Back to resultsEffect of Butyrate on Inflammation and Albuminuria in Patients With Albuminuria, Type 1 Diabetes and Intestinal Inflammation
Primary Purpose
Diabetes Mellitus, Type 1, Albuminuria
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Sodium butyrate
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- 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 2.
- Able to understand the written patient information and give informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Steno Diabetes Center CopenhagenRecruiting
- Folkhälsan Research Center, FinnDiane
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Sodium butyrate
Placebo
Arm Description
3.6 g sodium butyrate. 6 capsules twice daily for 12 weeks.
Placebo. 6 capsules twice daily for 12 weeks.
Outcomes
Primary Outcome Measures
Intestinal inflammation
Change in concentration of fecal calprotectin determined by ELISA
Secondary Outcome Measures
Fecal intestinal alkaline phosphatase (IAP)
Change in IAP activity in feces assessed by colorimetric assay
Short-chain fatty acids (SCFAs)
Change in acetate, propionate, butyrate and valerate concentration in feces measured by gas chromatography-mass spectrometry
Albuminuria
Change in urinary albumin-creatinine ratio (UACR)
Kidney function
Change in eGFR
Full Information
NCT ID
NCT04073927
First Posted
August 16, 2019
Last Updated
August 29, 2019
Sponsor
Steno Diabetes Center Copenhagen
Collaborators
Folkhälsan Researech Center
1. Study Identification
Unique Protocol Identification Number
NCT04073927
Brief Title
Effect of Butyrate on Inflammation and Albuminuria in Patients With Albuminuria, Type 1 Diabetes and Intestinal Inflammation
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
August 5, 2020 (Anticipated)
Study Completion Date
August 5, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Steno Diabetes Center Copenhagen
Collaborators
Folkhälsan Researech Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Albuminuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sodium butyrate
Arm Type
Active Comparator
Arm Description
3.6 g sodium butyrate. 6 capsules twice daily for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo. 6 capsules twice daily for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Sodium butyrate
Intervention Description
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 Measure Information:
Title
Intestinal inflammation
Description
Change in concentration of fecal calprotectin determined by ELISA
Time Frame
Baseline to week 12
Secondary Outcome Measure Information:
Title
Fecal intestinal alkaline phosphatase (IAP)
Description
Change in IAP activity in feces assessed by colorimetric assay
Time Frame
Baseline to week 12
Title
Short-chain fatty acids (SCFAs)
Description
Change in acetate, propionate, butyrate and valerate concentration in feces measured by gas chromatography-mass spectrometry
Time Frame
Baseline to week 12
Title
Albuminuria
Description
Change in urinary albumin-creatinine ratio (UACR)
Time Frame
Baseline to week 12
Title
Kidney function
Description
Change in eGFR
Time Frame
Baseline to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 2.
Able to understand the written patient information and give informed consent
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Rossing, Professor
Phone
+45 30193383
Email
peter.rossing@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Ninna Hahn Tougaard, MD
Phone
+45 29399798
Email
ninna.hahn.tougaard.01@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Rossing, Professor
Organizational Affiliation
Steno Diabetes Center Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steno Diabetes Center Copenhagen
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Rossing, Professor
Phone
+45 30193383
Email
peter.rossing@regionh.dk
Facility Name
Folkhälsan Research Center, FinnDiane
City
Helsinki
ZIP/Postal Code
FIN-00290
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markku Lehto
Phone
+358-40-7715484
Email
markku.lehto@helsinki.fi
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Butyrate on Inflammation and Albuminuria in Patients With Albuminuria, Type 1 Diabetes and Intestinal Inflammation
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