scholarly journals Effects of meal replacement therapy on metabolic outcomes in Thai patients with type 2 diabetes: A randomized controlled trial

2018 ◽  
Vol 24 (4) ◽  
pp. 261-268
Author(s):  
Apussanee Boonyavarakul ◽  
Rattana Leelawattana ◽  
Chatlert Pongchaiyakul ◽  
Supawan Buranapin ◽  
Pariya Phanachet ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Total Cholesterol ◽  
Controlled Trial ◽  
Control Group ◽  
Meal Replacement ◽  
Randomized Controlled ◽  
Metabolic Outcomes ◽  
Significant Difference

Background: A meal replacement (MR) with a low glycemic index (GI) is possibly beneficial for glycemic control. However, the effects of MR on diabetes mellitus have not been studied among Thai patients with type 2 diabetes (T2DM). Aim: To compare metabolic outcomes between T2DM patients receiving the new MR formula (ONCE PRO) and normal controlled diets. Methods: A multicenter, open-labeled, randomized controlled trial was conducted. Eligible patients received either ONCE PRO for one meal daily with controlled diets or only controlled diets for 3 months. The differences in metabolic profile between the baseline and end point of each group and between groups were measured. Results: 110 participants were enrolled; the mean difference and standard deviation in hemoglobin A1C (HbA1c) (%) from baseline were –0.21 ± 0.78 ( p = 0.060) and –0.27 ± 0.60 ( p = 0.001) in the MR and control groups, respectively; however, there was no significant difference between groups ( p = 0.637). Patients consuming a MR instead of breakfast had a significant decrease in HbA1c ( p = 0.040). Body weight (BW) and body mass index (BMI) were significantly reduced in both groups. There were no significant change in waist circumference, fasting plasma glucose, total cholesterol and triglycerides. Low-density lipoprotein cholesterol (LDL-C) was significantly decreased in the MR group compared with the control group ( p = 0.049). Conclusions: Short-term conventional diet control and the low-GI MR product were associated with a decreased BW and BMI. Changes in the other metabolic outcomes, HbA1c, total cholesterol and triglycerides, were comparable despite ONCE PRO as the MR having a better effect on LDL-C lowering.

scholarly journals Impact of combined training with different exercise intensities on inflammatory and lipid markers in type 2 diabetes: a secondary analysis from a 1-year randomized controlled trial

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
João P. Magalhães ◽  
Diana A. Santos ◽  
Inês R. Correia ◽  
Megan Hetherington-Rauth ◽  
Rogério Ribeiro ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Lipid Profile ◽  
Total Cholesterol ◽  
Controlled Trial ◽  
Soluble Form ◽  
Randomized Controlled ◽  
Lipid Markers ◽  
Inflammatory Profile

Abstract Background Exercise is a well-accepted strategy to improve lipid and inflammatory profile in individuals with type 2 diabetes (T2DM). However, the exercise intensity having the most benefits on lipids and inflammatory markers in patients with T2DM remains unclear. We aimed to analyse the impact of a 1-year combined high-intensity interval training (HIIT) with resistance training (RT), and a moderate continuous training (MCT) with RT on inflammatory and lipid profile in individuals with T2DM. Methods Individuals with T2DM (n = 80, aged 59 years) performed a 1-year randomized controlled trial and were randomized into three groups (control, n = 27; HIIT with RT, n = 25; MCT with RT, n = 28). Exercise sessions were supervised with a frequency of 3 days per week. Inflammatory and lipid profiles were measured at baseline and at 1-year follow-up. Changes in inflammatory and lipid markers were assessed using generalized estimating equations. Results After adjusting for sex, age and baseline moderate-to-vigorous physical activity (MVPA), we observed a time-by-group interaction for Interleukin-6 (IL-6) in both the MCT with RT (β = − 0.70, p = 0.034) and HIIT with RT (β = − 0.62, p = 0.049) groups, whereas, only the HIIT with RT group improved total cholesterol (β = − 0.03, p = 0.045) and LDL-C (β = − 0.03, p = 0.034), when compared to control. No effect was observed for C-reactive protein (CRP), cortisol, tumour necrosis factor-α (TNF-α), soluble form of the haptoglobin-hemoglobin receptor CD163 (sCD163), triglycerides and HDL-C in both groups (p > 0.05). Conclusions Favorable adaptations on IL-6 were observed in both the HIIT and MCT combined with RT groups following a long-term 1-year exercise intervention in individuals with T2DM. However, only the HIIT with RT prevented further derangement of total cholesterol and LDL-C, when compared to the control group. Therefore, in order to encourage exercise participation and improve inflammatory profile, either exercise protocols may be prescribed, however, HIIT with RT may have further benefits on the lipid profile. Trial registration Clinicaltrials.gov ID: NCT03144505

scholarly journals A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness

10.2196/16629 ◽  
2020 ◽  
Vol 22 (5) ◽  
pp. e16629 ◽  
Author(s):  
Aikaterini Kassavou ◽  
Venus Mirzaei ◽  
James Brimicombe ◽  
Simon Edwards ◽  
Efthalia Massou ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Clinical Effectiveness ◽  
Control Group ◽  
Randomized Controlled

Background The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. Objective This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. Methods This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. Results A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t116=2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI −7.423 to 6.301), and hemoglobin A1c was 4.5 mmol/mol (95% CI −13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction. Conclusions Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.

scholarly journals Impact of Combined Training with Different Exercise Intensities on Inflammatory and Lipid Markers in Type 2 Diabetes: A Secondary Analysis from a 1-Year Randomized Controlled Trial

2020 ◽  
Author(s):  
João P. Magalhães ◽  
Diana A. Santos ◽  
Inês R. Correia ◽  
Megan Hetherington-Rauth ◽  
Rogério Ribeiro ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Lipid Profile ◽  
Total Cholesterol ◽  
Controlled Trial ◽  
Soluble Form ◽  
Randomized Controlled ◽  
Lipid Markers ◽  
Inflammatory Profile

Abstract Background: Exercise is a well-accepted strategy to improve lipid and inflammatory profile in individuals with type 2 diabetes (T2DM). However, the exercise intensity having the most benefits on lipids and inflammatory markers in patients with T2DM remains unclear. We aimed to analyse the impact of a 1-year combined high-intensity interval training (HIIT) with resistance training (RT), and a moderate continuous training (MCT) with RT on inflammatory and lipid profile in individuals with T2DM.Methods: Individuals with T2DM (n=80, aged 59 years) performed a 1-year randomized controlled trial and were randomized into three groups (control, n= 27; HIIT with RT, n=25; MCT with RT, n=28). Exercise sessions were supervised with a frequency of 3 days per week. Inflammatory and lipid profiles were measured at baseline and at 1-year follow-up. Changes in inflammatory and lipid markers were assessed using generalized estimating equations. Results: After adjusting for sex, age and baseline moderate-to-vigorous physical activity (MVPA), circulating levels of Interleukin-6 (IL-6) decreased for both the MCT with RT (β=-0.70, p=0.034) and HIIT with RT (β=-0.62, p=0.049) groups, whereas, only the HIIT with RT group improved total cholesterol (β=-0.03, p=0.045) and LDL-C (β=-0.03, p=0.034), when compared to control. No effect was observed for C-reactive protein (CRP), cortisol, tumour necrosis factor-α (TNF-α), soluble form of the haptoglobin-hemoglobin receptor CD163 (sCD163), triglycerides and HDL-C in both groups (p>0.05).Conclusions: Favorable adaptations on IL-6 were observed in both the HIIT and MCT combined with RT groups following a long-term 1-year exercise intervention in individuals with T2DM. However, the HIIT with RT group improved to a greater extent the values of total cholesterol and LDL-C, when compared to the MCT with RT group. Therefore, in order to encourage exercise participation and improve inflammatory profile, either exercise protocols may be prescribed, however, HIIT with RT may have further benefits on the lipid profile.Trial registration: clinicaltrials.gov ID:NCT03144505

scholarly journals Effectiveness of the Beyond Good Intentions Program on Improving Dietary Quality Among People With Type 2 Diabetes Mellitus: A Randomized Controlled Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Laura A. van der Velde ◽  
Jessica C. Kiefte-de Jong ◽  
Guy E. Rutten ◽  
Rimke C. Vos
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Dietary Quality ◽  
Self Management ◽  
Control Group ◽  
Randomized Controlled

Background and Aims: An appropriate diet is an essential component of the management of Type 2 Diabetes Mellitus (T2DM). However, for many people with T2DM, self-management is difficult. Therefore, the Beyond Good Intentions (BGI) education program was developed based on self-regulation and proactive coping theories to enhance people's capabilities for self-management. The aim of this study was to determine the effectiveness of the BGI program on improving dietary quality among a preselected group of people with T2DM after two-and-a-half years follow-up.Methods: In this randomized controlled trial, 108 people with T2DM were randomized (1:1) to the intervention (n = 56) (BGI-program) or control group (n = 52) (care as usual). Linear regression analyses were used to determine the effect of the BGI program on change in dietary quality between baseline and two-and-a-half years follow-up. In addition, potential effect modification by having a nutritional goal at baseline was evaluated. Multiple imputation (n = 15 imputations) was performed to account for potential bias due to missing data.Results: According to intention-to-treat analysis, participants in the intervention group showed greater improvements in dietary quality score than participants in the control group (β = 0.71; 95%CI: 0.09; 1.33) after follow-up. Having a nutritional goal at baseline had a moderating effect on the effectiveness of the BGI program on dietary quality (p-interaction = 0.01), and stratified results showed that the favorable effect of the intervention on dietary quality was stronger for participants without a nutritional goal at baseline (no nutritional goal: β = 1.46; 95%CI: 0.65; 2.27 vs. nutritional goal: β = −0.24; 95%CI: −1.17; 0.69).Conclusions: The BGI program was significantly effective in improving dietary quality among preselected people with T2DM compared to care as usual. This effect was stronger among participants without a nutritional goal at baseline. A possible explanation for this finding is that persons with a nutritional goal at baseline already started improving their dietary intake before the start of the BGI program. Future studies are needed to elucidate the moderating role of goalsetting on the effectiveness of the BGI program.

scholarly journals Impact of Combined Training with Different Exercise Intensities on Inflammatory and Lipid Markers in Type 2 Diabetes: A Secondary Analysis from a 1-year Randomized Controlled Trial

2020 ◽  
Author(s):  
João P. Magalhães ◽  
Diana A. Santos ◽  
Inês R. Correia ◽  
Megan Hetherington-Rauth ◽  
Rogério Ribeiro ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Lipid Profile ◽  
Total Cholesterol ◽  
Controlled Trial ◽  
Soluble Form ◽  
Randomized Controlled ◽  
Lipid Markers ◽  
Inflammatory Profile

Abstract Background: Exercise is a well-accepted strategy to improve lipid and inflammatory profile in individuals with type 2 diabetes (T2DM). However, the exercise intensity having the most benefits on lipids and inflammatory markers in patients with T2DM remains unclear. We aimed to analyse the impact of a 1-year combined high-intensity interval training (HIIT) with resistance training (RT), and a moderate continuous training (MCT) with RT on inflammatory and lipid profile in individuals with T2DM.Methods: Individuals with T2DM (n=80, aged 59 years) performed a 1-year randomized controlled trial and were randomized into three groups (control, n= 27; HIIT with RT, n=25; MCT with RT, n=28). Exercise sessions were supervised with a frequency of 3 days per week. Inflammatory and lipid profiles were measured at baseline and at 1-year follow-up. Changes in inflammatory and lipid markers were assessed using generalized estimating equations. Results: After adjusting for sex, age and baseline moderate-to-vigorous physical activity (MVPA), we observed a time-by-group interaction for Interleukin-6 (IL-6) in both the MCT with RT (β=-0.70, p=0.034) and HIIT with RT (β=-0.62, p=0.049) groups, whereas, only the HIIT with RT group improved total cholesterol (β=-0.03, p=0.045) and LDL-C (β=-0.03, p=0.034), when compared to control. No effect was observed for C-reactive protein (CRP), cortisol, tumour necrosis factor-α (TNF-α), soluble form of the haptoglobin-hemoglobin receptor CD163 (sCD163), triglycerides and HDL-C in both groups (p>0.05).Conclusions: Favorable adaptations on IL-6 were observed in both the HIIT and MCT combined with RT groups following a long-term 1-year exercise intervention in individuals with T2DM. However, only the HIIT with RT prevented further derangement of total cholesterol and LDL-C, when compared to the control group. Therefore, in order to encourage exercise participation and improve inflammatory profile, either exercise protocols may be prescribed, however, HIIT with RT may have further benefits on the lipid profile.Trial registration: clinicaltrials.gov ID:NCT03144505

scholarly journals Randomized Controlled Trial of Simple Salt Reduction Instructions by Physician for Patients with Type 2 Diabetes Consuming Excessive Salt

2021 ◽  
Vol 18 (13) ◽  
pp. 6913
Author(s):  
Chikako Oyabu ◽  
Emi Ushigome ◽  
Yuriko Ono ◽  
Ayaka Kobayashi ◽  
Yoshitaka Hashimoto ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Salt Intake ◽  
Controlled Trial ◽  
High Salt ◽  
Salt Reduction ◽  
Randomized Controlled ◽  
High Salt Intake ◽  
Significant Difference

Objectives: We verified the clinical usefulness of an approach method in which a physician gives simple salt reduction instructions during outpatient visits to patients with type 2 diabetes. Methods: This study was an open-blind, randomized controlled trial. Subjects were outpatients with type 2 diabetes whose estimated salt intake using spot morning urine sample exceeded the target of salt intake. The control group (CG) was notified only of the current salt intake, whereas the intervention group (IG) was given the brief salt reduction instruction by a physician in addition to the information regarding their current salt intake. Results: The change in estimated salt intake was −0.6 g (from 10.1 to 9.5 g, p = 0.029) in the CG after 8 weeks, and −0.9 g (from 10.1 to 9.2 g, p = 0.001) in the IG, although there were no significant differences between them (p = 0.47). After 24 weeks, both groups no longer differed significantly from the baseline. In addition, multivariate linear regression analyses indicated that high salt intake and low estimated glomerular filtration rate at baseline were significantly associated with salt reduction after 8 weeks. Conclusions: Salt-reducing effects were observed after 8 weeks in both the IG and CG, but no significant difference was observed. Moreover, patients with high salt intake and renal disfunction may be more effective in accepting salt reduction instructions. Making patients aware of the importance of salt reduction through a physician is effective for continuous salt reduction, and it is important to continue regular and repetitive guidance.

scholarly journals A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness (Preprint)

2019 ◽  
Author(s):  
Aikaterini Kassavou ◽  
Venus Mirzaei ◽  
James Brimicombe ◽  
Simon Edwards ◽  
Efthalia Massou ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Clinical Effectiveness ◽  
Control Group ◽  
Randomized Controlled

BACKGROUND The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. OBJECTIVE This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. METHODS This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. RESULTS A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (<i>t</i><sub>116</sub>=2.27; <i>P</i>=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI −7.423 to 6.301), and hemoglobin A<sub>1c</sub> was 4.5 mmol/mol (95% CI −13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; <i>P</i>=.04), but not in the control group (beta=.00, SE 1.35; <i>P</i>=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction. CONCLUSIONS Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.

scholarly journals Influence of education training in patients with type 2 diabetes in the improvement of lifestyle and biochemical characteristics: a randomized controlled trial

2019 ◽  
Vol 6 (4) ◽  
pp. 293-299
Author(s):  
Alida Ramaj ◽  
Fatjona Kamberi
Keyword(s):  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
The Mean ◽  
Education Training

Abstract Objective The objective of this randomized controlled trial study was to evaluate the education training in relation to lifestyle improvement in patients with type 2 diabetes through its influence in the levels of glycated hemoglobin (HbA1c), blood pressure, triglyceride, cholesterol levels, and body mass index (BMI). Methods The study included patients with type 2 diabetes randomly selected from 20 residential areas in Tirana, Albania where family physicians provide services. The sample size in total was 200 patients in both groups (control and intervention). The education training (four sessions) was conducted by trained nursing staff for 6 months. Patients were screened for the biochemical profile before and after the intervention. To compare the groups with respect to the interest outcomes, the t-test was used. The value of P < 0.05 was considered significant. Results There were 104 male patients and 96 female patients. The mean age was 54.9 ± 8.7. No significant differences were found between the study groups in relation to clinical and biochemical data before the education sessions. After the intervention, in the intervention group, the mean level of HbA1c was significantly lower than the value in the control group (6.2% vs 6.8%, P = 0.001) as well as for the mean values of BMI. The mean reduction (more than 15%) in HbA1c after the intervention was 43% in the intervention group and 2% in the control group (OR = 36.9, P < 0.05). Differences in BMI, HbA1c, triglycerides, and cholesterol were more significantly visible in the intervention group. However, the difference in systolic and diastolic blood pressure values was almost the same (P > 0.05). Conclusions The results of this study further support that the approach for education of patients with type 2 diabetes on changing lifestyle benefit the patient in controlling diabetes. It is believed that the establishment of diabetes education classes in health centers is an important investment in improving the management of type 2 diabetes.

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