The effect of sodium butyrate on abdominal symptoms and carbohydrate metabolism in patients with type 2 diabetes
| ISRCTN | ISRCTN10844715 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10844715 |
- Submission date
- 08/01/2025
- Registration date
- 31/01/2025
- Last edited
- 21/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
This study aims to determine whether sodium butyrate supplementation affects carbohydrate metabolism and the severity of abdominal symptoms in patients diagnosed with type 2 diabetes.
Who can participate?
Eligible participants include type 2 diabetes patients who report gastrointestinal symptoms (meeting the Rome V criteria for the diagnosis of irritable bowel syndrome), such as abdominal pain, bloating, diarrhea, or constipation.
What does the study involve?
Participants will be divided into two groups: one group will receive 1.5 g of sodium butyrate daily, while the other group will receive a placebo. During the first visit and the second visit, 12 weeks later, blood samples will be collected to measure glucose, insulin, and glycated hemoglobin levels, and a hydrogen breath test will be performed to assess for SIBO.
What are the possible benefits and risks of participating?
Potential benefits of the study include alleviation of irritable bowel syndrome symptoms and improved carbohydrate metabolism control. To date, no side effects of sodium butyrate use have been reported.
Where is the study run from?
The study is being conducted at the Clinic of Gastroenterology and Internal Medicine, National Medical Institute, Ministry of Internal Affairs and Administration (PIM MSWiA), Poland
When is the study starting and how long is it expected to run for?
January 2021 to August 2023
Who is funding the study?
1. The Clinic of Gastroenterology and Internal Medicine, National Medical Institute, Ministry of Internal Affairs and Administration (PIM MSWiA), Poland
2. Sodium butyrate and placebo will be provided by the manufacturer, Bioton, Poland
Who is the main contact?
Paulina Panufnik, paulina.panufnik@cskmswia.gov.pl
Contact information
Public, Scientific, Principal Investigator
Wołoska 137 st.
Warsaw
02-507
Poland
 ORCID ID |
0000-0003-0934-4590 |
|---|---|
| Phone | +48477221240 |
| paulina.panufnik@cskmswia.gov.pl |
Study information
| Study design | Single-centre interventional double-blinded, placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | The effect of microencapsulated sodium butyrate on abdominal symptoms and carbohydrate metabolism in patients with type 2 diabetes: a randomized placebo-controlled trial |
| Study objectives | Sodium butyrate supplementation reduces the severity of gastrointestinal symptoms and improves carbohydrate metabolism. |
| Ethics approval(s) |
Approved 21/04/2021, The Bioethics Committee of the National Medical Institute of the Ministry of Internal Affairs and Administration (Woloska 137, Warsaw, 02-507, Poland; +48477221552; komisja.etyki@cskmswia.gov.pl), ref: 55/2021 |
| Health condition(s) or problem(s) studied | Treatment of gastrointestinal symptoms and improvement of carbohydrate metabolism in patients with type 2 diabetes. |
| Intervention | The study will include patients with type 2 diabetes who meet the Rome IV criteria for the diagnosis of irritable bowel syndrome (IBS). Participants will be randomized, using an application, into two groups: one receiving 1.5 g of sodium butyrate daily for 12 weeks and the other receiving a placebo. During two visits, at weeks 0 and 12, patients will undergo laboratory tests, a lactulose hydrogen breath test to diagnose SIBO, and will complete a questionnaire assessing the severity of gastrointestinal symptoms. |
| Intervention type | Supplement |
| Primary outcome measure | 1. Changes in carbohydrate metabolism will be measured by assessing glycated hemoglobin (HbA1c) levels and calculating the HOMA-IR index at the start of the study and after the 12-week intervention. 2. Changes in the severity of gastrointestinal symptoms will be evaluated using a gastrointestinal symptom severity questionnaire, completed by participants at the start of the study and after the 12-week intervention. |
| Secondary outcome measures | 1. The presence of small intestinal bacterial overgrowth (SIBO) in patients will be assessed through a hydrogen breath test conducted at the start of the study and after the 12-week intervention 2. Fasting insulin levels in the blood of participants were measured using venous blood samples at the beginning of the study and after the 12-week intervention 3. Fasting glucose levels in the blood of participants were measured using venous blood samples at the beginning of the study and after the 12-week intervention |
| Overall study start date | 02/01/2021 |
| Completion date | 03/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 52 |
| Key inclusion criteria | 1. Age: 18–80 years. 2. Diagnosed type 2 diabetes with no modifications to treatment for at least 3 months. 3. Meeting the Rome IV criteria for the diagnosis of irritable bowel syndrome (IBS). |
| Key exclusion criteria | 1. Age > 80 years or <18 2. Any changes in treatment within 3 months before qualification and/or during the study 3. Dietary interventions 4 weeks before qualification and/or during the study 4. Use of antibiotics 4 weeks before qualification and/or during the study 5. Use of prokinetics, antidiarrheal drugs, probiotics, sodium butyrate, proton pump inhibitors or H2 receptor blockers 14 days before qualification and/or during the study 6. Pregnancy or breastfeeding 7. Lactulose intolerance 8. Diagnosis of galactosemia |
| Date of first enrolment | 01/10/2022 |
| Date of final enrolment | 01/07/2023 |
Locations
Countries of recruitment
- Poland
Study participating centre
Warsaw
02-507
Poland
Sponsor information
Hospital/treatment centre
Clinic of Gastroenterology and Internal Medicine, National Medical Institute, Ministry of Interior and Administration
Woloska 137 st.
Warsaw
02-507
Poland
| Phone | +48477221242 |
|---|---|
| gastroenterologia@cskmswia.gov.pl | |
| Website | https://www.gov.pl/web/cskmswia/klinika-chorob-wewnetrznych-i-gastroenterologii |
"ROR" |
https://ror.org/03c86nx70 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Paulina Panufnik (paulina.panufnik@cskmswia.gov.pl) 1. The type of data that will be shared: The study results and patient data, such as age, type of treatment, and anonymized information, will be shared. 2. Timing for availability: The data is already available. 3. Whether consent from participants was required and obtained: Consent was required and obtained. 4. Comments on data anonymization: The data has been anonymized. 5. Any ethical or legal restrictions: Approval from the bioethics committee has been obtained |
Editorial Notes
21/01/2025: Trial's existence confirmed by The Bioethics Committee of the National Medical Institute of the Ministry of Internal Affairs and Administration.
