Prediabetic State
Conditions
Brief summary
The goal is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of Pep2Dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15 min prior to a standardized challenge meal.
Detailed description
From a previous pilot study (BTS1130/17) there is first evidence that the native whey product with alpha-glucosidase inhibiting properties (Pep2Dia®) has the potential to modulate postprandial hyperglycaemia in prediabetic subjects. Thereby, incremental areas under the curve (iAUC) of glucose as the primary outcome were significantly reduced by a single dosage of 1400 mg Pep2Dia® compared to placebo the second study is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of Pep2Dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15 min prior to a standardized challenge meal. Furthermore, the 120 min postprandial incretin response in terms of Glucagon-like Peptide-1 (GLP-1) will be determined. Changes in insulin sensitivity will be determined by the Matsuda-index as appropriate outcome measure.
Interventions
DIETARY_SUPPLEMENTPep2dia
what is the effect of Pep2dia on postprandial glycemia after a meal rich in carbohydrates (75g)
DIETARY_SUPPLEMENTmaltodextrin
maltodextrin
Sponsors
BioTeSys GmbH
Ingredia S.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The study will be performed as a multicentric, randomized, double-blind, and placebo-controlled in a 3-way cross-over design.
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects (minimum one third of each gender) with prediabetic HbA1c values between 5.7% - 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%) * Body mass index 19-35 kg/m2 * Non-smoker * Caucasian * Availability and presence in the study units for approx. 3.5 hours/ week for 3 times. * Signed informed consent form * No changes in food habits or physical activity 3 months prior to screening and during the study
Exclusion criteria
* Presence of disease or drug(s) influencing digestion and absorption of nutrients or bowel habits * Intake of medications known to affect glucose tolerance, e.g., diabetic medication, steroids, protease inhibitors or antipsychotics * Diagnosed Typ 2-Diabetics with medical treatment * 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, renal or cardiac disease * Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks * Known inflammatory and 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 antibiotics within 4 weeks before the test days * Known alcohol abuse or drug abuse * Pregnant or breast feeding women * Known or suspected allergy to any component of the investigational product(s) (e.g. milk protein) * Known HIV-infection * Known acute or chronic hepatitis B and C infection * Blood donation within 4 weeks prior to visit 1 or during the study * Subject unable to co-operate adequately
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose-iAUC(0-180min) | Day 1, Day 15, Day 29 | Area under the curve calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration (according to ISO 26642:2010(E) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Max_increase | Day 1, Day 15, Day 29 | Cmax minus baseline value |
| Tmax | Day 1, Day 15, Day 29 | Time to reach maximum blood glucose concentration |
| Tbaseline | Day 1, Day 15, Day 29 | First time to reach baseline again after increase or decrease in blood glucose |
| Cmax | Day 1, Day 15, Day 29 | Maximum blood glucose concentration |
| Matsuda index | Day 1, Day 15, Day 29 | Marker of insulin sensitivity |
| Increase of insulin | Day 1, Day 15, Day 29 | Area under the curve calculated as the incremental area under the Insulin response curve, ignoring the area beneath the fasting concentration (Insulin-iAUC(0-180min)). If applicable further pharmacokinetic data from insulin increase will be calculated (e.g. Cmax, Tmax) |
| GLP-1-iAUC(0-120min) | Day 1, Day 15, Day 29 | 120 min postprandial incretin response in terms of Glucagon-like Peptide-1 |
| AUC(0-180min) | Day 1, Day 15, Day 29 | Total area under curve from 0 to 180 min for blood glucose concentration |
Countries
Germany
Outcome results
None listed