Liraglutide for HIV-associated Neurocognitive Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, HIV / AIDS, Endocrine, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 9/20/2018 |
| Start Date: | September 2016 |
| End Date: | May 2019 |
| Contact: | Cherie Vaz, MD Dipl ABOM |
| Email: | cherie.vaz@tuhs.temple.edu |
| Phone: | 2157074600 |
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.
overweight or obese subjects with type 2 diabetes.
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.
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.
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
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