Liraglutide Effects on Memory in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: liraglutide; Drug: Placebo

• Registration Number: NCT01550653
• Lead Sponsor: University of Luebeck

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-12
• Study Start: 2012-05
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liraglutide	liraglutide	See "Intervention"
Placebo	Placebo	See "Intervention"

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Luebeck, Department of Neuroendocrinology; 🇩🇪 Luebeck, Germany