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

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20170419003
• Date of registration: 19/04/2017
• Prospective Registration: Yes
• Primary sponsor: Ramathibodi hospital
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 25/04/2017
• Target sample size: 16
• Recruitment status: Completed
• URL: https://www.thaiclinicaltrials.org/show/TCTR20170419003
• Study type: Interventional
• Study design: Randomized
• Phase: N/A

Countries of recruitment

Thailand

Contacts

• Name: Onnicha Suntornlohanakul
• Affiliation: Ramathibodi hospital

• Name: Onnicha Suntornlohanakul
• Affiliation: Ramathibodi hospital

Key inclusion & exclusion criteria

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

Age minimum: 35 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

glycemic controlled
post-meal walking
glycemic controlled

post-meal walking
glycemic controlled

Intervention(s)

Experimental Behavioral,Active Comparator Drug

post-meal walking with basal insulin,basal plus regimen

- The subjects must walk after the heaviest meal of the day for 15-20 minutes at least 1 meal / day, everyday for 6 weeks
- The subjects have to continue their basal insulin in the same dose,- The subjects have to use bolus insulin (rapid acting insulin) before the heaviest meal of the day every day
- The subjects have to continue their basal insulin in the same dose

Primary Outcome(s)

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

Secondary Outcome(s)

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

Source(s) of Monetary Support

none

Ethics review

Status: Submitted, approved
Approval date:
Contact:

[e-mail]

Mahidol university

022011544 Ext.

[e-mail]

Results

• Date Completed: 31/01/2018