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

NCT ID: NCT04908904

Last Updated: 2022-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-27

Study Completion Date

2022-02-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cafestol

12 mg cafestol

Group Type ACTIVE_COMPARATOR

Cafestol

Intervention Type DIETARY_SUPPLEMENT

Capsule with 12 mg cafestol

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo capsule without cafestol

Interventions

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Cafestol

Capsule with 12 mg cafestol

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo capsule without cafestol

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Steno Diabetes Center Aarhus

Aarhus, Aarhus N, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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cafestol.acute.t2d

Identifier Type: -

Identifier Source: org_study_id

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