Prediabetic State Clinical Trial
Official title:
Clinical Study to Assess the Long-term Effect of Pep2Dia® on Glucose Homeostasis in Prediabetic Subjects: a 12-week Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel Study
NCT number | NCT05391854 |
Other study ID # | BTS1777/21 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 21, 2022 |
Est. completion date | June 20, 2023 |
Verified date | June 2023 |
Source | Ingredia S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 128 |
Est. completion date | June 20, 2023 |
Est. primary completion date | May 5, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 70 Years |
Eligibility | Inclusion Criteria: - Male and female subjects (minimum one third of each gender) with prediabetic HbA1c values between 5.7% and 6.4% and/or fasting glucose = 5.6 mmol/L (= 100 mg/dL) and < 7.0 mmol/L (< 125 mg/dL) (in venous plasma) (twice confirmed at two independent days if HbA1c is < 5.7%) - Age: 25-70 years - Body mass index 19-35 kg/m2 - Current Non-smoker - Availability and presence in the study units for approx. 3.5 hours/ week for 2 times. - Signed informed consent form - No changes in food habits or physical activity 3 months prior to screening and during the study - If applicable, stable intake of chronic medication of at least 4 weeks Exclusion Criteria: - Subjects with diagnosed Type 2-Diabetes with medical treatment - Presence of disease or drug(s) influencing digestion and absorption of nutrients - Intake of medications known to affect glucose tolerance, e.g., diabetic medication SGLT-2 inhibitors, GLP-1 receptor agonists, steroids, protease inhibitors or antipsychotics - Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening)), which in the Investigator's opinion would impact patient safety - Severe liver or renal disease or laboratory evidence of hepatic dysfunction (i.e. alkaline phosphatase, ALT, AST >3 x ULN) - Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks - Known inflammatory or malignant gastrointestinal diseases (i.e. colitis ulcerosa, Morbus Crohn, celiac disease, malignant diseases e.g. colon-cancer, rectum cancer, pancreatitis) - Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs - Major medical or surgical event requiring hospitalization within the previous 3 months - Intake of food supplements known to affect glucose tolerance, e.g., cinnamon capsules, conjugated linoleic acids, omega-3 fatty acids - Intake of antibiotics within 4 weeks before the test days - Known alcohol abuse or drug abuse - Pregnant or breast-feeding women - Weight loss intervention or recent body weight change >5 kg during last 3 months - Known or suspected allergy to any component of the investigational product(s) (e.g. milk protein) - Blood donation within 4 weeks prior to Visit 1 or during the study - Anticipating any planned changes in lifestyle for the duration of the study - Participation in another clinical intervention study within the last 4 weeks and concurrent participation in another intervention clinical study - Subject unable to co-operate adequately |
Country | Name | City | State |
---|---|---|---|
Germany | Biotesys | Esslingen |
Lead Sponsor | Collaborator |
---|---|
Ingredia S.A. | BioTeSys GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Secondary | 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 | |
Secondary | Cmax | Maximum blood glucose concentration | Day 1; Day 85 | |
Secondary | Delta Cmax | Maximum increase of glucose (Cmax minus baseline value) | Day 1; Day 85 | |
Secondary | Tmax | Time to reach maximum blood glucose concentration | Day 1; Day 85 | |
Secondary | Tbaseline | First time to reach baseline again after increase or decrease in blood glucose | Day 1; Day 85 | |
Secondary | ISI 0-120min | Day 1; Day 85 | ||
Secondary | hsCRP | Day 1; Day 85 | ||
Secondary | GLP-1 | Day 1; Day 85 | ||
Secondary | Body composition measurement | Evaluation of the fat mass/lean mass ratio by bioelectrical impedance analysis | Day 1; Day 85 | |
Secondary | SF-12 (Short-fom 12) | Score from 12 to 60. Higher score mean a better outcome. | Day 1; Day 85 |
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