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Liraglutide for HIV-associated Neurocognitive Disorder

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ClinicalTrials.gov Identifier: NCT02743598
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
The Comprehensive NeuroAIDS Center (CNAC) at Temple University
Information provided by (Responsible Party):
Temple University

Brief Summary:
This study will test the effect of liraglutide on cognitive function in HIV-infected overweight or obese subjects with type 2 diabetes.

Condition or disease Intervention/treatment Phase
HIV Infection Diabetes Mellitus Type 2 Obesity Overweight Metabolic Syndrome Drug: Liraglutide Phase 4

Detailed Description:
HIV, insulin resistance and type 2 diabetes mellitus (DM) are independently associated with cognitive impairment. Considering the synergistic effects of HIV and DM on cognition, these subjects are at increased risk of cognitive impairment. glucagon-like peptide 1 (GLP-1) receptors have wide tissue distribution including the central nervous system. The study hypothesis is that GLP-1 could potentially ameliorate the impairments in cognition in this population. This study will assess the impact of liraglutide on neurocognitive performance and peripheral inflammatory markers. It will also evaluate the effects of liraglutide on glycemic control and metabolic risk factors in HIV infected subjects with type 2 diabetes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Liraglutide on Cognition, Chronic Inflammation and Glycemic Control in Overweight and Obese, HIV-infected Subjects With Type 2 Diabetes.
Study Start Date : September 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Liraglutide Drug: Liraglutide



Primary Outcome Measures :
  1. Neurocognitive performance- change in global cognitive scores on a standard neuropsychological profile [ Time Frame: 6 months ]
  2. Neurocognitive performance- change in domain averages on a standard neuropsychological profile [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change from baseline high sensitivity C-reactive protein [ Time Frame: 3 and 6 months ]
  2. Change from baseline d-dimer [ Time Frame: 3 and 6 months ]
  3. Change from baseline Interleukin 6 [ Time Frame: 3 and 6 months ]
  4. Change from baseline plasma soluble cluster of differentiation 14 (CD14) [ Time Frame: 3 and 6 months ]
  5. Change from baseline BMI [ Time Frame: 3 and 6 months ]
  6. Change from baseline weight [ Time Frame: 3 and 6 months ]
  7. Change from baseline waist circumference [ Time Frame: 3 and 6 months ]
  8. Change from baseline blood pressure [ Time Frame: 3 and 6 months ]
  9. Change from baseline serum triglycerides [ Time Frame: 3 and 6 months ]
  10. Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR) in subjects not on insulin [ Time Frame: 3 and 6 months ]
  11. Change from baseline liver enzymes aspartate aminotransferase and alanine aminotransferase [ Time Frame: 3 and 6 months ]
  12. Change from baseline Hemoglobin A1c [ Time Frame: 3 and 6 months ]
  13. Change from baseline fructosamine [ Time Frame: 3 and 6 months ]
  14. Number of Adverse events [ Time Frame: 3 and 6 months ]
  15. Number of subjects with Adverse events [ Time Frame: 3 and 6 months ]
  16. Change from baseline serum LDL [ Time Frame: 3 and 6 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV controlled on therapy for at least 12 weeks
  • Viral load < 200 copies
  • BMI >27 to 45
  • Diagnosis of DM type 2 with A1-C >7 to 15
  • Participants must be willing to comply with all study related procedures

Exclusion Criteria:

  • Personal or family history of pancreatitis
  • Medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)
  • Gastroparesis
  • Allergy to liraglutide or any of the active ingredients in liraglutide or other GLP-1 analogue
  • Weight loss drugs other than metformin
  • Type 1 diabetes mellitus or diabetic ketoacidosis
  • Known major cognitive deficit dementia, history of head trauma with loss of consciousness >30 min, history of stroke, current central nervous system (CNS) disorder such as seizures or opportunistic CNS infection
  • Renal insufficiency defined as creatinine clearance < 60 mL/min
  • Active opportunistic infections
  • Pregnancy or breastfeeding
  • Unstable cardiovascular disease with hospitalization within 1 year for acute coronary syndrome
  • Decompensated heart failure
  • Substance abuse
  • Active alcohol or opioid substitution therapy
  • Serious or unstable medical or psychological conditions that would compromise the subject's safety for successful participation

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): NCT02743598


Contacts
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Contact: Cherie Vaz, MD Dipl ABOM 2157074600 cherie.vaz@tuhs.temple.edu

Locations
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United States, Pennsylvania
Cherie Vaz Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Cherie Vaz, MD Dipl.ABOM       cherie.vaz@tuhs.temple.edu   
Sponsors and Collaborators
Temple University
The Comprehensive NeuroAIDS Center (CNAC) at Temple University
Investigators
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Principal Investigator: Cherie Vaz, MD Dipl ABOM Temple University

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT02743598     History of Changes
Other Study ID Numbers: 23284
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Temple University:
HIV infection
Diabetes Mellitus type 2
Obesity
Neurocognitive function

Additional relevant MeSH terms:
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Metabolic Syndrome
Body Weight
Diabetes Mellitus
HIV Infections
Overweight
Diabetes Mellitus, Type 2
Neurocognitive Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Mental Disorders
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists