Diabetes Mellitus, Type 1NCT04073927
Effect of Butyrate on Inflammation and Albuminuria in Patients With Albuminuria, Type 1 Diabetes and Intestinal Inflammation
A study testing Sodium butyrate in people with Diabetes Mellitus, Type 1 and Albuminuria, run by Steno Diabetes Center Copenhagen at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Albuminuria
- What is being tested?
- Sodium butyrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Aug 2019to 5 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Denmark1 site, 1 recruiting
- Recruiting
Steno Diabetes Center Copenhagen
Gentofte Municipality, 2820
Peter Rossing, Professor, +45 30193383, peter.rossing@regionh.dk
Finland1 site, 1 recruiting
- Not yet recruiting
Folkhälsan Research Center, FinnDiane
Helsinki, FIN-00290
Markku Lehto, +358-40-7715484, markku.lehto@helsinki.fi
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1, Albuminuria
- Being tested
- Sodium butyrate
- Medical subject headings
- Diabetes Mellitus, Type 1, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium butyrateDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Sodium butyrate | Active comparator | 3.6 g sodium butyrate. 6 capsules twice daily for 12 weeks. Receives: Dietary Supplement: Sodium butyrate |
| Placebo | Placebo comparator | Placebo. 6 capsules twice daily for 12 weeks. Receives: Dietary Supplement: Sodium butyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal inflammation
Change in concentration of fecal calprotectin determined by ELISA
Measured: Baseline to week 12
Secondary outcomes (4)
Fecal intestinal alkaline phosphatase (IAP)
Change in IAP activity in feces assessed by colorimetric assay
Measured: Baseline to week 12
Short-chain fatty acids (SCFAs)
Change in acetate, propionate, butyrate and valerate concentration in feces measured by gas chromatography-mass spectrometry
Measured: Baseline to week 12
Albuminuria
Change in urinary albumin-creatinine ratio (UACR)
Measured: Baseline to week 12
Kidney function
Change in eGFR
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start5 Aug 2019
- Primary completion5 Aug 2020 (estimated)
- Study completion5 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Folkhälsan Researech Center
- Responsible party
- Principal investigator, Peter Rossing, Steno Diabetes Center Copenhagen
- Investigators
- Peter Rossing, Professor, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073927
- Sponsor's protocol ID
- H-18062027
- Status last verified
- Aug 2019
- First submitted
- 16 Aug 2019
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04073927
- Acronym / sponsor ID
- H-18062027
- Conditions
- Diabetes Mellitus, Type 1, Albuminuria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Folkhälsan Researech Center
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 5 Aug 2020 (estimated)
- Study completion
- 5 Aug 2020 (estimated)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium butyrate | Active comparator | Dietary Supplement: Sodium butyrate3.6 g sodium butyrate. 6 capsules twice daily for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Sodium butyratePlacebo. 6 capsules twice daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- Known inflammatory bowel disease
- IBD symptoms due to investigators opinion
- Known celiac disease
- Existing ostomy
- Known rheumatic disorders treated with anti-inflammatory agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium butyrateSodium 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. | Dietary supplement | Placebo, Sodium butyrate |
Primary outcome
Intestinal inflammation
Time frame: Baseline to week 12
Change in concentration of fecal calprotectin determined by ELISA
4 secondary outcomes
Fecal intestinal alkaline phosphatase (IAP)
Time frame: Baseline to week 12
Short-chain fatty acids (SCFAs)
Time frame: Baseline to week 12
Albuminuria
Time frame: Baseline to week 12
Kidney function
Time frame: Baseline to week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Rossing, Professor principal investigator
Steno Diabetes Center Copenhagen
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium butyrate in people with Diabetes Mellitus, Type 1 and Albuminuria, run by Steno Diabetes Center Copenhagen at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Rossing, Professor (+45 30193383, peter.rossing@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal inflammation (time frame: Baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.