The beneficial effect of improvement of postprandial hyperglycemia on frailty or sarcopenia

JRCT ID: jRCTs051180050

Registered date:07/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: type 2 diabetes mellitus
• Date of first enrollment: 22/03/2018
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Glubes combination tablet, 3times a day just before every meal)
Amaryl 0.5mg or Glimicron HA 20mg, once a day before breakfast

Outcome(s)

• Primary Outcome: Frailty and the indices of sarcopenia (Appendicular muscle mass, grip strength, and gait speed)

Secondary Outcome

1) the relationship between frailty and the indices of glycemic variability (SD, MAGE(Mean Amplitude Glycemic Excursions), MODD (Mean of Daily Difference of Blood Glucose)) and the indices of sarcopenia at baseline
2) changes of HbA1c and fasting blood glucose level
3) changes of the indices of glycemic variability (SD, MAGE, MODD)
4) changes of values of comprehensive geriatric assessments (BADL, IADL, Vitality Index, MMSE, GDS, Apathy rating scale(APS), and MNA-SF)
5) changes in balancing abilities
6) changes of muscle thickness and echo intensity by muscle ultrasonography
7) changes in serum concentrations of myokines (IGF-1, IL-6)
8) changes in urine concentrations of pentosidine and 8-OhdG
9) falls during this investigation
10) adverse events and side effects

Key inclusion & exclusion criteria

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

Include criteria

1) the subjects aged 65 years or older with type 2 diabetes treated with DPP-4 inhibitors or GLP-1 analogs
2) the subjects diagnosed as 'pre-frailty' by CHS classification of frailty
3) the subjects treated without or can stop treatment with the drugs as follows: sulfonylureas, glinides, alpha-glucosidases, and rapid-acting insulins
4) the subjects with 200mg/dl or over of adlib blood glucose level (>twice a week)
5) the subjects that an agreement was provided in a document

Exclude criteria

1) the subjects with type 1 diabetes
2) the subjects with HbA1c less than 7.5%
3) the subjects with uncontrolled hypertension (SBP >= 160mmHg)
4) the subjects with effort angina, chronic heart failure, and tachyarrhythmia
5) the subjects with chronic respiratory failure
6) the subjects not able to walk by themselves
7) the subjects with chronic kidney disease
8) the subjects with severe hepatic dysfunction
9) the subjects not preserved basic ADL and instrumental ADL
10) the subjects with cognitive impairment
11) the subjects with gastrointestinal surgery
12) the subjects participating other clinical investigations
13) the subjects who are judged by the investigators to be not suitable for participation in the study

Related Information

• Primary Sponsor: Akasaka Hiroshi
• Source(s) of Monetary Support: Kissei Pharmaceutical Co., Ltd.,Kissei Pharmaceutical Co., Ltd.
• Secondary ID(s): UMIN000030766