Liraglutide for HIV-associated Neurocognitive Disorder

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02743598
• Other study ID #: 23284
• Status: Terminated
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: July 2022
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: September 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• HIV Infection
• HIV Infections
• Metabolic Syndrome
• Obesity
• Overweight

Intervention

Drug:
• Liraglutide

Locations

Country	Name	City	State
United States	Cherie Vaz	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	The Comprehensive NeuroAIDS Center (CNAC) at Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive performance- change in global cognitive scores on a standard neuropsychological profile		6 months
Primary	Neurocognitive performance- change in domain averages on a standard neuropsychological profile		6 months
Secondary	Change from baseline high sensitivity C-reactive protein		3 and 6 months
Secondary	Change from baseline d-dimer		3 and 6 months
Secondary	Change from baseline Interleukin 6		3 and 6 months
Secondary	Change from baseline plasma soluble cluster of differentiation 14 (CD14)		3 and 6 months
Secondary	Change from baseline BMI		3 and 6 months
Secondary	Change from baseline weight		3 and 6 months
Secondary	Change from baseline waist circumference		3 and 6 months
Secondary	Change from baseline blood pressure		3 and 6 months
Secondary	Change from baseline serum triglycerides		3 and 6 months
Secondary	Change from baseline insulin resistance by homeostasis model assessment (HOMA-IR) in subjects not on insulin		3 and 6 months
Secondary	Change from baseline liver enzymes aspartate aminotransferase and alanine aminotransferase		3 and 6 months
Secondary	Change from baseline Hemoglobin A1c		3 and 6 months
Secondary	Change from baseline fructosamine		3 and 6 months
Secondary	Number of Adverse events		3 and 6 months
Secondary	Number of subjects with Adverse events		3 and 6 months
Secondary	Change from baseline serum LDL		3 and 6 months