A randomised clinical trial testing the safety of and metabolic responses to short-term duodenal infusion of recombinant RORDEP1 in healthy men
Authors' conclusion
Short-term duodenal infusion of r-RORDEP1 is safe and well tolerated and elicits changes in plasma incretins, insulin and glucose, and a measure of whole-body insulin sensitivity, aligning with findings in rodents, supporting the hypothesis that RORDEPs hold a role in impacting host metabolism.
Study context
- Population
- Healthy, normal-weight men aged 18–35 years without medication, recent antibiotics, lactose intolerance, smoking, alcohol or drug abuse, probiotics or creatine; Gentofte Hospital, Denmarkall completed
- Participants
- 17 participants
- Comparison
- Duodenal infusion of recombinant RORDEP1 (r-RORDEP1) vs placebo after a liquid mixed meal
- Primary endpoint
- Changes in plasma concentrations of incretins and peptide YY
Methodological detailsplacebo-controlled, crossover, block randomisation, participants and investigators blinded
- Placebo-controlled
- Crossover
- Block randomisation
- Participants and investigators blinded
Primary result
As reported in the abstract
Plasma incretins vs placebo · early (15 or 30 min)
Rise in plasma GLP-1 with r-RORDEP1 bolus vs placebo
q=0.001
Decline in plasma gastric inhibitory polypeptide with r-RORDEP1 bolus vs placebo
q=0.02
Secondary outcomes
| Outcome | P value |
|---|---|
| Whole-body insulin sensitivity (Matsuda index)Increased with r-RORDEP1 | P = 0.049 |
Plasma insulin, C-peptide and glucose vs placebo · early (15 or 30 min)
- Rise in plasma insulin
- q=0.001
- Rise in plasma C-peptide
- q=0.003
- Decline in plasma glucose
- q=0.006
Safety
Safety and tolerability
- r-RORDEP1 was well tolerated, without changes in biochemical measures of haematological, liver or renal functions
Original publication
A randomised clinical trial testing the safety of and metabolic responses to short-term duodenal infusion of recombinant RORDEP1 in healthy men. Diabetologia. Published 23 May 2026. doi:10.
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