Bestimmung der stimulierten ß-Zell-Kapazität im oralen Nateglinide 50 g Glukose-Toleranz-Test - „Nateglinide-Test
- Conditions
- on-insulin demanding type 2 diabetes
- Registration Number
- EUCTR2006-006384-24-DE
- Lead Sponsor
- Johan Wolfgang Goethe Universität - Department of Internal medicine I, Division Endocrinology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Typ 2 Diabetes, male or female
Age 18 – 80 years
Control:
young, healthy volunteers
no diabetes, IFG or IGT stated in the case history
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Active, consuming diseases (cancer, HIV)
Renal failure (creatinine >1,5 mg/dl)
Liver diseases (AST, ALT >1,5x ULN)
Psychiatric diseases
Insulin therapy
Pregnancy or missing contraception in childbearing ange, nursing
contraindication to Nateglinide
Typ 1 diabetes
Unable or unwilling to comply with study
Maltose-Malabsorption
acut gastrointestinal infection
gut surgery in the case history
fever
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of the ß-cell-secretory-capacity by giving 120 mg Nateglinide and 50 g glucose in individuals with type 2 diabetes in a modyfied oral glucose tolerance test.;Secondary Objective: Classification of patients with type 2 diabetes;Primary end point(s): glucose, Insulin, C-peptide<br>- AUC, <br>- max. level and time of max. level<br>Insulin resistence: HOMA-IR, QUICKI, ISI<br>
- Secondary Outcome Measures
Name Time Method