Abstract
Type 1 diabetes is associated with increased intestinal inflammation and decreased abundance of butyrate-producing bacteria. We investigated the effect of butyrate on inflammation, kidney parameters, HbA1c, serum metabolites and gastrointestinal symptoms in persons with type 1 diabetes, albuminuria and intestinal inflammation. We conducted a randomized placebo-controlled, double-blind, parallel clinical study involving 53 participants randomized to 3.6 g sodium butyrate daily or placebo for 12 weeks. The primary endpoint was the change in fecal calprotectin. Additional endpoints were the change in fecal short chain fatty acids, intestinal alkaline phosphatase activity and immunoglobulins, serum lipopolysaccharide, CRP, albuminuria, kidney function, HbA1c, metabolites and gastrointestinal symptoms. The mean age was 54 ± 13 years, and the median [Q1:Q3] urinary albumin excretion was 46 [14:121] mg/g. The median fecal calprotectin in the butyrate group was 48 [26:100] μg/g at baseline, and the change was −1.0 [−20:10] μg/g; the median in the placebo group was 61 [25:139] μg/g at baseline, and the change was −12 [−95:1] μg/g. The difference between the groups was not significant (p = 0.24); neither did we find an effect of butyrate compared to placebo on the other inflammatory markers, kidney parameters, HbA1c, metabolites nor gastrointestinal symptoms. Twelve weeks of butyrate supplementation did not reduce intestinal inflammation in persons with type 1 diabetes, albuminuria and intestinal inflammation.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 3573 |
| Tidsskrift | Journal of Clinical Medicine |
| Vol/bind | 11 |
| Udgave nummer | 13 |
| ISSN | 2077-0383 |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:Funding: The Novo Nordisk Foundation: PROTON: PeRsOnalizing Treatment Of diabetic Nephropathy (grant number NNFOC0013659).
Funding Information:
Conflicts of Interest: M.F.-M. reports having received research grants from Novo Nordisk and speaking fees from Boehringer Ingelheim, Novartis, Baxter and Sanofi. T.W.H. has shares in Novo Nordisk A/S. P.H.G. is an advisory board member of AbbVie, Astellas, Astra Zeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Janssen, Medscape, MSD, Mundipharma, Nestlé, Novartis, Novo Nordisk and Sanofi, and has received lecture honoraria from Astellas, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Elo Water, Genzyme, Medscape, MSD, Mundipharma, Novartis, Novo Nordisk, Sanofi and SCIARC. P.R. has received research support and personal fees from AstraZeneca and Novo Nordisk, and personal fees from Astellas, Boehringer Ingelheim, Eli Lilly, Gilead, Mundipharma, Sanofi, and Vifor; all fees are given to the Steno Diabetes Center Copenhagen. N.H.T., H.S., E.B.S., A.D.Z., I.M.M., C.L.Q., S.H., C.F. and M.L. have no conflicts of interest.
Funding Information:
The Novo Nordisk Foundation: PROTON: PeRsOnalizing Treatment Of diabetic Nephropathy (grant number NNFOC0013659).Acknowledgments: We thank the participants and laboratory technicians (Dorthe Riis, Tina Ragnholm Juhl, Jessie Armand Hermann, Tina Nielsen and Maja Lis Dybdahl Halkjær) from Steno Diabetes Center Copenhagen, Denmark; the participants, study nurses (Anna Sandelin, Mira Korolainen and Jaana Tuomikangas) and laboratory technicians (Hanna Olanne and Heli Krigsman) from Folkhälsan Research Center Helsinki, Finland; and Sirpa Rannikko from University of Oulu, Finland for technical assistance.
Publisher Copyright:
© 2022 by the authors. Licensee MDPI, Basel, Switzerland.