Clinical trial NCT02743598: Liraglutide for HIV-associated Neurocognitive Disorder
Official title: Effects of Liraglutide on Cognition, Chronic Inflammation and Glycemic Control in Overweight and Obese, HIV-infected Subjects With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV Infection
Diabetes Mellitus Type 2
Obesity
Overweight
Metabolic Syndrome
Keywords: HIV infection
Diabetes Mellitus type 2
Obesity
Neurocognitive function
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: The Comprehensive NeuroAIDS Center (CNAC) at Temple University
First posted: 2016-04-19
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Neurocognitive performance- change in global cognitive scores on a standard neuropsychological profile
timeFrame: 6 months
measure: Neurocognitive performance- change in domain averages on a standard neuropsychological profile
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline high sensitivity C-reactive protein
timeFrame: 3 and 6 months
measure: Change from baseline d-dimer
timeFrame: 3 and 6 months
measure: Change from baseline Interleukin 6
timeFrame: 3 and 6 months
measure: Change from baseline plasma soluble cluster of differentiation 14 (CD14)
timeFrame: 3 and 6 months
measure: Change from baseline BMI
timeFrame: 3 and 6 months
measure: Change from baseline weight
timeFrame: 3 and 6 months
measure: Change from baseline waist circumference
timeFrame: 3 and 6 months
measure: Change from baseline blood pressure
timeFrame: 3 and 6 months
measure: Change from baseline serum triglycerides
timeFrame: 3 and 6 months
measure: Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR) in subjects not on insulin
timeFrame: 3 and 6 months
measure: Change from baseline liver enzymes aspartate aminotransferase and alanine aminotransferase
timeFrame: 3 and 6 months
measure: Change from baseline Hemoglobin A1c
timeFrame: 3 and 6 months
measure: Change from baseline fructosamine
timeFrame: 3 and 6 months
measure: Number of Adverse events
timeFrame: 3 and 6 months
measure: Number of subjects with Adverse events
timeFrame: 3 and 6 months
measure: Change from baseline serum LDL
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Cherie Vaz
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Cherie Vaz, MD Dipl ABOM
role: PRINCIPAL_INVESTIGATOR
References: