EUCTR2011-000753-24-NL进行中（未招募）不适用
Central effects of endogenous GLP-1 and the GLP-1 analog liraglutide on brain satiety and reward circuits and feeding behavior in diabetes. - LIBRA
VU University Medical Center0 个研究点开始时间: 2011年7月6日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •For the healthy, lean individuals:
- •- Age 18–65 years
- •- Women: post menopausal (excluding possible menstruation cycle effects)
- •- Body-mass index (BMI) of <25 kg/m2,
- •- Stable bodyweight (<5% reported change during the previous 3 months).
- •- Normal fasting and 2h postload glucose as ascertained during a 75-g oral glucose tolerance test (OGTT)
- •- Right handed
- •For the obese individuals scheduled for gastric bypass surgery:
- •-Age 18–65 years
- •- Women: preferably post menopausal (excluding possible menstruation cycle effects)
- •- Body-mass index (BMI) of >30 kg/m2,
- •- Stable bodyweight (<5% reported change during the previous 1 months).
- •- Normal or impaired fasting and 2h post load glucose as ascertained during a 75-g oral glucose tolerance test (OGTT) (defined normal; fasting < 5.6 mmol/l and after OGTT t=120min. < 7.8 mmol/l, impaired; fasting 5.7-7.1 mmol/l and after OGTT t=120min 7.9-11.0 mmol/l)
- •- Right handed
- •For the obese individuals with T2DM:
- •- Age 18-65 years
- •- Women: post menopausal (excluding possible menstruation cycle effects)
- •- BMI 25–40 kg/m2
- •- Stable bodyweight (<5% reported change during the previous 3 months).
- •- Diagnosed with T2DM > 3 months prior to screening
- •- HbA1C 6.5–8.5%
- •- Treatment with metformin at a stable dose for at least 3 months.
- •- Right handed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- GLP-1 based therapies, thiazolidinediones, sulphonylurea or insulin within 3 months before screening
- •- Weight-lowering agents within 3 months before screening.
- •- Congestive heart failure (NYHA II-IV)
- •- Chronic renal failure (glomerular filtration rate < 60 mL/min/1.73m2 per Modification of Diet in Renal
- •Disease (MDRD))
- •- Liver disease
- •- History of gastrointestinal disorders (including gastroparese, pancreatitis and cholelithiasis)
- •- Neurological illness
- •- Malignancy
- •- History of major heart disease
- •- History of major renal disease
- •- Pregnancy or breast feeding
- •- Implantable devices
- •- Substance abuse
- •- Addiction
- •- Contra-indication for MRI, such as claustrophobia or pacemaker
- •- Any psychiatric illness; including eating disorders and depression
- •- Chronic use of centrally acting agents or glucocorticoids within 2 weeks immediately prior to screening.
- •- Use of cytostatic or immune modulatory agents
- •- History of allergy for acetaminophen.
- •- History of allergy for insulin analog
- •- History of allergy for liraglutide or other GLP-1 RA/analog
- •- Participation in other studies
- •- Individuals who have received treatment within the last 30 days with a drug that has not received
- •regulatory approval for any indication at the time of study entry
- •- Individuals who are investigator site personnel, directly affiliated with the study, or are immediate family
- •of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse,
- •parent, child, or sibling, whether biological or legally adopted.
- •- Individuals who have previously completed or withdrawn from this study or any other study investigating
- •GLP-1 receptor agonist or dipeptidyl peptidase (DPP)-4 within 6 months
- •- Left handed.
- •- Individuals who, in the opinion of the investigator, are unsuitable in any other way to participate in this
- •- Individuals who are employed by NovoNordisk & comp. (that is, employees, temporary contract workers,
- •or designees responsible for conducting the study).
- •- Poor commandment of the Dutch language or any (mental) disorder that precludes full understanding
- •the purpose, instruction and hence participation in the study.
- •- Further exclusion criteria will be in compliance with the EMeA SPC of liraglutide.
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