An interventional study of Sodium butyrate in Diabetes Mellitus, Type 1 and Albuminuria, sponsored by Steno Diabetes Center Copenhagen. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-03.
Sponsored by Steno Diabetes Center Copenhagen · Not applicable, Interventional, and Treatment
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.
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.
121 studies on the registry are indexed under Albuminuria; 21 are open to participants now.
This study's planned enrollment of 48 is below the median of 73 across 96 interventional studies indexed under Albuminuria.
Browse Albuminuria studies →Steno Diabetes Center Copenhagen is the lead sponsor of 111 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
3.6 g sodium butyrate. 6 capsules twice daily for 12 weeks.
Dietary Supplement: Sodium butyrate
Placebo. 6 capsules twice daily for 12 weeks.
Dietary Supplement: Sodium butyrate
Sodium butyrate Class: Fatty acids Ingredients (100 g): Na-butyrate (50 g), acylglycerol (mono- di, -triacylglycerol; 42 g), bee wax (5 g), sodium alginate E401 (2 g), emulsifier (0.5 g). The capsules contain granulated sodium butyrate and are coated with a sodium alginate membrane.
Intestinal inflammation
Change in concentration of fecal calprotectin determined by ELISA
Time frame: Baseline to week 12
Fecal intestinal alkaline phosphatase (IAP)
Change in IAP activity in feces assessed by colorimetric assay
Time frame: Baseline to week 12
Short-chain fatty acids (SCFAs)
Change in acetate, propionate, butyrate and valerate concentration in feces measured by gas chromatography-mass spectrometry
Time frame: Baseline to week 12
Albuminuria
Change in urinary albumin-creatinine ratio (UACR)
Time frame: Baseline to week 12
Kidney function
Change in eGFR
Time frame: Baseline to week 12
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Steno Diabetes Center Copenhagen