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Effects of Liraglutide on Hippocampal Structure and Function in Aging Adults With Prediabetes (LGT)

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.
 
ClinicalTrials.gov Identifier: NCT02140983
Recruitment Status : Completed
First Posted : May 16, 2014
Last Update Posted : January 25, 2018
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Natalie Rasgon, Stanford University

Brief Summary:

The purpose of this study is to evaluate the effects of liraglutide on the memory and attention of people with insulin resistance. Liraglutide is a medication that makes the body more sensitive to insulin, and therefore may allow it to manage sugar more effectively.

The investigators are looking specifically at a region of the brain that is associated with memory and attention, called the hippocampus, in order to see whether treatment this treatment will change performance on memory and attention tasks. The investigators are also taking an MRI of the brain to see whether there are changes to the size and shape of the hippocampus after treatment.

All subjects in this study will be 50-70 years old and have pre- diabetes. Half of all subjects will have a family history of dementia, while the other half will not.


Condition or disease Intervention/treatment Phase
Insulin Resistance Dementia Drug: Liraglutide Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effects of Liraglutide on Hippocampal Structure and Function in Aging Adults With Prediabetes
Actual Study Start Date : August 2013
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia Prediabetes
Drug Information available for: Liraglutide

Arm Intervention/treatment
Active Comparator: Liraglutide
90 days of liraglutide treatment at adjusting dose, up to 1.8mg/day
Drug: Liraglutide
90 days of liraglutide up to 1.8mg/day.
Other Name: Victoza

Placebo Comparator: Placebo
90 days of placebo pen, up to 1.8mg/day.
Drug: Placebo
Placebo medication




Primary Outcome Measures :
  1. Cognitive Outcomes [ Time Frame: Change from Baseline to 3 months ]
    The following battery of tests will take approximately 90 minutes (at both baseline and 12-week follow-up) to complete and will be administered during the afternoon to avoid diurnal effects: Auditory Consonant Trigrams; Benton Visual Retention Test 5th Edition, Boston Naming Test, Buschke-Fuld Selective Reminding Test, Delis Kaplan Executive Function System (DKEFS), Color-Word subtest, DKEFS Tower Test, DKEFS Trail Making Test, DKEFS Verbal Fluency subtest, Purdue Pegboard, Rey-Osterrieth Complex Figure Test, Taylor Complex Figure Task, Wechsler Abbreviated Scale of Intelligence, and the Wechsler Adult Intelligence Scale-3rd Edition.

  2. OGTT [ Time Frame: Change from Baseline to 3 months ]
    Oral Glucose Tolerance Test (OGTT): After an overnight fast, subjects will be given a oral glucose challenge, wherein plasma glucose concentrations will be measured at baseline, T30min, T60min, T90min, and T120min after 75gm oral glucose load. Individuals with fasting glucose of 100-125 mg/dl and/or a 2-hour glucose of 140-199 mg/dL and less than 200 mg/dL will be eligible for study enrollment. OGTT will be repeated at the end of the study.



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects will be men and women between the ages of 50 and 70 yrs of age, with a BMI of 27 to 37 kg/m2 and at least 12 yrs of education.
  • All subjects will be medically stable (i.e. no uncontrolled or poorly controlled medical illnesses), cognitively-intact as defined by Mini Mental Status Exam (MMSE) score of > 27, and will have adequate visual and auditory acuity to allow for cognitive testing.
  • Metabolic function will be determined as impaired fasting glucose 100-125 mg/dL and/or impaired 2-hr glucose concentration 140-199 and <200mg/dL on 75-g oral glucose challenge.
  • Also, half of all subjects will have a family history of dementia.

Exclusion Criteria:

  • Diagnosis of possible or probable AD, MCI, or any other dementia; evidence of cognitive decline by MMSE score of <27 or self-reported significant decline in memory within the past year (per the Memory Function Questionnaire) (MFQ)
  • History of Type I or Type II diabetes, or fasting plasma glucose > 126 mg/dL
  • History of significant CVD or myocardial infarction; unstable cerebrovascular or pulmonary disease, gallstones, pancreatitis or cancer, multiple endocrine neoplasia (MEN) untreated hypothyroidism, unstable or untreated hypertension, anemia as determined by hematocrit < 30%
  • Abnormal renal clearance as determined by the serum creatinine ³ 1.5 mg/d, hepatic dysfunction as determined by ALT > 2 times the upper limit of normal
  • Presence of medications known to affect insulin action or insulin secretion
  • Premature birth (which may affect MRI findings), history of neurological disorder (ischemic attacks, carotid bruits, or lacunes upon MRI scan), or evidence of neurologic or other physical illness that could produce cognitive deterioration; use of any drug that may significantly affect the OGTT results or cognitive testing results (specifically: cs)
  • Drug or alcohol abuse or dependence within the past 6 months, positive urine toxicology screen for illicit substances at eligibility screening, history of mental illness, with the exception of past mood disorder, or evidence of acute depression as determined by a 17-item Hamilton Depression Rating Scale (HDRS-17) score of 8 or more.
  • Participants with history of mood disorder must be in remission for at least 6 months prior to study entry.

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): NCT02140983


Locations
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United States, California
Stanford Department of Psychiatry
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
American Diabetes Association
Investigators
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Principal Investigator: Natalie Rasgon, M.D., Ph.D. Stanford University

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Responsible Party: Natalie Rasgon, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02140983    
Other Study ID Numbers: 25076
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Keywords provided by Natalie Rasgon, Stanford University:
Insulin Resistance
Family History of Dementia
Cognition
Additional relevant MeSH terms:
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Dementia
Insulin Resistance
Prediabetic State
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists