Clinical study to assess the long-term effect of a mixture ofplant extracts on glucose homeostasis in prediabetic subjects: a 12-week randomized, double-blind, placebo-controlled, parallel study

Not Applicable

Recruiting

• Conditions: prediabetes; R73.9; Hyperglycaemia, unspecified

• Registration Number: DRKS00034041
• Lead Sponsor: APOMEDICA Pharmazeutische Produkte GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Main inclusion criteria:
- Male and female subjects with prediabetic HbA1c values between 5.7% – 6.4% and/or fasting glucose = 5.6 mmol/L (= 100 mg/dL) and = 6.9 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
- Current Non-smoker
- 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

Main Exlusion criteria:
- Diagnosed type 2 diabetes mellitus 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
- Known inflammatory and malignant gastrointestinal diseases (i.e. colitis ulcerosa, Morbus Crohn, celiac disease, malignant diseases e.g. colon-cancer, rectum cancer, pancreatitis)
- 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
- Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs
- Intake of food supplements known to affect glucose tolerance, e.g. cinnamon capsules, conjugated linoleic acids within 4 weeks prior to Visit 1 or during the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting blood glucose (baseline, after 6 and 12 weeks)

Secondary Outcome Measures

Name	Time	Method
•Glycated haemoglobin (HbA1c) ((baseline and 12 weeks)<br>•HOMA-index (baseline, after 6 and 12 weeks)<br>•Fasting insulin (baseline, after 6 and 12 weeks)<br>•Capillary fasting blood glucose measurements (home-based; 3 x 1 week; Baseline, week 6 and week 12)<br>•Blood lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) (baseline, after 6 and 12 weeks)<br>•Sagittal abdominal diameter (SAD) intervention (Baseline, after 6 and 12 weeks)<br>•Body weight (baseline, after 6 and 12 weeks)<br>•Quality of life questionnaire (SF-12) (baseline and 12 weeks)<br>•hsCRP (acute phase protein) (baseline, after 6 and 12 weeks)<br><br>Subgroup (n=28, randomized(1:1)) additional measurement (baseline and after 12 weeks): : <br>•postprandial assessment of blood glucose increase after intake of a carbohydrate meal: iAUC0-180 min, Delta Cmax, Tmax<br>•Insulin sensitivity index ISI0-120 min<br>•2h glucose value after mixed meal