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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: Cafestol; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N
    • Aarhus, Aarhus N, Denmark, 8200
      • Steno Diabetes Center Aarhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo capsule without cafestol
Active Comparator: Cafestol; 12 mg cafestol	Dietary supplement: Cafestol; Capsule with 12 mg cafestol

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2021
• Primary Completion (Actual): February 16, 2022
• Study Completion (Actual): February 16, 2022

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes Mellitus, Type 2
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: cafestol.acute.t2d

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No