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

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT04908904

Collaborator

Aarhus University Hospital (Other)

Enrollment

Location

Arms

8.7

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Dietary Supplement: Cafestol Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 27, 2021

Actual Primary Completion Date :

Feb 16, 2022

Actual Study Completion Date :

Feb 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cafestol 12 mg cafestol	Dietary Supplement: Cafestol Capsule with 12 mg cafestol
Placebo Comparator: Placebo Placebo	Dietary Supplement: Placebo Placebo capsule without cafestol

Arm

Intervention/Treatment

Active Comparator: Cafestol

12 mg cafestol

Dietary Supplement: Cafestol

Capsule with 12 mg cafestol

Placebo Comparator: Placebo

Placebo

Dietary Supplement: Placebo

Placebo capsule without cafestol

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Steno Diabetes Center Aarhus	Aarhus	Aarhus N	Denmark	8200

Sponsors and Collaborators

University of Aarhus
Aarhus University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT04908904

Other Study ID Numbers:

cafestol.acute.t2d

First Posted:

Jun 1, 2021

Last Update Posted:

Feb 28, 2022

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Aarhus

Diabetes Mellitus, Type 2

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Feb 28, 2022