Acute Effects of Cafestol on Glucose Metabolism in Subjects With Type-2-diabetes.
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Details and patient eligibility
About
Acute, double-blinded, randomized, cross-over cafestol intervention study with sixteen participants with T2D participating in two OGTTs.
Full description
The study is an acute, double-blinded, randomized, cross-over intervention study with sixteen participants with T2D. Initially, a blood sample is obtained (t=-15 min) and at time point 0, the participants will ingest a tablet containing either 12 mg cafestol or placebo. Immediately hereafter an OGTT commences with ingestion of a 75 g glucose solution. In the following 3 hours blood samples are collected at time points 0, 15, 30, 60, 90, 120 and 180 min. The samples will be used for determination of plasma glucose, insulin and cafestol, as well as GLP-1 and GIP. After a one-week washout period, the subject will undergo the same set-up again, however now with the opposite intervention / placebo.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Type 2 Diabetes defined by standard Danish guidelines
- HbA1c ≥48 mmol/mol unless successfully treated with antidiabetic drugs and/or diet/exercise intervention
Exclusion criteria
- In treatment with insulin
- Pregnancy
- Planned pregnancy
- Breastfeeding
- Significant comorbidity expected to unable the subject from completing visits
Trial design
Primary purpose
Allocation
Interventional model
Masking
16 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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