Status | Acronym | ISRCTN | EudraCT | NCT (clinicaltrials.gov) | DRKS |
---|---|---|---|---|---|
Active (Recruitment Closed) |
Physiological effect of Glp-1 receptor activation on reward and effort learning in obesity
Purpose / Objectives
Primary Outcome
(1) The first aim of this study is to determine whether prediction errors in reward learning are altered in obesity and if Glp-1 receptor activation affects this learning process as a possible mechanism contributing to reduced food intake under Glp-1 analogues in normal weight and obesity.
(2) On a behavioral level, the second aim of this study is to determine whether Glp-1 receptor activation alters the motivation to spend effort for food or monetary rewards in normal weight and obesity.
Diagnosis
- Obesity
- Healthy Volunteers
Target population
Age
20-40
Inclusion criteria
- Informed consent obtained
- Non-smoker (for the last 1 year not smoked more than 2 cigarettes per month)
- Stable body weight (less than 5% self-reported change within the last 3 months)
- Lean subjects with a BMI between 20-25 kg/m2 (healthy weight range)
- Obese subjects with a BMI above 30 kg/m2
Exclusion criteria
- Serious or unstable medical illness (e.g., cancer). Past or current history of alcoholism or consistent drug use. Current and history of major psychiatric illness as defined by the DSM-IV criteria including eating disorders
- Medications that affect alertness (e.g., barbiturates, benzodiazepines, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.) and any psychoactive drugs or anti-obesity agents
- History of major head trauma with loss of consciousness
- Pregnancy
- Nursing women
- Kidney insufficiency (Kreatinin- Clearance <30 ml/min)
- Reduced liver functioning
- History of quincke edema
- Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
- Personal history of non-familial medullary thyroid carcinoma
- History of acute or chronic pancreatitis
- Any known food allergy, certain food sensitivities (lactose); allergy towards active ingredient
- History of metalworking, injury with shrapnel or metal slivers, and major surgery
- History of pacemaker or neuro stimulator implantation
- Dysphagia
- Weight >150 kg
Study design
- Single center
- Prospective
- Single-blind
- Cross-over
- Placebo-controlled
Intervention
One dose of 0.6 mg Liraglutid resp. placebo sc.
Documents (password protected)
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Responsibilities in overall study
Sponsor
Max-Planck-Institut (MPI) für Stoffwechselforschung
- Tel. +49 221 4726-0
- Fax +49 221 4726-298
Sponsor representative
Dr. rer. medic. Kerstin Albus
- Tel. +49 (0)221 478 88798
- Fax +49 221 478 1425263
- kerstin.albus@uk-koeln.de
Dr. Ruth Hanßen
- Tel. +49 221 478 32198
- ruth.hanssen@uk-koeln.de
Prof. Dr. Marc Tittgemeyer
- Tel. +49 221-4726-215
- Fax +49-221-4726-334
- tittgemeyer@sf.mpg.de
Patrick Weyer
(National) Coordinating Investigator
Prof. Dr. med. Jens Brüning
Project management
Institut für Translationale Forschung
Dr. rer. medic. Kerstin Albus
Data management
Max-Planck-Institut (MPI) für Stoffwechselforschung
- Tel. +49 221 4726-0
- Fax +49 221 4726-298