Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, Type 2
Brief summary
Acute, double-blinded, randomized, cross-over cafestol intervention study with sixteen participants with T2D participating in two OGTTs.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTCafestol
Capsule with 12 mg cafestol
DIETARY_SUPPLEMENTPlacebo
Placebo capsule without cafestol
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve for glucose | -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution | Area under the curve for glucose during OGTT after ingestion of cafestol or placebo capsule |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve for insulin-response | -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution | Area under the curve for insulin response during OGTT after ingestion of cafestol or placebo capsule |
| Area under the curve for cafestol | -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution | Area under the curve for cafestol during OGTT after ingestion of cafestol or placebo capsule |
| Area under the curve for GLP-1 | -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution | Area under the curve for GLP-1 (glucagon-like peptide-1) during OGTT after ingestion of cafestol or placebo capsule |
| Area under the curve for GIP | -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution | Area under the curve for GIP (Glucose-dependent insulinotropic polypeptide) during OGTT after ingestion of cafestol or placebo capsule |
Countries
Denmark
Outcome results
None listed