Can taking a plant extract improve blood glucose in adult men with pre-diabetes? First in human study
Phase 1
Completed
- Conditions
- Pre-DiabetesDiabetesMetabolic and Endocrine - DiabetesAlternative and Complementary Medicine - Herbal remedies
- Registration Number
- ACTRN12617001605381
- Lead Sponsor
- niversity of Otago
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 16
Inclusion Criteria
Males aged 18-65 years with pre-diabetes (HbA1c 41-49 mmol/mol)
Exclusion Criteria
Any prior history of diabetes or taking glucose lowering medication
Previous bariatric surgery
Liver disease or AST/ ALT >3x ULN, Renal disease or eGFR <60.
Known cardiac disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the curve glucose[Baseline, visits 1, 2 and 3. Blood samples will be collected at 30 minute intervals during the oral glucose tolerance test for 3 hours. ];Area under the curve insulin[Baseline, visits 1, 2 and 3. Blood samples will be collected at 30 minute intervals during the oral glucose tolerance test for 3 hours. ]
- Secondary Outcome Measures
Name Time Method Safety measures - liver function, full blood count and kidney function as a composite outcome[Blood tests will be done the day before and day after the intervention to check liver function and full blood count and kidney function. <br>];C-peptide[Baseline, Visits 1, 2 and 3];Blood pressure, heart rate, saturations, respiratory rate, temperature as a composite outcome reported as acute adverse events. [Observations done every 30 mins for 5 hours following administration of dose 1, 2 and 3 but not at baseline. ]