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Liraglutide Effects on Memory in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01550653
First Posted: March 12, 2012
Last Update Posted: February 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Dr. med. Volker Ott, University of Luebeck
  Purpose
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.

Condition Intervention Phase
Healthy Drug: liraglutide Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Liraglutide Effects on Memory in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Dr. med. Volker Ott, University of Luebeck:

Primary Outcome Measures:
  • 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Day -7, Day 1, Day 35 ]
  • Change from baseline in performance on a working-memory task on day 1 and day 35. [ Time Frame: 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. [ Time Frame: 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:
  • Change from baseline in resting metabolic rate on day 7, 28 and 35. [ Time Frame: 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. [ Time Frame: Day -7, 1, 7, 28, 35 ]

Enrollment: 40
Study Start Date: May 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Victoza
Placebo Comparator: Placebo
See "Intervention"
Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550653


Locations
Germany
University of Luebeck, Department of Neuroendocrinology
Luebeck, Germany, 23538
Sponsors and Collaborators
University of Luebeck
Novo Nordisk A/S
Investigators
Principal Investigator: Volker Ott, MD University of Luebeck, Department of Neuroendocrinology
  More Information

Responsible Party: Dr. med. Volker Ott, Principal Investigator, University of Luebeck
ClinicalTrials.gov Identifier: NCT01550653     History of Changes
Other Study ID Numbers: Ott-NN-001
First Submitted: March 1, 2012
First Posted: March 12, 2012
Last Update Posted: February 27, 2014
Last Verified: February 2014

Keywords provided by Dr. med. Volker Ott, University of Luebeck:
Memory
GLP-1
Liraglutide
energy output
Memory facilitation
GLP-1 analogue

Additional relevant MeSH terms:
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists