Efficacy of sarcopenia treatment in patients with type 2 diabetes mellitus

JRCT ID: jRCTs041240108

Registered date:18/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 18/10/2024
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Drug Therapy
(1) Lotriga Granular Capsules 2g once a day, immediately after meals
(2) Leebact granules: 3 times a day, after meals
Exercise Therapy
Twice a week, approximately 55 minutes of outpatient rehabilitation will be provided. The content of the exercise is as follows,
(1) Exercise using a chair (20 minutes)
(2) Upper and lower limb strength training using a strength training machine (30 minutes)
(3) Upper and lower limb stretching (5 minutes)

Outcome(s)

• Primary Outcome: Change in skeletal muscle index

Secondary Outcome

Amount of change in the following items before and after protocol treatment
Body weight, BMI
Blood pressure, pulse rate
GOT, GPT, TP, ALB, T-chol, TG, LDL-chol, HDL-chol, BUN, Cre, HbA1c, glycoalbumin, Cre/cystatin C ratio, ferritin, NT-ProBNP, lipoprotein(a), carnitine, TRACP-5b in blood tests, BAP, somatomedin C
TIR/TAR/TBR by FreeStyle Libre
SF-36 Questionnaire, Cognitive and Life Functioning Questionnaire (DASC-8), EAT-10 (swallowing screening tool), Questionnaire on Stages of Behavior Change (exercise items only)
Grip strength, chair stand test, TUG (Timed Up and Go) test
ABI, baPWV
T2 relaxation time of mediobasal hypothalamus, putamen, and amygdala in head MRI

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients 65 years of age or older at the date of enrollment
2) Patients who meet the following sarcopenia diagnostic criteria (based on AWGS2019)
Grip strength: 28 kg or less in men and 18 kg or less in women
SMI (musculoskeletal index) measured by InBody: 7.0 kg/m2 or less in men and 5.4 kg/m2 or less in women.
3) Patients whose blood samples taken within 2 weeks prior to enrollment meet the following criteria
8.0% > HbA1c > 6.5
4) Patients who provide written consent for participation in the study

Exclude criteria

1) Patients with hyperglycemic emergencies, severe infections, major surgeries, or serious trauma within the past 6 months
2) Patients scheduled for surgery within the next 3 months
3) Patients who have already received prescriptions for EPA, EPA/DHA, or BCAA preparations
4) Patients with a history of allergy to EPA, EPA/DHA, or BCAA preparations in the past
5) Patients with bleeding (blood disease, active gastrointestinal ulcer, vitreous hemorrhage, etc.)
6) Patients with inborn errors of metabolism of branched-chain amino acids
7) Patients who are judged to be inappropriate as research subjects by the investigator(s), such as those who have difficulty in outpatient visits, those who are unlikely to be able to receive a certain intensity of rehabilitation.

Related Information

• Primary Sponsor: KOYAMA HIROYUKI