Effect of Liraglutide on Neural Responses to High Fructose Corn Syrup in Individuals With Obesity.
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages.
研究概览
简要总结
To study the effects of liraglutide on neural responses to high fructose corn syrup (HFCS) in individuals with obesity.
详细描述
Adolescents are the highest consumers of sugar sweetened beverages (SSB) potentially because their developing brains are most susceptible to the rewarding neural effects of sugar consumption. Thus, we specifically target this population (adolescents) to understand neural mechanisms involved in excess sugar consumption which predisposes to the development of obesity, prediabetes, and type 2 diabetes.
Upon results entry, the data elements in protocol section of this record were updated to reflect the appropriate study phase and primary purpose that was inadvertently mischaracterized at the time of registration. One of the secondary outcomes was removed because it was a duplicate of the second primary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-39 years old
- •Lean (BMI 18.5-24.9 kg/m2) with normoglycemia
- •Obese (BMI 30-45 kg/m2) with or without prediabetes
- •Weight stable
- •Right handed
- •Able to read and write in English
- •Able to provide written and verbal informed consent
排除标准
- •Current active participation in a weight loss program or weight loss of >=10% of total body weight during the previous 6 months
- •Prior bariatric surgery or current gastric balloon
- •Weight >440lbs or waist circumference >142cm
- •Following a vegetarian/vegan diet or dieting/restricting food
- •Significant medical condition
- •Current use of weight-loss medications or supplements, psychiatric medications or anti- hyperglycemic medications
- •History of or family history of multiple endocrine neoplasia type 1 (MEN-I) or medullary thyroid cancer, alcoholism, or previous history of pancreatitis
- •Females who are pregnant or lactating, or who are unwilling to use proper contraception or remain abstinent,
- •Claustrophobia that would interfere with MRI or metal in their body that would pose a risk in the MRI.
研究组 & 干预措施
obese subjects
Subjects will self-administer Liraglutide once daily for 12 weeks.
干预措施: Liraglutide (Drug)
结局指标
主要结局
Change in Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages.
时间窗: 1 week and 12 weeks
To investigate brain response (using fMRI) to acute consumption of sugar sweetened drinks in obese prediabetic adolescents/young adults (age 18-39 yrs). Measurement at 1 week was compared to measurement at 12 weeks. Increased blood flow in thalamus was monitored in participants as a binary outcome (increase/no increase).
Brain Response in Obese Young Adults Who Drink Sugar Sweetened Beverages.
时间窗: 1 week
To investigate brain response (using fMRI) to acute consumption of sugar sweetened beverages in obese prediabetic adolescents/young adults (age 18-39 yrs), increase in cerebral blood flow was monitored in participants as a binary outcome (increase/no increase).
次要结局
未报告次要终点