NCT04908904

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 27, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2022

Completed
Last Updated

February 28, 2022

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

May 27, 2021

Last Update Submit

February 25, 2022

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Area under the curve for glucose

    Area under the curve for glucose during OGTT after ingestion of cafestol or placebo capsule

    -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution

Secondary Outcomes (4)

  • 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 cafestol

    -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution

  • 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 GIP

    -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution

Study Arms (2)

Cafestol

ACTIVE COMPARATOR

12 mg cafestol

Dietary Supplement: Cafestol

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

CafestolDIETARY_SUPPLEMENT

Capsule with 12 mg cafestol

Cafestol
PlaceboDIETARY_SUPPLEMENT

Placebo capsule without cafestol

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes defined by standard Danish guidelines
  • HbA1c ≥48 mmol/mol unless successfully treated with antidiabetic drugs and/or diet/exercise intervention

You may not qualify if:

  • In treatment with insulin
  • Pregnancy
  • Planned pregnancy
  • Breastfeeding
  • Significant comorbidity expected to unable the subject from completing visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus, Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

cafestol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2021

First Posted

June 1, 2021

Study Start

May 27, 2021

Primary Completion

February 16, 2022

Study Completion

February 16, 2022

Last Updated

February 28, 2022

Record last verified: 2021-05

Locations

DK(1)