Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- OGTT (oral glucose tolerance test)
研究概览
简要总结
This study will be investigating the effect of latent tuberculosis infection (LTBI) treatment on glucose tolerance and low-grade inflammation. Almost a century ago, researchers proposed that diabetes (DM) was associated with increased risk of Tuberculosis infection (TB). A more recent systematic review concluded that DM increases the relative risk for TB 3.1 times. Reversely, TB may affect the glycaemic control; TB is in many cases a chronic infection characterised by long term low-grade inflammation and weight loss, and persons with TB are known to be at risk of hyperglycaemia and DM at time of diagnosis. A latent infection with the m.tuberculosis bacteria is "silent" without symptoms.
1,7 billion have LTBI on a global scale. Event though the infected person does not experience symptoms, increased background inflammation has been shown in LTBI patients in previous studies. We also know that an increase in inflammatory markers precedes clinical development of DM, and that subclinical inflammation contributes to insulin resistance. We hypothesise that LTBI contributes to dysregulated glucose metabolism due to increased low-grade inflammation, and that treatment will reduce low-grade inflammation and improve glucose tolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Inclusion criteria for the LTBIDM arm:
- •18+ years
- •Known DM type 2
- •Inclusion criteria for LTBI arm
- •18+ years
- •LTBI positive
- •No diagnosis with or known DM (1 and 2)
- •Exclusion Criteria (both arms) :
- •Previous treatment for TB or LTBI
- •Pregnancy
- •Type 1 DM
- •Known immunosuppression such as: HIV, steroid treatment within 14 days before inclusion, daily NSAID treatment, ongoing chemotherapy, ongoing immunomodulating treatment or splenectomy
- •Known contraindication to both study drugs
- •Known active liver disease
- •Known severe inflammatory or rheumatological diseases with immune activation and need for prolonged systemic treatment such as IBD, RA, Psoriasis and Wegners granulomatosis
- •Recent antibiotic treatment (>2 days) or severe infection within 14 days before enrollment
- •Known active cancer
排除标准
- 未提供
研究组 & 干预措施
LTBI and DM
Participants with LTBI and DM will be treated with Rifampicin or Isoniazid at the treating physicians discretion
干预措施: Rifampicin 300 Mg Oral Capsule (Drug)
LTBI and DM
Participants with LTBI and DM will be treated with Rifampicin or Isoniazid at the treating physicians discretion
干预措施: Isoniazid 300 Mg ORAL TABLET (Drug)
LTBI without DM
Participants with LTBI without DM will be treated with Rifampicin or Isoniazid at the treating physicians discretion
干预措施: Rifampicin 300 Mg Oral Capsule (Drug)
LTBI without DM
Participants with LTBI without DM will be treated with Rifampicin or Isoniazid at the treating physicians discretion
干预措施: Isoniazid 300 Mg ORAL TABLET (Drug)
结局指标
主要结局
OGTT (oral glucose tolerance test)
时间窗: Time Frame: 4-6 months (depending on treatment)
Reduction in plasma glucose area under the curve during OGTT
次要结局
- Changes in insulin resistance(Time Frame: 4-6 months (depending on treatment))
- Changes in low-grade inflammatory markers and in adipokines(Time Frame: 4-6 months (depending on treatment))
- INF-gamma change(Time Frame: 4-6 months (depending on treatment))
- Changes in body composition(Time Frame: 4-6 months (depending on treatment))
- Changes in insulin production(Time Frame: 4-6 months (depending on treatment))
研究者
Niklas Lorentsson
MD
Herlev and Gentofte Hospital