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

Not Applicable

• Conditions: type 2 diabetes mellitus

• Registration Number: JPRN-jRCTs051180050
• Lead Sponsor: Akasaka Hiroshi

Brief Summary

We examined the effect of a combination of glinide and alpha-glucosidase inhibitor on muscle mass and function in older diabetic patients with frailty and postprandial hyperglycemia. However, we cannot conclude from this study because we did not achieve the target number of cases. We decided to terminate this study because we cannot complete the target number due to the transfer of the head of this research, the pandemic of COVID-19, and the other studies targeting similar participants.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-07
• Study Completion: 2020-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 5

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frailty and the indices of sarcopenia (Appendicular muscle mass, grip strength, and gait speed)

Secondary Outcome Measures

Name	Time	Method
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 <br>2) changes of HbA1c and fasting blood glucose level <br>3) changes of the indices of glycemic variability (SD, MAGE, MODD) <br>4) changes of values of comprehensive geriatric assessments (BADL, IADL, Vitality Index, MMSE, GDS, Apathy rating scale(APS), and MNA-SF) <br>5) changes in balancing abilities <br>6) changes of muscle thickness and echo intensity by muscle ultrasonography <br>7) changes in serum concentrations of myokines (IGF-1, IL-6) <br>8) changes in urine concentrations of pentosidine and 8-OhdG <br>9) falls during this investigation <br>10) adverse events and side effects