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Completed

NCT Number: NCT04908904

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Aarhus

Aarhus, Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cafestol

Dietary Supplement

Capsule with 12 mg cafestol

Placebo

Dietary Supplement

Placebo capsule without cafestol

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2021
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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