Status:
UNKNOWN
Effect of Butyrate on Inflammation and Albuminuria in Patients With Albuminuria, Type 1 Diabetes and Intestinal Inflammation
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
Folkhälsan Researech Center
Conditions:
Diabetes Mellitus, Type 1
Albuminuria
Eligibility:
All Genders
18+ years
Phase:
NA
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-...
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 system...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 5 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04073927
Start Date
August 5 2019
End Date
August 5 2020
Last Update
September 3 2019
Active Locations (2)
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1
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark, 2820
2
Folkhälsan Research Center, FinnDiane
Helsinki, Finland, FIN-00290