Type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Outpatients. 2)HbA1c before clinical trial start is 7.0% or more and 8.0% less. 3)Over 20years old. Gender unquestioned. 4)Patients are being treated DPP-4 inhibitor for more than 6 months,and variation of HbA1c by <0.5% whithin 3 months before recruitment. 5)Written informed consent was obtained from all participants.
Exclusion criteria
Exclusion criteria: 1)Type1 diabetic patients and Type2 diabetic patients who depend on insulin. 2)Patients have renal failure (estimated glomerular filtration rate <60mL/min/1.73m2). 3)Patients have severe liver disfunction. 4)Women who may be pregnant, may become pregnant and are breastfeeding. 5)Patients have malignancy or had treated to malignancy past five years. 6)Patients have admission to improve glycemic control within a past year before written consent. 7)Patients are using a drug with the influence for glucose metabolism (steroid, interferon, hormone drugs, antipsychotic drugs and antitubercular drugs). 8)Patients have allergy to protein or dairy product. 9)Patients who were judged to be ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of the HbA1c from baseline in the whey protein supplement performed after each 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of the GA, GLP-1, GIP and PYY from baseline in the whey protein supplement performed after each 12 weeks And the change of body composition by the Bioelectrical Impedance Analysis | — |
Countries
Japan
Contacts
St. Marianna University School of Medicine Division of Metabolism and endocrinology, Depertment of Internal Medicine