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NCT06384313
Butyrate-enriched Triglyceride and Diabetes Prevention
NA trial testing butyrate/hexanoate-enriched triglycerides in Type 2 Diabetes in 48 participants. Currently enrolling.
1 September 2027
Quick facts
| Lead sponsor | Maastricht University Medical Center |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 48 |
| Start date | 19 September 2024 |
| Primary completion | 1 September 2027 |
| Estimated completion | 1 September 2027 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- butyrate/hexanoate-enriched triglycerides
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
- PreDiabetes — all drugs for PreDiabetes →
- Obesity — all drugs for Obesity →
Sponsor
Maastricht University Medical Center
Who can join
Adults 20 to 70, any sex, with Type 2 Diabetes or PreDiabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A body of animal studies as well as observational studies in humans demonstrated that butyrate is one SCFA that has pronounced positive effects on body weight control, inflammation, and insulin resistance. Even though the SCFA hexanoate is less researched, it has been shown to be involved in anti-inflammatory processes. Of note, acute human studies showed that fibre-induced metabolic improvements are linked to higher SCFA levels in the systemic circulation. It has been shown that a butyrate/hexanoate-enriched triglyceride oil enhanced systemic butyrate and hexanoate concentrations for a prolonged time. Yet, it remains to be determined whether a chronic increase in circulating butyrate and hexanoate concentrations translate into long-term benefits. In this study it is hypothesized that a chronic increase of butyrate/hexanoate in the circulation may improve host metabolism and metabolic health by improving adipose tissue function, reducing systemic lipid overflow and inflammation thereby increasing peripheral insulin sensitivity in individual with overweight/obesity and prediabetes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06384313
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06384313 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Maastricht University Medical Center
- Last refreshed: 26 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06384313.
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