DRKS00034041
Recruiting
未知
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- prediabetes
- Sponsor
- APOMEDICA Pharmazeutische Produkte GmbH
- Enrollment
- 42
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
A clinical study for evaluating of the effect of a supplement containing plant extract on the gut microbiome. -A Randomized, Double-blind, Placebo controlled, parallel-group StudyHealthy subjects with a tendency for constipationJPRN-UMIN000047224FUKUOKA KINEN PET KENSHIN CENTER30
Completed
Not Applicable
A clinical study for evaluating of the effect of a complex food on postprandial serum triglyceride.JPRN-UMIN000029484Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital40
Completed
Not Applicable
A clinical study for evaluating the effects of the combined administration of L-citrulline and L-arginine on blood arginine and NOx levelsoneJPRN-UMIN000016647Soiken Inc.40
Completed
Not Applicable
A prospective Longitudinal trial of the effect of Atomoxetine on cognitive, educational, behavioural, social and emotional wellbeing in students with Attention Deficit Hyperactivity DisorderAttention Deficit Hyperactivity DisorderMental and Behavioural DisordersBehavioural and emotional disordersISRCTN05214203Australian Research Council (Australia)144
Recruiting
Phase 4
An observation study on the long-term efficacy of Huisheng oral solution after radical operation of stage II to IIIb non-small cell lung cancer (NSCLC)on-small cell lung cancer(NSCLC)ITMCTR2100004907Sichuan Provincial People's Hospital