Liraglutide for HIV-associated Neurocognitive Disorder

Effects of Liraglutide on Cognition, Chronic Inflammation and Glycemic Control in Overweight and Obese, HIV-infected Subjects With Type 2 Diabetes.

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

Study Overview

• Status: Terminated
• Conditions: HIV Infection; Obesity; Overweight; Metabolic Syndrome; Diabetes Mellitus Type 2
• Intervention / Treatment: Drug: Liraglutide

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Cherie Vaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liraglutide	Drug: Liraglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Change from baseline high sensitivity C-reactive protein	3 and 6 months
Change from baseline d-dimer	3 and 6 months
Change from baseline Interleukin 6	3 and 6 months
Change from baseline plasma soluble cluster of differentiation 14 (CD14)	3 and 6 months
Change from baseline BMI	3 and 6 months
Change from baseline weight	3 and 6 months
Change from baseline waist circumference	3 and 6 months
Change from baseline blood pressure	3 and 6 months
Change from baseline serum triglycerides	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 liver enzymes aspartate aminotransferase and alanine aminotransferase	3 and 6 months
Change from baseline Hemoglobin A1c	3 and 6 months
Change from baseline fructosamine	3 and 6 months
Number of Adverse events	3 and 6 months
Number of subjects with Adverse events	3 and 6 months
Change from baseline serum LDL	3 and 6 months

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: The Comprehensive NeuroAIDS Center (CNAC) at Temple University
• Investigators: Principal Investigator: Cherie Vaz, MD Dipl ABOM, Temple University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: April 14, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Obesity; Diabetes Mellitus type 2; HIV infection; Neurocognitive function
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Endocrine System Diseases; Body Weight; Insulin Resistance; Hyperinsulinism; HIV Infections; Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Syndrome; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: 23284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No