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The goal of the study is to examine the difference of the pharmacokinetics of metformin with and without a 3 weeks pretreatment of St John's Wort. Furthermore secondary objectives include changes in GLP-1, C-peptide, serum-insulin and plasma-glucose during an oral glucose tolerance test, changes in OCT1 mRNA in plasma and changes in leptin and lipid-profile following this possible interaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental | 7 days of pretreatment with metformin before full pharmacokinetics and other goals are investigated. Minimum 1 week of washout after this period. 3 weeks of pretreatment with St John's Wort and the last 7 days metformin is ingested again, and the same effect parameters as described above is performed again |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| St John's Wort | Other |
| ||
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Area Under Curve (AUC) 0-24h of metformin | Change in 0-24h AUC of metformin after 3 weeks of treatment with St John's Wort | Concentration of metformin at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hours after metformin ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| Oral glucose tolerance test (OGTT) | Changes in: Plasma-glucose, serum-insulin, glucagon-like peptide 1 (GLP-1) and connecting-peptides (C-peptides) during the oral glucose tolerance test, measured at 0, 0.5, 1, 1.5 and 2 hours after metformin ingestion. | During the first 2 hours of each metformin ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| Hypericin/hyperforin | If possible measure the concentrations of some of the active components of St John's Wort, hypericin and hyperforin | At t=0 in 2nd period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Damkier, MD ph.d. | University of Southern Denmark | Principal Investigator |
| Tore B. Stage, M.Sc. Pharm | University of Southern Denmark | Principal Investigator |
| Kim Brøsen, Professor, MD | University of Southern Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark | Odense | DK-5000 | Denmark |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C422326 | Hypericum extract LI 160 |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
| Pharmacokinetics of metformin |
Determination of other pharmacokinetic parameters of metformin such as clearance (CL), absorption fraction (F), distribution volume (V), the minimum concentration at steady state (Css,min), elimination half life (T 1/2) etc. |
| Concentration of metformin at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hours after metformin ingestion, which will be used to determine the pharmacokinetic parameters mentioned below |
| Change in messenger RiboNucleic Acid (mRNA) | Changes in mRNA encoding OCT1 will be measured at 4 different time points to give an insight to the importance of St John's Wort effect on the OCT1 production | Will be measured 4 times: At inclusion (t=0 on that day), at t=0 in both periods and minimum 3 weeks after finalization of the study (t=0 on that day) |
| D004700 | Endocrine System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |