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| Name | Class |
|---|---|
| BioTeSys GmbH | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pep2dia | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pep2dia | Dietary Supplement | 700 mg Pep2Dia® 15 min prior to breakfast and 700 mg Pep2Dia® 15 min prior to dinner |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycated haemoglobin (HbA1c) | Change from baseline Glycated haemoglobin (HbA1c) at 3 months | Before treatment (baseline = day 0); at the end of the treatment (after 3 months = day 85) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1; Day 85 |
| Cmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotesys | Esslingen am Neckar | Germany |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Dietary Supplement | 700 mg placebo 15 min prior to breakfast and 700 mg placebo 15 min prior to dinner |
|
Maximum blood glucose concentration
| Day 1; Day 85 |
| Delta Cmax | Maximum increase of glucose (Cmax minus baseline value) | Day 1; Day 85 |
| Tmax | Time to reach maximum blood glucose concentration | Day 1; Day 85 |
| Tbaseline | First time to reach baseline again after increase or decrease in blood glucose | Day 1; Day 85 |
| ISI 0-120min | Day 1; Day 85 |
| hsCRP | Day 1; Day 85 |
| GLP-1 | Day 1; Day 85 |
| Body composition measurement | Evaluation of the fat mass/lean mass ratio by bioelectrical impedance analysis | Day 1; Day 85 |
| SF-12 (Short-fom 12) | Score from 12 to 60. Higher score mean a better outcome. | Day 1; Day 85 |
| D004700 | Endocrine System Diseases |