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14th September 2021
Type 2 diabetes is characterised by a progressive loss of beta-cell function in the pancreas and recent data have shown that intermittent very-low calorie diets (IVLCD) can result in a marked metabolic improvement in as little as seven days. However, maintenance of a IVLCD can be difficult over time and one study found that after 12 months of intensive weight management, less than half (46%) of patients were in diabetic remission. Among obese patients, the use of intermittent very-low calorie diets (500 – 600 kcal/d) for three days each week, was found to be an effective weight loss strategy. Moreover, a similar strategy, using a IVLCD for two days per week has been successfully used in patients with type 2 diabetes.
Nevertheless, the optimal IVLCD for those with type 2 diabetes remains to be determined and this led a team from the Division of Endocrinology and Metabolism, Chulalongkorn University, Thailand, to compare different protocols of IVLCD among those with type 2 diabetes. The team undertook a randomised controlled trial that compared the impact of a two-day/week and a four-day/week IVLCD versus a control group, on glycaemic control and diabetes remission in a group of obese type 2 patients. Included patients were between 30 and 60 years of age and with type 2 diabetes diagnosed within the last 10 years. Enrolled patients had a body mass index (BMI) > 23 and a HbA1c level between 6.5 and 10%. Individuals were then randomised to either the two, or four-days/week IVLCD arm or a control group (in which they received a normal diet of 1500 – 2000 kcal/day). The IVLCD groups had an intake of 600 kcal/day on either two or four days each week. Patients were assessed every two weeks for the duration of the study (20 weeks). The primary outcome of interest was a change in glycaemic control (glucose and HbA1c) and rate of diabetes remission, defined as a HbA1c of < 6.5% in the absence of pharmacological therapy at the end of the study.
A total of 40 participants with a mean age range of 49.6 years (73% female) and a mean BMI of 30.1 were included in the final analysis. The mean duration of diabetes was 4.9 years and the baseline HbA1c was 7.4% with 90.6% of participants prescribed metformin. There were significant reductions compared to baseline in HbA1c levels in both IVLCD groups with 64% of those in the 4-day/week and 29% in the 2-day/week achieving levels < 6.5%. Furthermore, diabetes remission was achieved in 29% of patients in both the 2-day and 4-day groups. In addition, complete withdrawal of all diabetic medication occurred in 64% of the 2 day/week group and 86% of those in the 4 day/week group. The mean reduction in BMI in the 4 day/week group was 3.6 and 2.1 kg in the 2 day/week group although this difference between the two groups was not-significant.
The authors concluded that given the similar level of diabetes remission in both groups, either would be beneficial to obese type 2 diabetic patients.
UmPhonsathien M et al. Effects of intermittent very-low calorie diet on glycemic control and cardiovascular risk factors in obese patients with type 2 diabetes mellitus: A randomised controlled trial. J Diabetes Investig 2021
14th June 2021
The monitoring of blood glucose is paramount to the safe and effective management of all diabetic patients. Typically, insulin regimes can be basal only (i.e., long-acting agents used once or twice daily) or a combination of basal and prandial, i.e., rapid-acting agents used to control the mead-induced glucose spikes. Moreover, assessment of blood glucose levels is achieved through the use of either testing strips or real-time continuous glucose monitoring (CGM). However, in practice self-testing has been shown to be under-utilised and while the latter has been shown to improve diabetic control in type 2 diabetes using a combined insulin regime, little is known about the effectiveness of CGM in patients with less intensive insulin regimes. Therefore, a team of researchers from the International Diabetes Centre, Minneapolis, US, performed a randomised controlled trial to determine the effectiveness of CGM in primary care adults with type 2 diabetes using only basal insulin compared with the use of traditional blood glucose monitoring (BGM). Included patients had a baseline HbA1c level of 7.8% to 11.5%, self-reported BGM monitoring of at least 3 or more times per week and possession of a smartphone compatible with the CGM device for uploading data. The primary outcome measure was the HbA1c level after 8 months and key secondary outcomes were CGM-measured time in the target glucose range (70–180mg/dl) and the time with glucose levels above 250mg/dl.
A total of 175 participants with a mean age of 57 years (50% women) and with a mean HbA1c level of 9.1% were randomised in a 2:1 fashion to CGM or BGM. After 8 months, the mean HbA1c reduced to 8.0% in the CGM group and to 8.4% in the BGM group (p = 0.02). In the GCM group, the mean percentage of time in the target glucose range was 59% compared to 43% in the BGM group (p < 0.001). Similarly, there was a significantly lower time where glucose levels exceeded 250mg/dl (11% vs 27%, CGM vs BMG, p < 0.01).
In discussing their findings, the authors noted that the greater improvements seen in HbA1c in the CGM group were due to an increased period of time for which glucose levels remained with the target range. Nevertheless, a limitation recognised by the authors was the use of diabetic specialists, which is not standard practice in primary care and that this may have limited the generalisability of their findings. Despite this, they concluded that the use of CGM resulted in superior diabetic control compared with self-monitoring.
8th June 2021
Weight loss in patients with type 2 diabetes improves metabolic outcomes such as insulin resistance and glycaemic control. This is particularly important in Asian populations where data indicate an increased prevalence of obesity. While traditionally lifestyle interventions have been delivered in face-to-face sessions, potential barriers such as the need for formal appointments, travel and associated costs, together with potential time constraints, can limit the value of these sessions.
In recent years, the development of smartphone technology has enabled the delivery of lifestyle interventions for patients with long-term conditions and which circumvent some of the problems encountered with face-to-face meetings. However, the effectiveness of smartphone-based apps can depend, to some extent, on the cultural appropriateness of the material provided. In an attempt to examine the value of a culturally and contextualised smartphone app, designed to deliver lifestyle interventions, a team from the Department of Dietetics, National University Hospital, Singapore, undertook a randomised, controlled trial to compare a smartphone-based intervention with usual care. Included participants were adults with type 2 diabetes with a body mass index (BMI) of 23 or greater and at the start of the study, all participants received a single advisory session from a dietician concerning weight and physical activity. Intervention participants were then required to use the app for at least 6 months (to track weight and activity levels) and to communicate (via the app) regularly with a dietician. The primary outcome was the change in body weight after six months, whereas secondary outcomes were changes in metabolic profiles (e.g., HbA1c, fasting blood glucose, blood pressure).
In total, 204 participants were enrolled and randomised to the intervention (99) or control. The mean age of intervention participants was 51.6 years (33.3% female) with an average weight of 84 kg and BMI of 30.3. After six months, participants in the intervention group had a significantly greater mean weight loss (3.6 kg vs 1.2kg, intervention vs control, p < 0.01). In addition, there was a greater change in mean HbA1c levels (-0.7% vs 0.03%, intervention vs control) and in the proportion of participants seeing a reduction in their use of diabetic medications (23.3% vs 5.4%, intervention vs control). There were also favourable changes in fasting glucose levels and diastolic blood pressure. Finally, nearly two-thirds (62%) of intervention participants used the smartphone app at least 75% of the days during the 6-month period.
Commenting on their findings, the authors noted how the intervention group’s weight loss was comparable to the results achieved from face-to-face sessions and, more importantly, this loss was sustained over a six-month period. The authors concluded that the smartphone app led to significant weight loss and metabolic parameters and that future work should focus on the lifestyle factors more likely to achieve successful outcomes.
Lim SL et al. Effect of a Smartphone App on Weight Change and Metabolic Outcomes in Asian Adults with Type 2 Diabetes. A Randomised Clinical Trial. JAMA Netw Open 2021
18th January 2021
The monoclonal antibody bimagrumab binds to and blocks the activity of the activin type II receptor (ActRII), promoting skeletal muscle hypertrophy and reducing body fat mass. Given this potential action, researchers from Pennington Biomedical Research Centre, Louisiana State University, in the US, hypothesised that the drug might represent a beneficial approach to the management of obese, type 2 diabetic patients. They recruited type 2 diabetes aged between 18 and 75 years with a glycated haemoglobin (HbA1C) of 6.5 to 10%, a body mass index (BMI) of 28 to 40 and a weight of between 65 and 140kg. All patients were prescribed either metformin (as mono-therapy), dipeptidyl peptidase 4 (DPP4) inhibitors, (again as mono-therapy) or a combination of both drugs, although a small number were not prescribed any diabetic medicines. These treatments were permitted because of their weight neutral effect. Eligible participants were randomised 1:1 to either Bimagrumab (10mg/kg to a maximum of 1200mg in 5% dextrose) or placebo (5% dextrose) via 30-minute intravenous infusion every 4 weeks for a total of 48 weeks and both clinicians and patients were blinded to allocation. The primary endpoint was a change from baseline to week 48 in total fat mass (FM) which was measured by dual energy X-ray absorptiometry. Secondary endpoints included change in diabetic status (HbA1C), body weight, BMI and both HOMA2 and the Matsuda index which are measures of insulin sensitivity.
A total of 75 patients were randomised to either bimagrumab (37) or placebo (38). The mean age of those assigned to bimagrumab was 60.7 years (62.2% female). At week 48, total FM decreased by a mean of 7.49 kg in the bimagrumab group vs 0.18 kg in the placebo group (p < 0.01). Similarly, there were significant reductions in BMI (2.19 vs 0.28, p < 0.001), body weight (5.90 kg vs 0.79 (p < 0.01) and HbA1C levels (0.76 vs 0.04, p < 0.05). Interestingly, the bimagrumab group also saw a significant increase in lean muscle mass compared to the placebo group (1.70 kg vs 0.4 kg, p < 0.001). However, there were no significant changes to either measure of insulin sensitivity or in use of anti-diabetic medication. Commenting on their findings, the authors noted that treatment with bimagrumab led to a small increase in lean muscle mass which is a beneficial effect given that muscle loss is typically observed when type 2 diabetes adopt a low-calorie diet.
They concluded that inhibition of ActRII may provide a novel pathway for the management of excess body fat and metabolic disturbances as seen in type 2 diabetics.
Heymsfield SB et al. Effect of Bimagrumab vs placebo on body fat mass among adults with type 2 diabetes and obesity. A phase 2 randomised clinical trial. JAMA Netw Open 2021
23rd October 2020
Patients with type 2 diabetes have also been shown to have an increased the risk of cognitive impairment and dementia. Achievement of good glycaemic control is associated with a reduction in the risk of many of adverse health outcomes and this can be attained through weight loss, but the evidence for an improvement in cognitive impairment is currently mixed. In this study, researchers from several centres in the US have reported on the results from the Action for Health in Diabetes (look AHEAD) study which suggests that it is glycaemic control, rather than weight reduction, which has the greatest impact on cognitive functioning. The look AHEAD study is a single blind, randomised trial that recruited 5145 individuals during 2001 to 2004 with a BMI >25kg/m2, a HbA1c < 11%, triglycerides < 600mg/dl and a systolic/diastolic blood pressure < 160/100 mmHg. Participants were randomised to either an intensive lifestyle intervention (ILI) or a diabetes support and education (DSE) control group and the interventions continued until 2012, which was an average of 9.9 years. For the cognitive assessment arm, 1089 participants from the original study were recruited at year 8 or 9 of follow-up and undertook 2 or 3 cognitive assessments, that evaluated verbal learning, memory, speed of processing, executive function and global cognitive functioning.
There was an equal number of participants from the ILI and DSE groups; the mean age of both samples was 58 years, and 42% of both groups was male and roughly 10% had pre-existing cardiovascular disease. Improvements in blood sugar control was associated with greater improvements in cognitive scores for most measures. In contrast, the association between improvements in weight loss and cognitive scores was less clear and depended to some extent, on the cognitive measure.
The authors were unable to account for these findings and concluded that any improvements in cognitive function were largely dependent on baseline levels of adiposity and cardiovascular disease history.
Carmichael OT et al. Long-term change in physiological markers and cognitive performance in type 2 diabetes: the look AHEAD trial. J Clin Endrocrinol Metab 2020; doi:10.1210/clinem/dgaa591