Are glucose levels, glucose variability and autonomic control influenced by inspiratory muscle exercise in patients with type 2 diabetes? Study protocol for a randomized controlled trial

Abstract

BackgroundPhysical exercise reduces glucose levels and glucose variability in patients with type 2 diabetes. Acute inspiratory muscle exercise has been shown to reduce these parameters in a small group of patients with type 2 diabetes, but these results have yet to be confirmed in a well-designed study. The aim of this study is to investigate the effect of acute inspiratory muscle exercise on glucose levels, glucose variability, and cardiovascular autonomic function in patients with type 2 diabetes.Methods/designThis study will use a randomized clinical trial crossover design. A total of 14 subjects will be recruited and randomly allocated to two groups to perform acute inspiratory muscle loading at 2 % of maximal inspiratory pressure (PImax, placebo load) or 60 % of PImax (experimental load).DiscussionInspiratory muscle training could be a novel exercise modality to be used to decrease glucose levels and glucose variability.Trial registrationClinicalTrials.gov NCT02292810.

Glycemic variability: adverse clinical outcomes and how to improve it?

“…Patients with type 1 diabetes CGM Reduced GV and improved protection against hypoglycemia [87][88][89] Insulin analogues degludec Minimized morning GV [91] Canagliflozin Improved indices of GV [92] Dapagliflozin over 24 weeks Improved GV without increasing the time spent in the range indicating hypoglycemia [93] Empagliflozin as adjunct to insulin Decreased glucose exposure and variability and increased time in glucose target range [103] Combination of basal insulin with ipragliflozin or dapagliflozin Improved TIR and the mean glucose level [104] Low carbohydrate diet Resulted in more time in euglycemia, less time in hypoglycemia [108][109][110] Patients with type 2 diabetes Dapagliflozin on 24-h Improved measures of GV [94] Once-weekly trelagliptin and once-daily alogliptin Improved glycemic control and reduced GV without inducing hypoglycemia [95] Combination of basal insulin with a GLP-1 RA Lowered GV and hypoglycemia [96] Exenatide once weekly Improved daily glucose control and reduced GV [97] Lixisenatide added to basal insulin Reduced GV and PPG excursions without increasing the risk of hypoglycemia [98] Liraglutide Lower mean time in hyperglycemia [99] Combination of metformin and gemigliptin or sitagliptin Significantly reduced GV [100] Vildagliptin or pioglitazone Significantly reduced MAGE, glycated hemoglobin and mean plasma glucose levels [101] Combination of metformin and vildagliptin or glimepiride Improved glucose level with a significantly greater reduction in GV and hypoglycemia [102] Intensive insulin therapy combined with metformin Reduced both glucose fluctuation and nocturnal hypoglycemic risk [105] Low-carbohydrate high-fat diet Reduced glycemic fluctuation [106,107,111] Sequence of food ingestion Associated with lower post-lunch glucose excursions and lower glucose coefficients of variation [115] Aerobic and combined exercise sessions Reduced glucose levels and GV [116][117][118] Short-term exercise training Improved glycemic control and GV but unaffected oxidative stress…”

“…There is evidence that different types of exercise have various effects on glucose control. Schein et al performed a randomized clinical trial and found that inspiratory muscle training decreased glucose levels and GV in patients with type 2 diabetes, which could be a novel exercise modality [118]. Another crossover trial showed that short-term interval walking training improved CGM-derived GV compared with continuous walking training in individuals with type 2 diabetes [119].…”

Physical Exercise Improves Glycemic and Inflammatory Profile and Attenuates Progression of Periodontitis in Diabetic Rats (HFD/STZ)

“…Improvement in glycaemia and HbA1c with exercise is a commonly reported result [ 36 , 37 ]. Physical exercise is one of the most recommended non-pharmacological strategies for glycemic control in individuals with DM [ 38 ].…”

Acute inspiratory muscle exercise effect on glucose levels, glucose variability and autonomic control in patients with type 2 diabetes: A crossover randomized trial

“…This is a double blind crossover randomized clinical trial previously described in detail (Schein et al, 2016). Patients with type 2 DM were recruited from the Endocrinology Outpatient Clinic at Hospital de Clínicas de Porto Alegre (HCPA), Brazil and through website posting.…”