Effect of different milk fractions on the metabolic response in healthy and prediabetic volunteers
- Conditions
- glucose homeostasis
- Registration Number
- DRKS00005682
- Lead Sponsor
- Kraft Foods R&D Inc.Zweigniederlassung München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 42
Inclusion criteria for healthy volunteers:
-age between 20 and 50 years -BMI 20 up to 28 kg/m2 -written consent
Inclusion criteria for prediabetic volunteers:
-age between 20 and 50 years -confirmation of the prediabetic state corresponding to the definition of the WHO. ( Glucose tolerance test: baseline/fasting state = 6,1 mmol/l (= 110 mg/dl) and < 7,0 mmol/l (< 126 mg/dl) in venous plasma or = 5,6 mmol/l (= 100 mg/dl) and < 6,0 mmol/l (< 109 mg/dl) in capillary whole blood and/or 2 hour sample = 7,8 mmol/l (= 140 mg/dl) and <11,1 mmol/l (< 200 mg/dl) in venous plasma or capillary whole blood -written consent
Inclusion criteria for diabetic patients:
-age up to 74 years -single Metformin therapy -written consent
Exclusion criteriy for healthy volunteers:
-chronic diseases e.g. diabetes mellitus, inflammatory diseases, cardiovaskular diseases, infectious diseases
-severe depression
-known drug- and alcoholabuse
-medication
-smoker
Exclusion criteria for prediabetic volunteers:
-chronic diseases e.g.iinflammatory diseases, cardiovaskular diseases, infectious diseases
-severe depression
-known drug- and alcoholabuse
-medication
-smoker
Exclusion criteria for diabetic patients:
-severe depression
-known drug- and alcoholabuse
-smoker
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hemocue: glucose <br>Multiplex: insulin,GIP, C-peptides, glucagon <br>Elisa: GLP-1 <br><br>time span: up to 240 min after intake in the fasting state<br><br>reading points: 0, 15, 30, 45, 60, 90, 120, 180, and 240 min
- Secondary Outcome Measures
Name Time Method C-MS/MS: acetaminophen, amino acids, acylcarnitine <br>Multiplex: ghrelin <br>Spectrometer: superoxiddismutase, catalase, glutathionreductase, dipeptidylpeptidase IV, ß-hydroxybutyrate, non esterified free fatty acids <br>visual analogue scale feeling of hunger<br><br>time span: up to 240 min after intake in the fasting state<br><br>reading points: 0, 15, 30, 45, 60, 90, 120, 180, and 240 min<br>reading points for visual analogue scale: every 30 min<br>reading points forSOD, catalase, glutathione reductase: 0, 30, 240 min<br>