NCT01921881

Brief Summary

The goal of the study is to examine if healthy individuals that ingest St John's wort will have a significantly difference in glucose tolerance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1 type-2-diabetes

Timeline
Completed

Started Sep 2013

Typical duration for phase_1 type-2-diabetes

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

August 9, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

1.2 years

First QC Date

August 9, 2013

Last Update Submit

February 12, 2015

Conditions

Type 2 Diabetes

Keywords

Glucose tolerance

Outcome Measures

Primary Outcomes (1)

  • Glucose area under curve (AUC) 0-2 hours

    At time=0, the subjects will ingest 75g glucose. Plasma glucose will be measured at 0, 15, 30, 45, 60, 90 and 120 minutes after glucose ingestion.

    Glucose concentration 0, 15, 30, 45, 60, 90 and 120 after glucose ingestion

Secondary Outcomes (2)

  • St John's wort pharmacokinetics

    At time=0

  • Other metabolic markers

    At time points, 0, 15, 30, 45, 60, 90, 120 minutes after glucose ingestion

Study Arms (1)

St John's wort

EXPERIMENTAL

Subjects will undergo 3 oral glucose tolerance tests: 1. Without taking any St John's wort 2. After 3 weeks pretreatment with St John's wort 3. Minimum 6 weeks after last St John's wort ingestion

Other: St John's wort

Interventions

St John's wortOTHER
St John's wort

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • Males
  • Fasting plasma-glucose \< 7.0 mmol/L
  • Glycosylated haemoglobin A1c within reference or clinically insignificant deviation hereof
  • Body mass index \< 30 kg/m\^2

You may not qualify if:

  • Hypersensitivity to St John's wort
  • Chronical or daily alcohol abuse
  • Known liver disease
  • Ingestion of drugs requiring prescription, except locally acting drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark

Odense C, DK-5000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Hypericum extract LI 160

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kim Brøsem, Professor, MD

    University of Southern Denmark

    STUDY DIRECTOR

  • Per Damkier, MD PhD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

  • Tore B. Stage, MSc Pharm

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Pharm

Study Record Dates

First Submitted

August 9, 2013

First Posted

August 13, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 13, 2015

Record last verified: 2015-02

Locations

DK(1)