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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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Acute, double-blinded, randomized, cross-over cafestol intervention study with fifteen participants with a large waist circumference participating in three OGTTs.
The study is a acute, double-blinded, randomized, controlled intervention in 15 subjects with abdominal obesity at high risk of developing T2D. Initially, a blood sample is obtained (t=-15 min) and at time point 0, the participants will ingest a capsule containing either 6 or 12mg cafestol or placebo. Immediately hereafter an OGTT commences with ingestion of a 75 g glucose solution. In the following 2 hours blood samples are collected at time points 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 different dosage of cafestol or placebo. The process is repeated for three weeks until every subject has undergone both interventions and the placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cafestol 6 mg | Active Comparator | 6 mg cafestol |
|
| Cafestol 12 mg | Active Comparator | 12 mg cafestol |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cafestol 12 mg | Dietary Supplement | Capsule with 12 mg cafestol |
| |
| 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 (mmol/L) | -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 (pmol/L) | -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:
25 < BMI < 40 kg/m2 Waist circumference > 102 cm (men) / 88 cm (women)
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 |
|---|---|
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| C053400 | cafestol |
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| Placebo |
| Dietary Supplement |
Placebo capsule without cafestol |
|
| Cafestol 6 mg | Dietary Supplement | Capsule with 6 mg 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 (glucagon-like peptide-1) | Area under the curve for GLP-1 (glucagon-like peptide-1) during OGTT after ingestion of cafestol or placebo capsule (pmol/L) | -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) | Area under the curve for GIP (Glucose-dependent insulinotropic polypeptide) during OGTT after ingestion of cafestol or placebo capsule (pmol/L) | -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |