Type 2 diabetes
Conditions
Interventions
Diet and exercise therapy group The first day(D0), doctor'
s hearing, meal tolerance test and installation of CGM are implemented. During a ingestion period, ingest 2 packs of white rice a day (D1 to D5), then ingest 2 packs of barley mixed rice a day (D6 to
Sponsors
Nakakinen Clinic Medical corporation kensei-kai
Faculty of Life and Environmental Sciences,University of Yamanashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Type 2 diabetic patients who satisfy one of the following conditions. A) Those who are treated with diet / exercise only. B) In addition to diet / exercise therapy, those taking alpha-GI (acarbose). C) In addition to diet / exercise therapy, those taking metformin. Those taking acarbose or metformin should not change the dosage more than 60 days before D0. (2) Persons whose HbA1c are 6.5 to 8.5% (when obtaining consent). (3) Persons who are over 20 years old. (4) Persons who obtained consent.
Exclusion criteria
Exclusion criteria: (1) Serious ketosis, diabetic coma or precoma, patients with dialysis and type 1 diabetic patients. (2) Patients with diseases or trauma such as serious infection, before and after surgery, cancer, etc. (3) Those who are taking hypoglycemic drugs except the drugs listed in the selection criteria. (4) Persons who merged gastrointestinal disorders affecting digestion / absorption. (5) Persons who have a medical history of gastrointestinal resection. (6) Persons who merged serious liver and kidney problems (as judged by a doctor). (7) Persons who developed myocardial infarction / stroke within 180 days before D0. (8) Persons who take systemic steroids (excluding local). (9) Smokers. (10) Persons who are drinking excessively (For example, 180 mL or more of sake per day, three or more big bottles of beer per day). (11) Persons who have a history of hypersensitivity (food allergy etc.) to the test meals (barley, rice, wheat, milk ingredients, apples, beef, pork, soybeans and sesame). (12) Persons who usually consume barley. (13) Pregnant women or ladies who may be pregnant. (14) Others who are judged inappropriate by the representative doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose (0, 30, 60, 90, 120 min) | — |
Secondary
| Measure | Time frame |
|---|---|
| CGM Data Insulin (0, 30, 60, 90, 120 min) Inflammation related factor (0, 120 min) Incretin (0, 30, 60, 120 min) Feeding hormone (0, 30, 60, 120 min) Safety data: Weight, BMI Blood pressure measurement General biochemical test Blood cell test Questionnaire: Advance questionnaire Questionnaire(Test day) Diet survey form | — |
Countries
Japan
Contacts
Public ContactKensuke Ofuchi
Nakakinen Clinic Medical corporation kensei-kai Department of clinical research
Outcome results
None listed