The glycemic effect of post-meal walking with basal insulin compared to basal plus regimen in type 2 diabetes: a Randomized controlled cross-over study

Not Applicable

Completed

• Conditions: glycemic controlled; post- meal walking

• Registration Number: TCTR20170419003
• Lead Sponsor: Ramathibodi hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-19
• Study Completion: 2018-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

- type 2 diabetes with at least 2 oral hypoglycemic drugs
- FPG < 150 mg/dL for 2 consecutive blood test before enrollment
- No adjustment of basal insulin or oral hypoglycemic drugs for 3 months
- HbA1c 7-9%
- BMI 18.5-30 kg /m2
- Eligible participant

Exclusion Criteria

- Severe uncontrolled hypertension (SBP > 160 mmHg or DBP > 100 mmHg)
- Acute myocardial infarction or cerebrovascular disease in 6 months
- Functional status class II
- musculoskeletal problem that affected walking
- Visual problem that affected walking
- Decrease pinprick sensation or other diabetic neuropathy
- History of severe diabetic foot ulcer / history of amputation
- treatment with systemic corticosteroid
- history of drug abuse
- drinking alcohol more than 7 drinks per week
- night shift
- on premixed or basal bolus insulin
- on GLP-1 agonist
- on alpha-glucosidase inhibitor
- the subjects denied to participate in trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c at 0 and 6 weeks blood test, Turbidimetric inhibition immunoassay

Secondary Outcome Measures

Name	Time	Method
serum fructosamine 0,3,6 week blood test, chemiluminescence,2-hour mean PPPG every meal / day, once a week, total 6 weeks capillary blood glucose,24-hour mean plasma glucose premeal and 2 hour postpandrial every meal, once a week, total 6 weeks capillary blood glucose,postpandrial plasma glucose 1,2,3, and 4 hours after standardized meal at 0 and 6 weeks blood test, Hexokinase/Glucose-6-Phosphate Dehydrogenase (HK/G6P-DH) ,Triglyceride 1,2,3, and 4 hours after standardized meal at 0 and 6 weeks blood test, accelerator selective dependent method ,Hypoglycemia event N/A History of symptom and capillary blood glucose during symptom,Weight, waist circumference and BMI 0 and 6 weeks measure by investigator