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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908904
• Other study ID #: cafestol.acute.t2d
• Status: Completed
• Phase: N/A
• Start date: May 27, 2021
• Est. completion date: February 16, 2022

Study information

• Verified date: May 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 16, 2022
• Est. primary completion date: February 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Cafestol
Capsule with 12 mg cafestol
• Placebo
Placebo capsule without cafestol

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Aarhus	Aarhus	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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