Effects of Liraglutide on Cognition, Chronic Inflammation and Glycemic Control in Overweight and Obese, HIV-infected Subjects With Type 2 Diabetes.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Neurocognitive performance- change in global cognitive scores on a standard neuropsychological profile
研究概览
简要总结
This study will test the effect of liraglutide on cognitive function in HIV-infected overweight or obese subjects with type 2 diabetes.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Liraglutide
干预措施: Liraglutide (Drug)
结局指标
主要结局
Neurocognitive performance- change in global cognitive scores on a standard neuropsychological profile
时间窗: 6 months
Neurocognitive performance- change in domain averages on a standard neuropsychological profile
时间窗: 6 months
次要结局
- Change from baseline serum triglycerides(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 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 Interleukin 6(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)