The Butyful Study. Effect of Butyrate on Inflammation and Albuminuria in Patients With Albuminuria, Type 1 Diabetes and Intestinal Inflammation A Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Intestinal inflammation
研究概览
简要总结
The objective is to assess the impact of 12 weeks supplement of sodium-butyrate twice daily or placebo on intestinal inflammation and albuminuria.
A randomized, placebo-controlled, double-blind, two-site trial including 48 patients with type 1 diabetes, albuminuria and intestinal inflammation. Participants will be randomized 1:1 to active treatment or placebo for a period of 12 weeks.
The primary endpoint is change from baseline to week 12 in intestinal inflammation, measured by fecal calprotectin.
详细描述
In patients with type 1 diabetes, increased intestinal inflammation, reduced gut barrier function and resulting influx of proinflammatory molecules have been described. This might contribute to systemic inflammation and the development of diabetic complications like nephropathy and ischemic heart disease. Interestingly, the gut microbiota is altered in persons with type 1 diabetes, who have less butyrate-producing bacteria. The short-chain fatty acid butyrate improves the intestinal barrier function, and the altered bacterial composition is hypothesized to play a role in the intestinal inflammation. Treatment with butyrate has improved metabolic, colonic and renal function in animal models of chronic kidney disease.
The aim of the study is to test whether orally ingested sodium butyrate can reduce intestinal inflammation in patients with type 1 diabetes and albuminuria in a randomized, placebo-controlled, double-blind, two-site trial.
Persons with type 1 diabetes and albuminuria are recruited from Steno Diabetes Center Copenhagen (SDCC) and Folkhälsan Research Center, FinnDiane, Helsinki, Finland and screened for intestinal inflammation. 48 participants with intestinal inflammation (fecal calprotectin ≥50 μg/g) are randomized to receive 3.6 g sodium butyrate or placebo for 12 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female patients ≥ 18 years of age with a diagnosis of type 1 diabetes (age at onset <40 years; permanent insulin treatment initiated within 1 year of diagnosis)
- •Albuminuria: UACR > 30 mg/g documented in medical history
- •Calprotectin quick-test result ≥ 50 μg/g (CalDetect 50/200, Preventis) between visit 1 and visit
- •Able to understand the written patient information and give informed consent
排除标准
- •Known inflammatory bowel disease
- •IBD symptoms due to investigators opinion
- •Known celiac disease
- •Existing ostomy
- •Known rheumatic disorders treated with anti-inflammatory agents
- •Known hyperthyroidism or hypothyroidism Butyful Protocol - page 12 - Version 3, 25.02.2019
- •Active immunosuppressant therapy with systemic effect due to investigator's opinion
- •Current cancer treatment or within five years from baseline (except basal cell skin cancer or squamous cell skin cancer)
- •eGFR<15, dialysis or kidney transplantation
- •Diagnosis of non-diabetic CKD
- •Active antibiotic therapy until 30 days ahead of screening
- •Unable to participate in study procedures
- •Not able to assess calprotectin by quick test in two attempts
- •Any clinically significant disorder, except for conditions associated with type 1 DM history, which in the Investigators opinion could interfere with the results of the trial
- •Pregnancy or lactation
- •Participation in another intervention study
研究组 & 干预措施
Sodium butyrate
3.6 g sodium butyrate. 6 capsules twice daily for 12 weeks.
干预措施: Sodium butyrate (Dietary Supplement)
Placebo
Placebo. 6 capsules twice daily for 12 weeks.
干预措施: Sodium butyrate (Dietary Supplement)
结局指标
主要结局
Intestinal inflammation
时间窗: Baseline to week 12
Change in concentration of fecal calprotectin determined by ELISA
次要结局
- Kidney function(Baseline to week 12)
- Fecal intestinal alkaline phosphatase (IAP)(Baseline to week 12)
- Short-chain fatty acids (SCFAs)(Baseline to week 12)
- Albuminuria(Baseline to week 12)
研究者
Peter Rossing
Professor, MD, DMsc
Steno Diabetes Center Copenhagen