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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

Tracking Information
First Submitted Date  ICMJE May 27, 2021
First Posted Date  ICMJE June 1, 2021
Last Update Posted Date June 1, 2021
Estimated Study Start Date  ICMJE May 19, 2021
Estimated Primary Completion Date September 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2021)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2021)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Effects of Cafestol on Glucose Metabolism in Subjects With Type-2-diabetes.
Official Title  ICMJE Acute Effects of Cafestol on Glucose Metabolism in Subjects With Type-2-diabetes.
Brief Summary Acute, double-blinded, randomized, cross-over cafestol intervention study with sixteen participants with T2D participating in two OGTTs.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Dietary Supplement: Cafestol
    Capsule with 12 mg cafestol
  • Dietary Supplement: Placebo
    Placebo capsule without cafestol
Study Arms  ICMJE
  • Active Comparator: Cafestol
    12 mg cafestol
    Intervention: Dietary Supplement: Cafestol
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2021)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2023
Estimated Primary Completion Date September 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fredrik B Mellbye, M.D. +4526844425 fbmellbye@clin.au.dk
Contact: Søren Gregersen, M.D. Ph.D +4530134245 soeren.gregersen@aarhus.rm.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04908904
Other Study ID Numbers  ICMJE cafestol.acute.t2d
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Aarhus University Hospital
Investigators  ICMJE Not Provided
PRS Account University of Aarhus
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP