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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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Acute, double-blinded, randomized, cross-over cafestol intervention study with sixteen participants with T2D participating in two OGTTs.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cafestol | Active Comparator | 12 mg cafestol |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cafestol | Dietary Supplement | Capsule with 12 mg cafestol |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve for glucose | Area under the curve for glucose during OGTT after ingestion of cafestol or placebo capsule | -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve for insulin-response | Area under the curve for insulin response during OGTT after ingestion of cafestol or placebo capsule | -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution |
| Area under the curve for cafestol |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Aarhus | Aarhus | Aarhus N | 8200 | Denmark |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C053400 | cafestol |
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| Dietary Supplement |
Placebo capsule without cafestol |
|
Area under the curve for cafestol during OGTT after ingestion of cafestol or placebo capsule |
| -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution |
| Area under the curve for GLP-1 | Area under the curve for GLP-1 (glucagon-like peptide-1) during OGTT after ingestion of cafestol or placebo capsule | -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution |
| Area under the curve for GIP | Area under the curve for GIP (Glucose-dependent insulinotropic polypeptide) during OGTT after ingestion of cafestol or placebo capsule | -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution |
| D004700 | Endocrine System Diseases |