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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Cafestol

• Registration Number: NCT04908904
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Status Verified: 2021-05
• Study Start: 2021-05-27
• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-06-01
• Primary Completion: 2022-02-16
• Study Completion: 2022-02-16
• Last Update Submitted: 2022-02-25
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Cafestol	Cafestol	12 mg cafestol

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Steno Diabetes Center Aarhus; 🇩🇰 Aarhus, Aarhus N, Denmark