Acute Effects of Cafestol on Glucose Metabolism in Subjects With Type-2-diabetes.

Study Overview
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Brief Summary
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Acute, double-blinded, randomized, cross-over cafestol intervention study with sixteen participants with T2D participating in two OGTTs.

Detailed Description
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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.

Official Title
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Acute Effects of Cafestol on Glucose Metabolism in Subjects With Type-2-diabetes.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Cafestol
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cafestol<br>12 mg cafestol | Dietary Supplement: Cafestol<br>* Capsule with 12 mg cafestol<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* Placebo capsule without cafestol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2