Scholarlink

Objective <p>To study the effect of two doses of BCG vaccination on immune-regulatory markers and glycemic control in patients with type 1 diabetes (T1DM).</p> Methods <p>In this single-centre, double-blinded, randomised, placebo-controlled pilot trial, children with new-onset T1DM (diagnosed within the last 6&#xa0;months) were included and were randomised 1:1 into BCG and placebo groups, with 20 children in each group. Two doses of 0.1-mL BCG vaccine or 0.1&#xa0;mL of normal saline was administered intradermally 1&#xa0;month apart in the BCG group and placebo group, respectively. The primary outcome parameters included changes in regulatory T cell (T-regs) percentage, changes in pancreatic autoantibody titres and serum IL-10, IL-17, and TNF-alpha cytokine levels. The secondary outcome parameters included changes in various glycemic control parameters.</p> Results <p>At the end of 6&#xa0;months, no significant differences were observed in Treg percentages, cytokine levels, and autoantibody titres between the BCG and placebo groups. We observed a reduction of HbA1c (<i>p</i> = 0.421) and a lesser fall of C-peptide (<i>p</i> = 0.496) values in the BCG group. The mean fasting, random blood sugar, and median total/basal/bolus insulin dose did not vary significantly between the two groups at 6&#xa0;months.</p> Conclusion <p>BCG administration did not significantly improve immune-regulatory markers and glycemic control parameters among children with new-onset T1DM who have been vaccinated at birth. However, there was a trend towards improvement of glycemic parameters in BCG group.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Effect of BCG vaccination on immune-regulatory markers and glycemic control in children with new-onset type 1 diabetes mellitus (T1DM): A randomised double-blinded placebo-controlled pilot trial

  • 期刊论文

  • 发表日期：

    2025年5月2日

查看全文
  • Alisha Babbar,
  • Rakesh Kumar,
  • Neenu Jacob,
  • Amit Rawat,
  • Naresh Sachdeva,
  • Bhavneet Bharti,
  • Saniya Gupta,
  • Jaivinder Yadav

摘要

Objective

To study the effect of two doses of BCG vaccination on immune-regulatory markers and glycemic control in patients with type 1 diabetes (T1DM).

Methods

In this single-centre, double-blinded, randomised, placebo-controlled pilot trial, children with new-onset T1DM (diagnosed within the last 6 months) were included and were randomised 1:1 into BCG and placebo groups, with 20 children in each group. Two doses of 0.1-mL BCG vaccine or 0.1 mL of normal saline was administered intradermally 1 month apart in the BCG group and placebo group, respectively. The primary outcome parameters included changes in regulatory T cell (T-regs) percentage, changes in pancreatic autoantibody titres and serum IL-10, IL-17, and TNF-alpha cytokine levels. The secondary outcome parameters included changes in various glycemic control parameters.

Results

At the end of 6 months, no significant differences were observed in Treg percentages, cytokine levels, and autoantibody titres between the BCG and placebo groups. We observed a reduction of HbA1c (p = 0.421) and a lesser fall of C-peptide (p = 0.496) values in the BCG group. The mean fasting, random blood sugar, and median total/basal/bolus insulin dose did not vary significantly between the two groups at 6 months.

Conclusion

BCG administration did not significantly improve immune-regulatory markers and glycemic control parameters among children with new-onset T1DM who have been vaccinated at birth. However, there was a trend towards improvement of glycemic parameters in BCG group.