Type2 Diabetes mellitus Dyslipidemia Hypertension
Conditions
Interventions
[Low-carbohydrate(LCD50g)group] Total calorie is designed according to ideal BMI and indivisual activity,and kept until study ends. 0-8w(LCD 50g period):Carbohydrate is restricted and participants
choice(no food offer),keeping 120g of carbohydrates per day. well trained dietitians check food content everyday.
[Low-carbohydrate(LCD120g)group] Total calorie is designed according to
choice(no food offer),keeping 120g of carbohydrates per day. well trained dietitians check food content everyday.
Sponsors
The Institute for Adult Diseases,Asahi Life Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a)25<=BMI<35 b)Patients with Type2 diabetes,dyslipidemia,or hypertension. c)HbA1c<=8.5% d)Patients receiving certain diet and exercise therapy continuously from at least 4 weeks prior to the start of intervention. e)Patients not taking medications in period from at least 4 weeks prior to the start of intervention,or taking same-dose medications continuously from at least 4 weeks prior to the start of intervention. f)Patients who have been explained details of the study,understood them,and given written informed consent for participation.
Exclusion criteria
Exclusion criteria: a)Patients taking SGLT2 inhibitor b)Patients who have severe food allergy c)Pregnant woman,breast-feeding women and expectants. d)Patients with diabetic nephropathy of stage3,4,5. e)Patients with serious hepatic dysfunction. f)Patients with serious hepatic diseases such as hepatitis. g)sBP>=150mmHg or dBP>=100mmHg h)Patients with history of cerebral or cardiovascular events such as cerebral infarction or miocardial infarction or severe congestive heart failure within 90 days prior to the start of intervention. i)Patients with unstable diabetic retinopathy. j)Patients with malignant tumors (those who are currently receiving no treatment and had no recurrense, and those considered unlikely to have any recurrense during the study period are eligible for the study) k)Patients with severe mental disorders. l)Patients deemed unsuitable for participation in the study by the investigator due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Every month after intervention,body weight,blood pressure,body composition will be assessed. 2,3 month after intervention,HbA1c,FPG,serum keton body,kidney and liver function and lipid profile will be checked. C-peptide,urinary albumin,PWV/ABI will be checked at last visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the differences between LCD 50g and LCD 120g by assessing parameters. | — |
Countries
Japan
Contacts
Public ContactCHIEKO KASHIWADO
Rizap Medical Division
Outcome results
None listed