The goal is to assess the long-term effect of Pep2Dia® compared to placebo intake on blood glucose homeostasis. Respective improvements will be assessed by changes in glycated haemoglobin (HbA1c) before and after the 12-weeks intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
128
Biotesys
Esslingen am Neckar, Germany
Glycated haemoglobin (HbA1c)
Change from baseline Glycated haemoglobin (HbA1c) at 3 months
Time frame: Before treatment (baseline = day 0); at the end of the treatment (after 3 months = day 85)
Glucose-iAUC(0-180min)
Area under the curve calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration
Time frame: Day 1; Day 85
Cmax
Maximum blood glucose concentration
Time frame: Day 1; Day 85
Delta Cmax
Maximum increase of glucose (Cmax minus baseline value)
Time frame: Day 1; Day 85
Tmax
Time to reach maximum blood glucose concentration
Time frame: Day 1; Day 85
Tbaseline
First time to reach baseline again after increase or decrease in blood glucose
Time frame: Day 1; Day 85
ISI 0-120min
Time frame: Day 1; Day 85
hsCRP
Time frame: Day 1; Day 85
GLP-1
Time frame: Day 1; Day 85
Body composition measurement
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Evaluation of the fat mass/lean mass ratio by bioelectrical impedance analysis
Time frame: Day 1; Day 85
SF-12 (Short-fom 12)
Score from 12 to 60. Higher score mean a better outcome.
Time frame: Day 1; Day 85