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

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ClinicalTrials.gov Identifier: NCT04908904
Recruitment Status : Recruiting
First Posted : June 1, 2021
Last Update Posted : June 1, 2021
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Estimated Study Start Date : May 19, 2021
Estimated Primary Completion Date : September 19, 2021
Estimated Study Completion Date : August 30, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04908904


Contacts
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Contact: Fredrik B Mellbye, M.D. +4526844425 fbmellbye@clin.au.dk
Contact: Søren Gregersen, M.D. Ph.D +4530134245 soeren.gregersen@aarhus.rm.dk

Locations
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Denmark
Steno Diabetes Center Aarhus Recruiting
Aarhus, Aarhus N, Denmark, 8200
Contact: Fredrik B Mellbye, M.D.    +4526844425    fbmellbye@clin.au.dk   
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04908904    
Other Study ID Numbers: cafestol.acute.t2d
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Diabetes Mellitus, Type 2
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases