Liraglutide Effects on Memory in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: liraglutide

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Luebeck, Germany, 23538
    • University of Luebeck, Department of Neuroendocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liraglutide; See "Intervention"	Drug: liraglutide; 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).; Other Names: Victoza
Placebo Comparator: Placebo; See "Intervention"	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Digit Span Test	Day -7, Day 1, Day 35
Change from baseline in immediate and delayed recall of a procedural memory task at the time points indicated in the "Time Frame" - section.	Finger tapping test	Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 28 (Immediate Recall 2), Day 35 (Delayed Recall 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in resting metabolic rate on day 7, 28 and 35.	indirect calorimetry	Day 0 , Day 7 , Day 28 , Day 35
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

Collaborators and Investigators

• Sponsor: University of Luebeck
• Collaborators: Novo Nordisk A/S
• Investigators: Principal Investigator: Volker Ott, MD, University of Luebeck, Department of Neuroendocrinology

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 7, 2012
• First Posted (Estimate): March 12, 2012

Study Record Updates

• Last Update Posted (Estimate): February 27, 2014
• Last Update Submitted That Met QC Criteria: February 26, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: GLP-1; Liraglutide; Memory; GLP-1 analogue; energy output; Memory facilitation
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: Ott-NN-001