的信号变化百分比。
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干预前(第 1 周)到干预终点(第 12 周)
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货币激励延迟任务 (MIDT) 期间前额叶皮层信号强度从预干预到干预终点的变化对奖励的反应
大体时间:干预前(第 1 周)到干预终点(第 12 周)
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比较治疗前后的货币激励延迟 (MIDT) 任务期间前额叶皮层对奖励的反应性。
在 MIDT 任务期间,参与者通过在看到目标时尽快按下 MRI 按钮盒上的按钮来响应“获胜”试验。
反应性是通过检查参与者的血氧水平依赖性 (BOLD) 变化来测量的(即测量由红细胞携带到神经元的氧气水平,因为大脑区域被认为更“活跃”或参与某些任务需要更多的氧气)以响应感兴趣的刺激(获胜试验)与非刺激(非获胜试验)。
货币奖励与非奖励之间 BOLD 激活的百分比信号变化是感兴趣的结果。
然后比较处理前和处理后的信号变化百分比。
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干预前(第 1 周)到干预终点(第 12 周)
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延迟贴现参数k从干预前到干预终点的变化
大体时间:干预前(第 1 周)到干预终点(第 12 周)
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货币选择问卷将用于衡量延迟贴现。
参与者将被要求在较小的、较早的(冲动的)与较大的、较晚的(自我控制的)假设货币结果之间做出一系列假设选择。
k 是一个双曲线函数,k 值越大表示对较大的延迟奖励的估值越高,值越小表示对更直接、更小的奖励(更冲动)的偏好。
k 的范围从 0 到 0.25,0.25 表示立即奖励的完整估值,0 表示较大的延迟奖励的完整估值。
变化被定义为 k 从干预前到干预的平均变化。
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干预前(第 1 周)到干预终点(第 12 周)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
自我报告的奖励敏感性子量表分数从干预前到干预终点的变化
大体时间:干预前(第 1 周)到干预终点(第 12 周)
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惩罚敏感度/奖励敏感度调查问卷将用于衡量奖励敏感度。
将使用奖励敏感度分量表,该分量表以真/假量表评分,分数范围为 0-24。
分数越高表示对奖励越敏感。
变化被定义为从干预前到干预的奖励敏感性的平均变化。
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干预前(第 1 周)到干预终点(第 12 周)
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行为抑制子量表评分从干预前到干预终点的变化
大体时间:干预前(第 1 周)到干预终点(第 12 周)
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行为抑制/行为激活问卷将用于评估行为抑制 (BI)。
BI 子量表的最低分数为 7,最高为 28。
更高的分数表示更高的 BI。
变化被定义为从干预前到干预的 BI 的平均变化。
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干预前(第 1 周)到干预终点(第 12 周)
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合作者和调查者
调查人员
- 首席研究员:Jessica Baker, PhD、University of North Carolina, Chapel Hill
出版物和有用的链接
一般刊物
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研究记录日期
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研究完成 (实际的)
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首先提交符合 QC 标准的
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与本研究相关的术语
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- 19-3149
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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IPD 共享时间框架
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暴饮暴食症的临床试验
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Hospital Universitari Vall d'Hebron Research InstituteInstituto de Salud Carlos III完全的
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Dren BioNovotech招聘中侵袭性 NK 细胞白血病 | 肝脾T细胞淋巴瘤 | 肠病相关的T细胞淋巴瘤 | 皮下脂膜炎样 T 细胞淋巴瘤 | 单形性趋上皮性肠 T 细胞淋巴瘤 | LGLL - 大颗粒淋巴细胞白血病 | 原发性皮肤 T 细胞淋巴瘤 - 类别 | 原发性皮肤 CD8 阳性侵袭性嗜表皮 T 细胞淋巴瘤 | 系统性 EBV1 T 细胞淋巴瘤,如果 CD8 阳性 | Hydroa Vacciniforme-Like Lymphoproliferative Disorder | 结外 NK/T 细胞淋巴瘤,鼻型 | 胃肠道惰性慢性淋巴增生性疾病 (CLPD)(CD8+ 或 NK 衍生) | 上面未列出的其他 CD8+/NK 细胞驱动的淋巴瘤美国, 澳大利亚, 法国, 西班牙
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Memorial Sloan Kettering Cancer Center招聘中蕈样肉芽肿 | 塞扎里综合症 | 血管免疫母细胞性T细胞淋巴瘤 | 肝脾T细胞淋巴瘤 | 间变性大细胞淋巴瘤,ALK 阳性 | 结外 NK/T 细胞淋巴瘤,鼻型 | T细胞淋巴瘤 | 未特指的外周 T 细胞淋巴瘤 | 原发性皮肤间变性大细胞淋巴瘤 | 皮下脂膜炎样 T 细胞淋巴瘤 | 肠病相关的T细胞淋巴瘤 | 间变性大细胞淋巴瘤,ALK 阴性 | 单形性趋上皮性肠 T 细胞淋巴瘤 | T 细胞幼淋巴细胞白血病 | T 细胞大颗粒淋巴细胞白血病 | 原发性皮肤 CD8 阳性侵袭性嗜表皮 T 细胞淋巴瘤 | Hydroa Vacciniforme-Like Lymphoproliferative Disorder | NK细胞淋巴瘤 | 侵袭性 NK 细胞白血病 | 成人 T 细胞白血病/淋巴瘤 及其他条件美国