None listed
Conditions
Brief summary
Type 2 Diabetes (T2DM) affects around 7% of the adult NZ population. 25% have prediabetes. Obesity is a risk factor for T2DM. One potential mechanism is due to the proinflammatory cytokines released from adipose tissue. In mice high fat diets result in obesity and loss of sensitivity to insulin. It has been demonstrated that purified plant metabolites from Dahlia spp. as well as the plant extract significantly improve glucose homeostasis in high fat diet diabetic mice. This study is a First in Human study of the effect of these compounds on humans. Twenty male participants aged 18-65 with prediabetes (HbA1c 4149 mmol/mol) will be recruited for this study. Each participant will receive three different doses (0.5, 1 and 2 mg/m2) of a Dahlia spp. extract. The study will look at glucose handling following the ingestion of the extract and compare this to glucose handling without exposure to these using an oral glucose tolerance test.
Interventions
An extract of Dahlia spp. will be given at 3 different dosages on one occasion per dose, and an oral glucose tolerance test performed with each dosage. The doses will be 0.5, 1 and 2 mg/m2 given as capsules. All participants will receive all three doses with a one week washout period. The doses will be administered by a research nurse.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
No
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
Outcome results
None listed