Investigation of the effect of isomaltulose (PalatinoseTM) on metabolic parameters in subjects with Type 2 Diabetes.
- Conditions
- Type 2 DiabetesE11.9
- Registration Number
- DRKS00003486
- Lead Sponsor
- Else Kröner-Fresenius-Zentrum für ErnährungsmedizinKlinikum rechts der IsarUptown München Campus D
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 110
written informed consent, sex: female or male, age >18 years, BMI 25 – 40 kg/m2, confirmed type 2 diabetes mellitus, diabetes treatment with diet alone or oral antidiabetic agents (insulin secretagogues, metformin, insulin sensitizers, alpha-glucosidase inhibitors, dipeptidyl peptidase-4 inhibitors) without changes in the therapy regimen for at least three months prior to study start, HbA1c 6.5 – 9.0 % assessed in the screening visit, usual daily intake of 30-60 g sucrose or sucrose equivalent from sweetened foods or beverages assessed by 3-d dietary records before study start, willingness to regular consumption of test products, preference for sweet food in habitual diet,
willingness to restrict intake of sweet foods other than the test products, = 3 meals in the habitual diet
treatment with insulin, presence or history of severe chronic disease, pregnancy and lactation, glucocorticoid therapy, abnormal dietary habits and dislike of sweetened foods.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c after 12 weeks of treatment<br>
- Secondary Outcome Measures
Name Time Method - Parameters of glucose metabolism (fasting glucose, insulin,C-peptide, fructosamine, HOMA-IR): baseline, after 6 and after 12 weeks (by an external laboratory according to standard procedures)<br>- blood lipids (cholesterol, triglycerides): baseline, after 6 and after 12 weeks (by an external laboratory according to standard procedures)<br>- Adipokines (leptin, adiponectin) baseline, after 6 and after 12 weeks (by ELISA)<br>- nutritional intake over the course of the study (baseline, week 4, 6 and 10 by 3 day dietary records)<br>- tolerance/ gastrointestinal parameters: clinical routine parameters (blood count, coagulation, liver enzymes) at baseline, after 6 and after 12 weeks; gastrointestinal parameters and stool characteristics by questionnaires fortnightly over the course of the study<br>- self monitored blood glucose profiles fortnightly over the course of the study (before and 90 min after the three main meals) by a blood glucose meter handed out to the patients<br>