Clinical trial NCT01550653: Liraglutide Effects on Memory in Healthy Subjects
Official title: Liraglutide Effects on Memory in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Memory
GLP-1
Liraglutide
energy output
Memory facilitation
GLP-1 analogue
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2012-03-12
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 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)
measure: 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.
timeFrame: Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 28 (Immediate Recall 2), Day 35 (Delayed Recall 2)
measure: Change from baseline in performance on a two-dimensional object location task on day 1 and day 35.
timeFrame: Day -7, Day 1, Day 35
measure: Change from baseline in performance on a working-memory task on day 1 and day 35.
timeFrame: Day -7, Day 1, Day 35
measure: Change from baseline in immediate and delayed recall of a procedural memory task at the time points indicated in the "Time Frame" - section.
timeFrame: Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 28 (Immediate Recall 2), Day 35 (Delayed Recall 2)
Secondary outcomes:
measure: Change from baseline in resting metabolic rate on day 7, 28 and 35.
timeFrame: Day 0 , Day 7 , Day 28 , Day 35
measure: Change from baseline in serum/plasma concentrations of parameters involved in glucose metabolism on day 1,7,28, and 35.
timeFrame: Day -7, 1, 7, 28, 35
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: University of Luebeck, Department of Neuroendocrinology
Study officials:
affiliation: University of Luebeck, Department of Neuroendocrinology
name: Volker Ott, MD
role: PRINCIPAL_INVESTIGATOR
References: