Metformin Administration Effect Over Systemic Inflammation Serum Markers in HIV Positive Prediabetic Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Quantification of proinflammatory cytokines serum levels by Cytometric Bead Array in prediabetic HIV positive patients after 8 weeks treatment with Metformin
研究概览
简要总结
The purposes of this study are to find out if: metformin can be combined with anti-HIV drugs to reduce systemic inflammation measured by the determination of cytokines and other series of serum markers. To determine if the concomitant administration of metformin with TARA improves the immune function on the CD4 T cell count and its relation with the CD8 T cells, during the treatment and after its interruption.
To this end, in the present study, patients with prediabetes (who meet the fasting impaired glucose criteria) will be identified and treated with metformin or placebo for 8 weeks, receiving stable TARA and with a CD4 + level> 200 cells / μL.
40 patients from the HIV Unit of the Civil Hospital of Guadalajara "Fray Antonio Alcalde" will be included in this study and the intervention will last 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes,
- •Age ≥18 years of age
- •With a diagnosis of HIV-1 infection,
- •That they are receiving TARE for at least 12 months (time necessary to establish a stable reservoir),
- •Patients with undetectable viral load (<40 copies / mL) for at least 12 months,
- •Have a CD4 + level> 200 cells / μL,
- •That they do not have a diagnosis of co-infection with HCV or HBV,
- •Patients who do not have a severe alcohol intake (<21 glasses / week in men and <14 glasses / week in women),
- •Patients who do not use drugs during the last 90 days prior to the screening visit, or during the study,
- •Who wish to participate voluntarily in the study and give their written consent.
排除标准
- •Individuals with a known hypersensitivity / allergy to metformin.
- •Patients with contraindications to the use of metformin *.
- •Individuals who are actively involved in an experimental therapy study or who have received experimental therapy in the last 6 months.
- •People suffering from stage IV-V chronic kidney disease, uncontrolled heart failure or active infections.
- •Individuals with diabetes mellitus (according to the criteria of the American Diabetes Association *).
- •Patients with indication for the use of statins, aspirin or immunomodulators.
研究组 & 干预措施
Metformin Experimental Arm
Metformin 850mg/12 hours, oral, 8 weeks
干预措施: Metformin Hydrochloride 850 MG (Drug)
Placebo Comparator Arm
Placebo pills/12hours, oral, 8 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Quantification of proinflammatory cytokines serum levels by Cytometric Bead Array in prediabetic HIV positive patients after 8 weeks treatment with Metformin
时间窗: Basal - 8 weeks
Serum levels of proinflammatory cytokines will be quantify by flow cytometry using a Cytometric Bead Array. The cytokine panel to be messured will be as follows: * IL-1beta * IFN-alpha2 * IFN-gamma * TNF-alpha * MCP-1 * IL-6 * IL-8 * IL-10 * IL-12p70 * IL-17A * IL-18 * IL-23 * IL-33 These cytokines will be quantify in prediabetic HIV positive patients after 8 weeks treatment with Metformin
次要结局
未报告次要终点
研究者
Moises Ramos Solano
Associate professor
Hospital Civil de Guadalajara