Healthy
Conditions
Keywords
Memory, GLP-1, Liraglutide, energy output, Memory facilitation, GLP-1 analogue
Brief summary
This study examines the hypothesis, that subcutaneous administration of liraglutide, an analogue of the incretin glucagon-like peptide 1, over 5 weeks improves memory functions in healthy humans.
Interventions
DRUGliraglutide
Subcutaneous self-administration of liraglutide(Victoza)by pen. The starting dose is 0.6 mg once daily(day 0 to 7), followed by 1.2 mg once daily (day 8 to 35).
DRUGPlacebo
Sponsors
Novo Nordisk A/S
University of Luebeck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Male sex * Age 18-35 years * Body mass index between 19 and 25 kg/m2 * Non-smoker
Exclusion criteria
* Receipt of any drug within 4 weeks prior to this trial * Any known acute or chronic disease of the brain, heart, lung, kidney,liver, pancreas or gastrointestinal tract, any metabolic, endocrine or psychiatric disease. * Brady- and Tachycardia, i.e. heart rate \< 50 and \> 90 beats per minute. * Hypertension (systolic blood pressure \> 150 mmHg, diastolic blood pressure \> 90 mmHg). * Hyperlipidemia (cholesterol, LDL, triglyceride \> two times the upper reference limit based on analysis from the central laboratory) * Impaired hepatic function measured as alanine aminotransferase (ALAT) \> two times the upper reference limit based on analysis from the central laboratory * Impaired renal function measured as creatinine \> 120 µmol/l based on analysis from the central laboratory * Family history of diabetes * History of any eating disorder * Known or suspected allergy to trial products * History of drug or alcohol abuse within the last five years prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the immediate and delayed recall of a declarative memory task (word list recall) at time points indicated in time frame section. | Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 1 (Immediate Recall 2), Day 7 (Delayed Recall 2), Day 28 (Immediate Recall 3), Day 35 (Delayed Recall 3) | — |
| Change from baseline in the immediate and delayed recall of an Episodic Memory Task (story recall) at the time points indicated in the Time Frame - section. | Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 28 (Immediate Recall 2), Day 35 (Delayed Recall 2) | — |
| Change from baseline in performance on a two-dimensional object location task on day 1 and day 35. | Day -7, Day 1, Day 35 | — |
| Change from baseline in performance on a working-memory task on day 1 and day 35. | Day -7, Day 1, Day 35 | Digit Span Test |
| Change from baseline in immediate and delayed recall of a procedural memory task at the time points indicated in the Time Frame - section. | Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 28 (Immediate Recall 2), Day 35 (Delayed Recall 2) | Finger tapping test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in resting metabolic rate on day 7, 28 and 35. | Day 0 , Day 7 , Day 28 , Day 35 | indirect calorimetry |
| Change from baseline in serum/plasma concentrations of parameters involved in glucose metabolism on day 1,7,28, and 35. | Day -7, 1, 7, 28, 35 | — |
Countries
Germany
Outcome results
None listed