Effects of SGLT2 inhibitors on appetite in patients with type 2 diabetes

JRCT ID: jRCT1050220190

Registered date:14/03/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 14/03/2023
• Target sample size: 58
• Study type: Observational

Outcome(s)

Primary Outcome

1) Mean difference in fasting plasma glucose at 24 weeks and at the start of SGLT2 inhibitor
2) Mean difference in total score on the Japanese version of the Power of Food Scale between the start of SGLT2 inhibitor and the 24-week time point

Secondary Outcome

1) Mean difference in body weight at start of SGLT2 inhibitor and at 24 weeks
2) Mean difference in HbA1c between starting SGLT2 inhibitor and 24 weeks
3) Difference in ketone body fraction between starting SGLT2 inhibitor and at 24 weeks
4) Mean difference in calorie intake per day between starting SGLT2 inhibitor and at 24 weeks
5) Mean difference in daily carbohydrate intake between starting SGLT2 inhibitors and at 24 weeks
6) Mean difference in protein intake per day between starting SGLT2 inhibitors and at 24 weeks
7) Mean difference in lipid intake per day between starting SGLT2 inhibitors and at 24 weeks
8) Mean difference in the total score of the Food Craving Inventory for Japanese psychological scale between the start of SGLT2 inhibitor and at 24 weeks
9) Free response on whether there was any change in dietary habits between the start of SGLT2 inhibitors and the 24-week point in time.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1) Those with a diagnosis of type 2 diabetes
2) Persons starting SGLT2 inhibitors
3) Patients between 20 and 85 years of age
4) Patients with renal function eGFR 30 or higher
5) BMI of 18.5 or more

Exclude criteria

1) Those undergoing treatment for cancer
2) Pregnant women
3) Those who are emotionally unstable due to mental illness, etc. and have difficulty participating in the research
4) Those who have difficulty in reading and understanding Japanese
5) Persons with dementia
6) Those who are judged by the attending physician or researcher to be unable to participate in the research.

Related Information

• Primary Sponsor: Nin Kazuko