Type 2 Diabetes E11.9
Conditions
Interventions
Group 1: 50 g per day sucrose by sweet foods and beverages over a period of 12 weeks
Group 2: 50 g per day isomaltulose by sweet foods and beverages over a period of 12 weeks
Sponsors
Else Kröner-Fresenius-Zentrum für Ernährungsmedizin
Klinikum rechts der Isar
Uptown München Campus D
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: treatment with insulin, presence or history of severe chronic disease, pregnancy and lactation, glucocorticoid therapy, abnormal dietary habits and dislike of sweetened foods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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) - blood lipids (cholesterol, triglycerides): baseline, after 6 and after 12 weeks (by an external laboratory according to standard procedures) - Adipokines (leptin, adiponectin) baseline, after 6 and after 12 weeks (by ELISA) - nutritional intake over the course of the study (baseline, week 4, 6 and 10 by 3 day dietary records) - 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 - 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 | — |
Countries
Germany
Contacts
Public ContactStefanie Brunner
Else Kröner-Fresenius-Zentrum für Ernährungsmedizin Klinikum rechts der Isar Uptown München Campus D
Outcome results
None listed