University Hospital Basel
Basel, 4031, Switzerland
NCT Number: NCT02127047
Increasing evidence suggests pancreatic islet beta-cell regeneration occurs throughout the course of the disease in patients with type 1 diabetes. Therefore, decreased beta-cell mass in type 1 diabetes may be improved through inhibition of beta-cell destruction and stimulation of proliferation, even after prolonged duration of disease.
Physical activity improves insulin secretion via unknown underlying mechanisms. We recently observed that Interleukin-6 induces glucagon like Peptide (GLP)-1 production and release from the islet alpha-cell and the intestinal L-cell. Furthermore, exercise induces release of Interleukin-6 from skeletal muscle resulting in elevated circulating Interleukin-6 levels. Therefore we hypothesize that exercise-induced Interleukin-6 promotes glucagon like peptide-1 secretion from the islet α-cell and the intestinal L-cell, thereby providing a mechanism how physical activity can help maintain and improve beta-cell function in patients with type 1 diabetes. This mechanism can be enhanced by concomitant dipeptidyl peptidase-IV inhibition.
Physical activity is also known to enhance insulin sensitivity and to attenuate the immune system activity.
Therefore by combining physical activity and dipeptidyl peptidase-IV inhibition we aim to allow for beta-cell regeneration in a interventional randomized open-label study.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 2
Basel, 4031, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day 90 compared to baseline (Day 1 pre-dose)
Time frame: Day 90 compared to baseline (Day 1 pre-dose)
Time frame: baseline (Day -3 through Day -1) compared to Day 90 (Day 87 through Day 89)
Time frame: baseline (Day 1 pre-dose) at Day 90
Time frame: baseline (Day 1 pre-dose) at Day 90
Time frame: baseline (Day 1 pre-dose) at Day 90
Time frame: baseline (Day 1 pre-dose) to Day 90
Time frame: from baseline (Day 1 pre-dose) at Day 90
Time frame: from baseline at Day 90
Time frame: Day 90 compared to baseline
Time frame: baseline at Day 90
Time frame: from baseline at Day 90
Time frame: from baseline (Day 1 pre-dose) at Day 90
Time frame: Day 90 compared to baseline (Day 1 pre-dose)
Time frame: Day 90 compared to baseline (Day 1 pre-dose)
Time frame: Day 90 compared to baseline (Day 1 pre-dose)
University Hospital, Basel, Switzerland
Other
Acronym: EXTYPE-1
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