Weight management impact of "asken medical system" in patients with type 2 diabetes.

JRCT ID: jRCTs052210213

Registered date:30/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 27/05/2022
• Target sample size: 62
• Study type: Interventional
• Intervention(s): Medical nutrition therapy with "asken medical system"

Outcome(s)

• Primary Outcome: Body weight reduction (%) at 12 weeks

Secondary Outcome

1) Body weight reduction (%) at 24 weeks
2) Change of clinical data (HbA1c, glycated albumin, LDL, HDL, urine Na, urine K)
3) Change of dietary intake
4) Change of dietary behavior
5) Chane of adherence score
6) Change of diabetes distress
7) Change of blood pressure
8) Optimization of medical nutrition therapy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Type 2 diabetes
2) Diabetic nephropathy stage 1 or 2
3) Aged 20 y.o. or older
4) BMI >= 25
5) HbA1c >= 6.5%
6) Mobile device user
7) Written informed consent

Exclude criteria

1) Using application assessing dietary intake
2) Pregnant or suspected to be pregnant
3) Breastfeeding
4) Less than 84 days after diagnosed with diabetes
5) Continuous administration of steroids
6) eGFR < 45ml/min/1.73cm2
7) Chronic pancreatitis or pancreatic cancer
8) Liver cirrhosis
9) Decompensated heart failure
10) Drug or alcohol dependence
11) Unstable mental disease
12) Malignant tumor
13) Comorbidity affecting primary outcome
14) Inappropriate for inclusion in the study

Related Information

• Primary Sponsor: Ikeda Kaori
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development