Acipimox Administration Together With Short-Term Exercise Exerts A Co-Feedback of Growth Hormone, Pancreatic Polypeptide, Peptide YY and Leptin on Ghrelin in Young Bulimic Czech Women: A Randomized Study
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 24
- 主要终点
- Changes in plasma growth hormone levels
研究概览
简要总结
This study evaluates the addition of Acipimox or placebo to exercise on growth hormone release and ghrelin secretion in bulimic patients and in healthy women. Two groups of participants will receive Acipimox together with exercise versus identical placebo with exercise.
详细描述
Acipimox and exercise each increase growth hormone release, but they do so by different mechanisms.
Acipimox is an anti-lipolytic drug and increases growth hormone release by decreasing free fatty acids levels and that Acipimox may exert to a negative feedback of growth hormone on ghrelin.
Physical exercise is a potent physiological stimulus for growth hormone release. As ghrelin has a stimulatory effect on growth hormone secretion, growth hormone may inhibit circulating ghrelin levels via a feedback loop. Growth hormone stimulates lipolysis and resultant free fatty acids may suppress ghrelin secretion.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with a diagnosis of bulimia nervosa
- •Body mass index (BMI) between 18 and 23 kg/m2
排除标准
- •History of heart disease
- •History of bleeding disorders
- •Subjects with diabetes type 1 or 2, hypo- or hyperthyroidism
- •Subjects with hepatogastroenteric disease
- •Pregnant, trying to become pregnant or breast feeding
- •Patients with other psychiatric diseases
研究组 & 干预措施
Acipimox
Other Names: Olbetam
干预措施: Acipimox (Drug)
Placebo
Other Names:
Placebo (for Olbetam)
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in plasma growth hormone levels
时间窗: baseline and over a total 2 weeks
Plasma growth hormone (mIU/L) levels will be measured by a commercial RIA kit in the morning and after exercise alone or together with Acipimox administration over a total of 2 weeks.
次要结局
- Changes in extracellular adipose tissue glycerol levels(baseline and over a total 2 weeks)
研究者
Kvido Smitka
M.D., Ph.D.
Charles University, Czech Republic