Liraglutide for HIV-associated Neurocognitive Disorder
- Conditions
- HIV InfectionDiabetes Mellitus Type 2Metabolic SyndromeObesityOverweight
- Interventions
- Registration Number
- NCT02743598
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Liraglutide Liraglutide -
- Primary Outcome Measures
Name Time Method Neurocognitive performance- change in global cognitive scores on a standard neuropsychological profile 6 months Neurocognitive performance- change in domain averages on a standard neuropsychological profile 6 months
- Secondary Outcome Measures
Name Time Method Change from baseline Interleukin 6 3 and 6 months Number of subjects with Adverse events 3 and 6 months Change from baseline high sensitivity C-reactive protein 3 and 6 months Change from baseline d-dimer 3 and 6 months Change from baseline plasma soluble cluster of differentiation 14 (CD14) 3 and 6 months Change from baseline weight 3 and 6 months Change from baseline blood pressure 3 and 6 months Change from baseline liver enzymes aspartate aminotransferase and alanine aminotransferase 3 and 6 months Change from baseline fructosamine 3 and 6 months Change from baseline Hemoglobin A1c 3 and 6 months Change from baseline BMI 3 and 6 months Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR) in subjects not on insulin 3 and 6 months Change from baseline serum LDL 3 and 6 months Change from baseline waist circumference 3 and 6 months Change from baseline serum triglycerides 3 and 6 months Number of Adverse events 3 and 6 months
Trial Locations
- Locations (1)
Cherie Vaz
🇺🇸Philadelphia, Pennsylvania, United States