Diabetes Mellitus Clinical Trial
Official title:
25gr. Glucomedics vs 25gr. Zusto
Objective: to compare blood glucose and insulin responses after consumption of 100ml water, sweetened with 25gr Zusto® and 100ml water sweetened with 25gr Glucomedics® (standard drink)
This is an experimental study enrolling 10 healthy female subjects. The study compares the
blood glucose and insulin responses after consumption of 100ml water, sweetened with 25gr
Zusto® and 100ml water sweetened with 25gr Glucomedics® (standard drink). Subjects need to
be fasted for at least 8 hours before all visits. At visit 1, five women will consume the
solution with 25gr Zusto®, the other five will have the solution with 25gr Glucomedics®. On
visit 2, groups will be switched. Visit 1 and 2 will be performed within approximately one
week interval.
Both drinks will be identical in amount of water and only be different by the use of 25gr
Glucomedics® and 25gr Zusto®.
Before intake of the drink, vital signs, weight and bedside blood glucose and baseline blood
samples - 15' and 0' for glucose, insulin and C-peptide will be taken at visit 1 and 2. Both
drinks will be consumed within 5 minutes and time of start and end of intake of Zusto® /
Glucomedics® will be documented.
Blood samples for glucose, insulin and C-peptide will be taken at 15', 30', 60', 90', 120'
and 180' after start of intake 25gr Zusto® and 25gr Glucomedics®.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
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