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Effect of Butyrate on Inflammation and Albuminuria in Patients With Albuminuria, Type 1 Diabetes and Intestinal Inflammation

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ClinicalTrials.gov Identifier: NCT04073927
Recruitment Status : Recruiting
First Posted : August 29, 2019
Last Update Posted : September 2, 2019
Sponsor:
Collaborator:
Folkhälsan Researech Center
Information provided by (Responsible Party):
Peter Rossing, Steno Diabetes Center Copenhagen

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Albuminuria Dietary Supplement: Sodium butyrate Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : August 5, 2020
Estimated Study Completion Date : August 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: Sodium butyrate
3.6 g sodium butyrate. 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.


Placebo Comparator: Placebo
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.





Primary Outcome Measures :
  1. Intestinal inflammation [ Time Frame: Baseline to week 12 ]
    Change in concentration of fecal calprotectin determined by ELISA


Secondary Outcome Measures :
  1. Fecal intestinal alkaline phosphatase (IAP) [ Time Frame: Baseline to week 12 ]
    Change in IAP activity in feces assessed by colorimetric assay

  2. Short-chain fatty acids (SCFAs) [ Time Frame: Baseline to week 12 ]
    Change in acetate, propionate, butyrate and valerate concentration in feces measured by gas chromatography-mass spectrometry

  3. Albuminuria [ Time Frame: Baseline to week 12 ]
    Change in urinary albumin-creatinine ratio (UACR)

  4. Kidney function [ Time Frame: Baseline to week 12 ]
    Change in eGFR



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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)
  2. Albuminuria: UACR > 30 mg/g documented in medical history
  3. Calprotectin quick-test result ≥ 50 μg/g (CalDetect 50/200, Preventis) between visit 1 and visit 2.
  4. Able to understand the written patient information and give informed consent

Exclusion Criteria:

  1. Known inflammatory bowel disease
  2. IBD symptoms due to investigators opinion
  3. Known celiac disease
  4. Existing ostomy
  5. Known rheumatic disorders treated with anti-inflammatory agents
  6. Known hyperthyroidism or hypothyroidism Butyful Protocol - page 12 - Version 3, 25.02.2019
  7. Active immunosuppressant therapy with systemic effect due to investigator's opinion
  8. Current cancer treatment or within five years from baseline (except basal cell skin cancer or squamous cell skin cancer)
  9. eGFR<15, dialysis or kidney transplantation
  10. Diagnosis of non-diabetic CKD
  11. Active antibiotic therapy until 30 days ahead of screening
  12. Unable to participate in study procedures
  13. Not able to assess calprotectin by quick test in two attempts
  14. 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
  15. Pregnancy or lactation
  16. Participation in another intervention study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073927


Contacts
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Contact: Peter Rossing, Professor +45 30193383 peter.rossing@regionh.dk
Contact: Ninna Hahn Tougaard, MD +45 29399798 ninna.hahn.tougaard.01@regionh.dk

Locations
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Denmark
Steno Diabetes Center Copenhagen Recruiting
Gentofte, Denmark, 2820
Contact: Peter Rossing, Professor    +45 30193383    peter.rossing@regionh.dk   
Finland
Folkhälsan Research Center, FinnDiane Not yet recruiting
Helsinki, Finland, FIN-00290
Contact: Markku Lehto    +358-40-7715484    markku.lehto@helsinki.fi   
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Folkhälsan Researech Center
Investigators
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Principal Investigator: Peter Rossing, Professor Steno Diabetes Center Copenhagen

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Responsible Party: Peter Rossing, Professor, MD, DMsc, Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT04073927     History of Changes
Other Study ID Numbers: H-18062027
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Albuminuria
Inflammation
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Autoimmune Diseases
Immune System Diseases
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Butyric Acid
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs