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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 16, 2022

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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Cafestol
    • 12 mg cafestol
  • Placebo Comparator: Placebo
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Area under the curve for glucose
    • Time Frame: -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 Measures

  • Area under the curve for insulin-response
    • Time Frame: -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
    • Time Frame: -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
    • Time Frame: -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
  • Area under the curve for GIP
    • Time Frame: -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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Aarhus
  • Collaborator
    • Aarhus University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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