scholarly journals Can non-responders be ‘rescued’ by increasing exercise intensity? A quasi-experimental trial of individual responses among humans living with pre-diabetes or type 2 diabetes mellitus in Canada

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e044478
Author(s):  
Travis J Hrubeniuk ◽  
Danielle R Bouchard ◽  
Brendon J Gurd ◽  
Martin Sénéchal

IntroductionExercise is recommended to improve glycaemic control. Yet, individual changes in glycaemic control following exercise can vary greatly, meaning while some significantly improve others, coined ‘non-responders’, do not. Increasing the intensity of exercise may ‘rescue’ non-responders and help generate a response to training. This trial will identify non-responders to changes in glycated haemoglobin (HbA1c) across inactive individuals living with pre-diabetes or type 2 diabetes mellitus following an aerobic exercise programme and evaluate if increasing training intensity will elicit beneficial changes to ‘rescue’ previously categorised non-responders.Methods and analysisThis study will recruit 60 participants for a two-phase aerobic exercise training programme. Participants will be allocated to a control group or assigned to an intervention group. Control participants will maintain their current lifestyle habits. During phase 1, intervention participants will complete 16 weeks of aerobic exercise at an intensity of 4.5 metabolic equivalents (METs) for 150 min per week. Participants will then be categorised as responders or non-responders based on the change in HbA1c. For phase 2, participants will be blocked based on responder status and randomly allocated to a maintained intensity, or increased intensity group for 12 weeks. The maintained group will continue to train at 4.5 METs, while the increased intensity group will train at 6.0 METs for 150 min per week.Ethics and disseminationResults will be presented at scientific meetings and submitted to peer-reviewed journals. Publications and presentations related to the study will be authorised and reviewed by all investigators. Findings from this study will be used to provide support for future randomised control trials. All experimental procedures have been approved by the Research Ethics Board at the University of New Brunswick (REB: 2018–168).Trial registration numberNCT03787836.

2018 ◽  
Vol 68 (667) ◽  
pp. e139-e145 ◽  
Author(s):  
Ayorinde F Fayehun ◽  
Olufemi O Olowookere ◽  
Adetola M Ogunbode ◽  
Adedotun A Adetunji ◽  
Arinola Esan

BackgroundIn clinical practice, translating the benefits of a sustained physically active lifestyle on glycaemic control in patients with type 2 diabetes mellitus (T2DM) is difficult. A walking prescription may be an effective alternative.AimTo examine the effect of a 10 000 steps per day prescription on glycaemic control of patients with T2DM.Design and settingForty-six adults with T2DM attending a general outpatient clinic were randomised into two equal groups. The intervention group was given goals to accumulate 10 000 steps per day for 10 weeks, whereas the control group maintained their normal activity habits.MethodDaily step count was measured with waist-mounted pedometer and baseline and endline average steps per day. Glycosylated haemoglobin (HbA1c), anthropometric, and cardiovascular measurements were also obtained. An intention-to-treat analysis was done.ResultsThe average baseline step count was 4505 steps per day for all participants, and the average step count in the intervention group for the last 4 weeks of the study period was higher by 2913 steps per day (95% confidence interval [CI] = 1274 to 4551, F (2, 37.7) = 18.90, P<0.001). Only 6.1% of the intervention group participants achieved the 10 000 steps per day goal. The mean baseline HbA1c was 6.6% (range = 5.3 to 9.0). Endline HbA1c was lower in the intervention group than in the control group (mean difference −0.74%, 95% CI = −1.32 to −0.02, F = 12.92, P = 0.015) after adjusting for baseline HbA1c. There was no change in anthropometric and cardiovascular indices.ConclusionAdherence to 10 000 steps per day prescription is low but may still be associated with improved glycaemic control in T2DM. Motivational strategies for better adherence would improve glycaemic control.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anja Wollny ◽  
Christin Löffler ◽  
Eva Drewelow ◽  
Attila Altiner ◽  
Christian Helbig ◽  
...  

Abstract Background We investigate whether an educational intervention of GPs increases patient-centeredness and perceived shared decision making in the treatment of patients with poorly controlled type 2 diabetes mellitus? Methods We performed a cluster-randomized controlled trial in German primary care. Patients with type 2 diabetes mellitus defined as HbA1c levels ≥ 8.0% (64 mmol/mol) at the time of recruitment (n = 833) from general practitioners (n = 108) were included. Outcome measures included subjective shared decision making (SDM-Q-9; scale from 0 to 45 (high)) and patient-centeredness (PACIC-D; scale from 1 to 5 (high)) as secondary outcomes. Data collection was performed before intervention (baseline, T0), at 6 months (T1), at 12 months (T2), at 18 months (T3), and at 24 months (T4) after baseline. Results Subjective shared decision making decreased in both groups during the course of the study (intervention group: -3.17 between T0 and T4 (95% CI: -4.66, -1.69; p < 0.0001) control group: -2.80 (95% CI: -4.30, -1.30; p = 0.0003)). There were no significant differences between the two groups (-0.37; 95% CI: -2.20, 1.45; p = 0.6847). The intervention's impact on patient-centeredness was minor. Values increased in both groups, but the increase was not statistically significant, nor was the difference between the groups. Conclusions The intervention did not increase patient perceived subjective shared decision making and patient-centeredness in the intervention group as compared to the control group. Effects in both groups might be partially attributed to the Hawthorne-effect. Future trials should focus on patient-based intervention elements to investigate effects on shared decision making and patient-centeredness. Trial registration The trial was registered on March 10th, 2011 at ISRCTN registry under the reference ISRCTN70713571.


2016 ◽  
Vol 26 (2) ◽  
pp. 241-253 ◽  
Author(s):  
Mahdi Moshki ◽  
Atefeh Dehnoalian ◽  
Ali Alami

This study sought to assess the effect of precede–proceed model on preventive behaviors for type 2 diabetes mellitus (DM) in high-risk individuals. In this semi-experimental study, 164 high-risk individuals for type 2 DM were selected and were randomly divided into two groups of intervention and control ( n = 85). Educational intervention was performed as a single session face-to-face instruction for 1.5 hr for the intervention group participants. Data were collected before (baseline) and immediately and 1 month after the intervention in the two groups. The mean score of predisposing (knowledge) factors ( p = .001), reinforcing factors ( p = .001), and enabling factors ( p = .02) were significantly different at baseline and 1 month after the intervention in the intervention group compared with the control group ( p < .05). A significant improvement occurred in the nutritional habits of high-risk participants in the intervention group at 1 month after the intervention compared with controls ( p = .001). The precede–proceed model can be effective for promoting the preventive behaviors for type 2 DM in high-risk individuals.


2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Rezvan Ghafarzadegan ◽  
Javad Javaheri ◽  
Mina Asgari ◽  
Mohammad Golitaleb ◽  
Fatemeh Maraki ◽  
...  

Objectives: The present study aimed to investigate the potential effects of the combined herbal capsule (CHC), as a nutritional supplement, on glycemic indices (GIs) and lipid profile (LP) of patients with type 2 diabetes mellitus (T2DM). Methods: Following a randomized, single-blind, placebo-controlled clinical trial, the current study was conducted on 80 cases with T2DM who were randomly assigned into two groups of treatment (CHCs; n = 40) and control (placebo; n = 40). Both groups received the intervention (500 mg capsules) twice a day for three months, without changes in the previous dose of oral anti-hyperglycemic drugs. The GI and LP levels were measured before the intervention and three months later to investigate the potential efficacy of the interventions. Results: For those in the intervention group, the mean GI [i.e., fasting blood sugar, two hours postprandial (2hpp), and HbA1c] was significantly different after 3 months (P < 0.05). The GI- and LP-related outcomes (TG, LDL-C except for TC) were improved after 3-month of receiving the intervention compared to the control group; however, the observed improvement was no statistically significant (P > 0.05). The HDL-C level was also significantly improved in the intervention group compared to the control group (P < 0.05). Conclusions: This study demonstrated that receiving CHCs could improve GI and LP levels (TG, LDL-C, and HDL-C, except for TC), which indicates its potential to control T2DM. Moreover, no significant side effect was observed in the intervention group. It can be argued that the use of CHCs, as adjuvant therapy, in combination with conventional hypoglycemic and lipid-lowering drugs, as well as following a modified lifestyle, not only can significantly enhance glycemic control but also may prevent T2DM complications.


2020 ◽  
Vol 20 (7) ◽  
pp. 1090-1096
Author(s):  
Yusuf Bozkuş ◽  
Umut Mousa ◽  
Özlem T. İyidir ◽  
Nazlı Kırnap ◽  
Canan Ç. Demir ◽  
...  

Objective: Proton pump inhibitor (PPI) drugs reduce gastric acid secretion and lead to an increase in serum gastrin levels. Many preclinical and some clinical researches have established some positive effects of gastrin or PPI therapy on glucose regulation. The aim of this study was to prospectively investigate the short term effects of esomeprazole on glycaemic control in patients with type 2 diabetes mellitus. In addition, the presence of an association between this effect and gastrin levels was evaluated. Methods: Thirty-two subjects with type 2 diabetes mellitus were enrolled and grouped as intervention (n=16) and control (n=16). The participants in the intervention group were prescribed 40 mg of esomeprazole treatment for three months. At the beginning of the study and at the 3rd month, HbA1c level (%) and gastrin levels (pmol/L) of participants were assessed. Then, the groups were compared in terms of their baseline and 3rd month values. Results: In the intervention group, the mean gastrin level increased significantly from 34.3±14.4 pmol/L to 87.4±43.6 pmol/L (p<0.001). The mean HbA1c level was similar to the pre-treatment level (6.3±0.7% vs. 6.4±0.9%, p=0.441). There were no statistically significant differences in all parameters of the control group. The majority of individuals were on metformin monotherapy (65.6 %). The subgroup analysis of metformin monotherapy revealed that, in intervention group, there was a significant increase in gastrin levels (39.9±12.6 vs. 95.5±52.5, p=0.026), but the HbA1c levels did not change (6.0±0.4 % vs. 5.9±0.6 %, p=0.288); and in control group, gastrin levels did not change (37.5 ± 26.7 vs. 36.1 ±23.3, p=0.367), but there was an increase in HbA1c levels (6.1 ± 0.50 vs. 6.4 ± 0.60, p=0.01). Conclusion: Our study demonstrates that esomeprazole has no extra benefit for the controlled diabetic patient in three months. However, in only the metformin-treated subgroup, esomeprazole may prevent the rise in HbA1c level.


2008 ◽  
Vol 40 (5) ◽  
pp. 779-786 ◽  
Author(s):  
ISABEL C. D. RIBEIRO ◽  
RODRIGO T. IBORRA ◽  
MÔNICA Q. T. S. NEVES ◽  
SIMÃO A. LOTTENBERG ◽  
ANA M. CHARF ◽  
...  

2019 ◽  
Vol 1 (1) ◽  
pp. 80-95
Author(s):  
Rita Fitri Yulita ◽  
Agung Waluyo ◽  
Rohman Azzam

The purpose of this study was to determine the effect of foot exercises on decreasing neuropathy scores and blood sugar levels in patients with type 2 diabetes mellitus. This study used a quasi-experimental design with the Pretest-Posttest Control Group Design approach. The sample in this study consisting of intervention group (n=16) and the control group (n=16). Measurement of neuropathy using Michigan Neuropathy Screening Instrument (MNSI). The statistical test used was the Wilcoxon test, t-dependent test, Mann-Withney test. The results of the study in the intervention group had a significant decrease in neuropathy scores and blood sugar levels (p=0.001). Whereas in the control group there was no significant decrease in neuropathy scores (p=0.069) and blood sugar levels (p=0.184). Based on the Mann-Withney test results showed that there were significant differences in neuropathy scores and blood sugar levels between the intervention group and the control group (p=0.003; p=0.042).The conclusion of this study is that patients with type 2 diabetes mellitus who are given foot gymnastic action have decreased neuropathy scores and blood sugar levels.  Keywords : Foot Exercise, Neuropathy Score, Blood Sugar Level, Michigan Neuropathy Screening Instrument (MNSI), Type 2 DM


2019 ◽  
Vol 18 (5) ◽  
pp. 399-409 ◽  
Author(s):  
Rosario Alonso-Domínguez ◽  
María C Patino-Alonso ◽  
Natalia Sánchez-Aguadero ◽  
Luis García-Ortiz ◽  
Jose I Recio-Rodríguez ◽  
...  

Background: Regular physical activity is essential for metabolic control in type 2 diabetes mellitus. Aims: The aim of this study was to assess the short and long-term impact of a multifactorial intervention on physical activity and clinically relevant biochemical parameters in patients with type 2 diabetes mellitus. Methods: This randomised, controlled clinical trial (NCT02991079) included two parallel groups aged 25–70 years from a primary care health centre in Salamanca, Spain. The subjects were assigned randomly (1:1) to control and intervention groups, using Epidat 4.0 software. Both were counselled on the importance of physical activity and maintaining a healthy diet. The intervention group also took five low–moderate intensity 4 km nurse-guided walks, received a smartphone application to promote healthy habits and attended a diet workshop. Physical activity was measured objectively using a pedometer and subjectively using a shortened international physical activity questionnaire (at baseline, 3 and 12 months). Results: In total, 204 subjects were included (mean age 60.6 years, 45.6% were women). After 3 months, relative to the control group, the intervention group increased their daily number of steps by 1852, aerobic steps by 1623, distance walked by 994 m, and total metabolic equivalent minutes per week by 1297 and decreased sedentary time by 34.3 minutes per day. Differences from baseline persisted at 12 months, including mean increases of 1141 daily steps, 917 aerobic steps, and 1065 total metabolic equivalent minutes per week in the intervention group relative to the control group ( P<0.05 for all). Conclusions: The success of this multifactorial intervention should help inform future clinical approaches and application designs towards managing type 2 diabetes mellitus and improving patient outcomes.


Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Emi Ushigome ◽  
Chikako Oyabu ◽  
Makoto Shiraishi ◽  
Nobuko Kitagawa ◽  
Aya Kitae ◽  
...  

Abstract Background Hypertension is present in more than 50% of patients with type 2 diabetes mellitus. Dietary salt restriction is recommended for the management of high blood pressure. Instructions on dietary salt restriction, provided by a dietitian, have been shown to help patients reduce their salt intake. However, appointments for the dietitians in hospitals are often already fully booked, making it difficult for patients to receive instructions on the same day as the outpatient clinic visit. Aim The aim of this trial is to test a new intervention to assess whether guidance on dietary salt restriction provided by physicians during outpatient visits is effective in reducing salt intake in patients with type 2 diabetes mellitus who have an excessive salt intake. Methods In this unblinded randomized controlled trial (RCT), a total of 200 patients, male or female, aged between 20 and 90 years, who have type 2 diabetes mellitus and consume excessive salt will be randomly assigned to two groups: an intervention group and a control group. In addition to being given routine treatment, participants in the intervention group will be given individual guidance on restricting their dietary salt intake by a physician upon enrollment. The control group will only be given routine treatment. Participants will be followed up for 24 weeks. The primary outcome will be dietary salt intake, which will be assessed at baseline and at 8, 16, and 24 weeks. The secondary outcomes, including body weight, body mass index, hemoglobin A1c level, blood pressure, blood glucose level, serum lipid profile, and urinary albumin excretion level, will be assessed at baseline and at 8, 16, and 24 weeks. Discussion The results of this RCT have the potential to provide a simple and novel clinical approach to reduce salt intake among patients with type 2 diabetes, making regular visits to their physician, in outpatient facilities. This protocol will contribute to the literature because it describes a practical intervention that has not been tested previously, and it may serve as guidance to other researchers interested in testing similar interventions. Trial registration University Hospital Medical Information Network (UMIN), UMIN000028809. Registered retrospectively on 24 August 2017. http://www.umin.ac.jp.


Sign in / Sign up

Export Citation Format

Share Document