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

NCT04073927 | Unknown DMC

• 1 other identifier: H-18062027
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 1; Albuminuria

Outcome Measures

Primary Outcomes (1)

• Intestinal inflammation

  Change in concentration of fecal calprotectin determined by ELISA

  Baseline to week 12

Secondary Outcomes (4)

• Fecal intestinal alkaline phosphatase (IAP)

  Baseline to week 12

• Short-chain fatty acids (SCFAs)

  Baseline to week 12

• Albuminuria

  Baseline to week 12

• Kidney function

  Baseline to week 12

Study Arms (2)

Sodium butyrate

ACTIVE COMPARATOR

3.6 g sodium butyrate. 6 capsules twice daily for 12 weeks.

Dietary Supplement: Sodium butyrate

Placebo

PLACEBO COMPARATOR

Placebo. 6 capsules twice daily for 12 weeks.

Dietary Supplement: Sodium butyrate

Interventions

Sodium butyrate DIETARY_SUPPLEMENT

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; Sodium butyrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Folkhälsan Researech Center: collaborator

Study Sites (2)

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

RECRUITING

Folkhälsan Research Center, FinnDiane

Helsinki, FIN-00290, Finland

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Albuminuria

Interventions

Butyric Acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Proteinuria; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Peter Rossing, Professor

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Rossing, Professor

CONTACT

+45 30193383; peter.rossing@regionh.dk

Ninna Hahn Tougaard, MD

CONTACT

+45 29399798; ninna.hahn.tougaard.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, DMsc

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 29, 2019
• Study Start: August 5, 2019
• Primary Completion: August 5, 2020
• Study Completion: August 5, 2020
• Last Updated: September 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); FI (1)