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Metabolic and cardiovascular effects of very-low-calorie diet therapy in obese patients with type 2 diabetes in secondary failure: outcomes after 1year

VLCD therapy in obese patients with diabetes in secondary failure P. Dhindsa et al.
Metabolic and cardiovascular effects of very-low-calorie
diet therapy in obese patients with Type 2 diabetes in
secondary failure: outcomes after 1 year

School of Medical & Surgical Sciences, University of To evaluate the short-term and 1-year outcomes of an intensive very-low- Nottingham, and Jenny O’Neil Diabetes Centre, calorie diet (VLCD) on metabolic and cardiovascular variables in obese patients Southern Derbyshire Acute Hospitals, NHS Trust, with Type 2 diabetes (T2DM) and symptomatic hyperglycaemia despite combi- nation oral anti-diabetic therapy ± insulin, and to assess patient acceptability and the feasibility of administering VLCD treatment to this subgroup of patientsin a routine practice setting.
Forty obese patients with T2DM (22 M, mean age 52 years, body mass index (BMI) 40 kg /m2, duration of T2DM 6.1 years) and symptomatic hyper-glycaemia despite combination oral therapy (n = 26) or insulin + metformin(n = 14) received 8 weeks of VLCD therapy (750 kcal /day) followed by standarddiet and exercise advice at 2–3-month intervals up to 1 year. Insulin was dis-continued at the start of the VLCD, and anti-diabetic therapy was adjusted indi-vidually throughout the study, including (re)commencement of insulin as required.
Immediate improvements in symptoms and early weight loss reinforced good compliance and patient satisfaction. After 8 weeks of VLCD, body weightand BMI had fallen significantly: 119 ± 19–107 ± 18 kg and 40.6–36.6 kg/m2,respectively, with favourable reductions in serum total cholesterol (5.9– 4.9 mM),blood pressure (10/6 mmHg) and fructosamine (386 ± 73–346 ± 49 µM) (equatesto an HbA reduction of approximately 1%). Sustained improvements were evident after 1 year, with minimal weight regain, e.g. mean body weight 109 ± 18 kgand BMI 37 ± 4 kg/m2. Glycaemic control tended to deteriorate after 1 year.
The absence of a control group is a major limitation, but the results indicate that 8 weeks of VLCD treatment may be effective and well tolerated insymptomatic obese patients with T2DM in secondary failure, producing sus-tained cardiovascular and metabolic improvements after 1 year. VLCD therapyis a treatment option that deserves greater consideration in this difficult-to-treatpatient population.
VLCD, secondary failure, obesity, Type 2 diabetes, hyperglycaemic combination oral anti-diabetic therapy can be particularly Introduction
difficult. Few, if any, therapeutic strategies optimally achieve The clinical management of obese patients with Type 2 the desired outcomes of promoting weight loss and improving diabetes (T2DM) and symptomatic hyperglycaemia despite glycaemic control. Energy restriction and weight reductionhave independent, additive effects on metabolic and cardiovas-cular function [1]; for example, projections based on observa- Correspondence to: Professor Richard Donnelly MD, PhD, FRCP, FRACP, tional data suggest that a sustained 10-kg weight loss would University of Nottingham Division of Vascular Medicine, Derbyshire Royal Infirmary, Derby DE1 2QY, UK. E-mail: result in a 15% reduction in HbA , 10–20 mmHg fall in blood 2003 Diabetes UK. Diabetic Medicine, 20, 319 – 324
VLCD therapy in obese patients with diabetes in secondary failure • P. Dhindsa et al. pressure (BP) and a 20–25% reduction in total mortality 750 calories and 50 g of protein per day. Patients were also [2,3], but aggressive weight reduction programmes are not instructed to drink at least 1.5 l of calorie-free fluid per day.
routinely provided in many diabetes services, especially in theUK, often because of concerns about early weight regain Blood glucose monitoring and adjustment of anti-diabetic
and the lack of evidence of sustained medium to long-term treatment
Very-low-calorie diets (VLCDs) are defined as diets of All patients were regularly performing home blood glucose < 800 kcal /day [5]. They were developed to achieve maximum monitoring throughout the study, and those on insulin therapy weight loss while preserving lean body mass, and are usually at baseline had their insulin discontinued at the start of the VLCD.
Insulin was commenced or recommenced, as required, during given for 8–12 weeks as a liquid formula containing high levels subsequent follow-up, and similarly oral anti-diabetic treatments of protein enriched with vitamins, minerals, electrolytes and (metformin and sulphonylureas only) were adjusted to individual fatty acids. First-generation VLCDs were associated with patient needs in accordance with routine practice. Other medical sudden cardiovascular collapse [6], but the safety and toler- therapies were unchanged during the 8-week VLCD.
ability of newer formulations have been well established, albeitmainly in healthy non-diabetic subjects > 30% above idealbody weight [5,7]. Favourable effects of VLCD therapy on Statistical analysis
body weight and glycaemic control have also been reported in Clinical and biochemical parameters at baseline, following 8 patients with T2DM [8–10], but mostly in short-term studies weeks of VLCD and at 1 year, were compared by repeated meas- and following use of a VLCD as primary therapy in newly ures analysis of variance. All data are expressed as mean ± SD.
diagnosed patients [11,12]. In contrast, there is relatively littleinformation about metabolic and cardiovascular outcomes following VLCD treatment among symptomatic patients withT2DM in secondary failure and /or those recently commenced Forty-four patients agreed to participate in the study (approx.
on insulin with suboptimal glycaemic and symptom control.
half of all consecutive obese patients in secondary failure Thus, the purpose of this study was to evaluate short-term and attending our service during recruitment); four withdrew, all 1-year outcomes of an intensive 2-month VLCD as part of the within the first 5 days of starting the VLCD, mainly because of routine care of obese patients in secondary failure.
distaste and poor compliance, but there were no further drop-outs. Thus, 40 obese patients with a mean duration of T2DMof 6.1 years (22 male, mean age 52 years, range 33–69 years) Patients and methods
completed the study; one-half had evidence of micro- or macro- Consecutive obese patients with hyperglycaemic symptoms vascular complications. All patients were symptomatic of poor and poorly controlled T2DM despite maximum tolerated doses glycaemic control despite treatment with combined (sulphony- of oral anti-diabetic therapy (sulphonylurea and metformin) lurea and metformin) oral anti-diabetic therapy (n = 26) or ± insulin were invited to participate in a 12-month study divided insulin + metformin (n = 14). The average dose of insulin was into two phases: (i) 8 weeks of VLCD therapy with review by 102 ± 26 U/day among insulin-treated patients (n = 14). Base- the dietician after 2, 4 and 8 weeks (patients also had telephone line clinical parameters for the group were was follows: body access between visits); and (ii) a follow-up phase (week 8 to weight 115 ± 15 kg, body mass index (BMI) 40 ± 9.4 kg/m2, week 52) in which a standard low-calorie weight-maintenancediet was recommended together with simple advice about BP 152/82 ± 17/9 mmHg, serum triglycerides 3.4 ± 1.7 mM, exercise at bi-monthly visits to the Diabetes Centre. Clinical, total cholesterol 6.0 ± 1.2 mM, and fructosamine 387 ± 71 µM.
biochemical and haemodynamic parameters were recorded atbaseline, 8 weeks and 1 year. The effects of VLCD therapy on Tolerability
glycaemic control after 8 weeks and during subsequent follow-up were assessed by measurements of serum fructosamine Four patients were unable to tolerate the VLCD and withdrew (normal range 205–285 µm/l; a serum fructosamine of 400 µm/l in the first week of the study. There were no subsequent with- is approximately equivalent to an HbA of 10%). Patients gave drawals, and the VLCD was generally well tolerated with informed consent and a detailed protocol was approved by the favourable early effects on glycaemic symptoms and body weight reinforcing patient compliance. There were no signifi-cant electrolyte disturbances.
VLCD treatment
Patients were instructed to replace their entire diet with Slimfast, Short-term effects on body weight, metabolic and
a commercially available liquid meal replacement, for 8 weeks.
cardiovascular parameters
In addition to three Slimfast meal replacements per day, patientswere allowed one bowl of low-calorie vegetable soup, one bowl Following 8 weeks of VLCD therapy the average weight loss of vegetables or salad, two portions of fresh fruit and 300 ml was 12 kg, and mean BMI had fallen from 40 to 36 kg /m .
of skimmed milk for drinks. This provided approximately Hyperglycaemic symptoms were improved considerably 2003 Diabetes UK. Diabetic Medicine, 20, 319 – 324
Figure 1 Mean values at baseline (ᮀ), after 2 months very-low-calorie diet (hatched) and after 1 year (᭿) for (a) body weight, (b) body mass index,
(c) serum fructosamine, (d) total cholesterol, (e) systolic blood pressure (BP), and (f ) diastolic BP (n = 40).
following the VLCD and serum fructosamine was reduced for a typical patient who stopped and restarted insulin (at a from 386 to 341 µM (Fig. 1). There were additional improve- much lower dose) are illustrated in Fig. 3.
ments in serum lipids (e.g. 1.0 mmol / l reduction in totalcholesterol) and BP (average reduction 10/6 mmHg) (Fig. 1).
VLCDs have become widely established in the treatment of Outcomes at 1 year
uncomplicated obesity [5], but historical concerns about cardio- Average body weight and BMI after 1 year were 109.5 kg and vascular safety in patients with co-morbid conditions, and 37 kg/m2, respectively. Mean fructosamine for the group was somewhat pessimistic assumptions about early weight regain, 371 ± 41 µM, and 15 patients were on insulin (average dose have greatly limited the consideration of VLCDs as a treatment 41 U/day). Improvements in total cholesterol and BP were option in patients with diabetes, especially in the UK. Most previous studies have evaluated VLCDs as primary weight-losstherapy in small numbers of patients with newly diagnoseddiabetes [11,12], but this is the first report describing the short- Effects of VLCD on insulin requirements
term and 1-year outcomes of VLCD therapy in symptomatic Fourteen patients were treated with metformin + insulin prior patients with obesity and T2DM in secondary failure, includ- to starting the VLCD (average insulin dose 102 U/day). After ing a subgroup who had recently switched to insulin and 8 weeks, 10 patients had (re)commenced insulin (average dose metformin with a suboptimal effect on glycaemic and symptom 36 U/day), and after 1 year 15 patients were treated with insulin control. Compliance with three liquid meal replacements per (Fig. 2). The effects of the VLCD on home blood glucose levels day and only a small amount of solid foodstuff represents a 2003 Diabetes UK. Diabetic Medicine, 20, 319 – 324
VLCD therapy in obese patients with diabetes in secondary failure • P. Dhindsa et al. Figure 2 Proportion of patients treated with insulin (and average daily dose) at baseline, after 2 months’ very-low-calorie diet (VLCD) and after 1 year.
Figure 3 Home blood glucose recordings for an individual patient who was taking 70 U/day of insulin prior to commencing the very-low-calorie diet
(VLCD). Insulin was discontinued on starting the VLCD and recommenced 9 weeks later. However, during follow-up, blood glucose levels were
considerably better on less than half the pre-VLCD dose of insulin (20–30 U/day), illustrating sustained improvements in insulin sensitivity and dose
requirements following the VLCD.
major challenge, but these patients were highly motivated by and there is evidence that VLCDs have a modest satiating their symptoms, lack of success with previous therapeutic and effect due to the high protein content and the ketosis induced dietary interventions, and a realization that energy restriction in the short term and major weight loss in the medium term The VLCD was generally well tolerated and highly effective were unavoidable objectives for improved well-being and in reducing body weight (on average by 12 kg) and BMI, with glycaemic control. Patients reported an almost immediate favourable reductions in BP (10/6 mmHg) and levels of serum improvement in diabetic symptoms which, combined with early cholesterol (17%) and fructosamine (40 µM, equivalent to weight loss even in the first week, probably encouraged good 0.8–1% HbA ) after 2 months. The short-term metabolic and compliance with the VLCD and explains why there were no haemodynamic changes are entirely consistent with improved drop-outs beyond the first few days. Feelings of hunger during peripheral and hepatic insulin sensitivity [14], although energy VLCD treatment are generally less than might be expected, restriction, independent of weight loss, has an important effect 2003 Diabetes UK. Diabetic Medicine, 20, 319 – 324
on glycaemic control, especially in the early phase of VLCD modest difference in body weight (3.5 kg favouring the VLCD treatment [15]. There were no gender-related differences in group) did not justify further use of pulsed VLCDs, but alter- weight loss in the present study, even though some evidence native VLCD regimes, e.g. frequent short periods of 1–5 days, has suggested that male (non-diabetic) subjects lose more weight than women [7]. The secondary benefits on other There has been a long history of debate over the safety and cardiovascular risk factors, especially BP, should not be under- utility of VLCDs in routine clinical practice [6,7], but modern estimated. For example, a reduction of 10/6 mmHg is equiva- formulations are effective, well tolerated and associated with lent to the difference in average BP (10/5 mmHg) between the high levels of patient satisfaction. Importantly, in the present ‘tight’ and ‘less-tight’ BP control groups of the UK Prospective study VLCD therapy was administered and supervised by a Diabetes Study, an effect which, maintained over 10 years, specialist dietician working within the framework of a routine produced a 32% reduction in diabetes-related deaths [16].
diabetes service using an agreed protocol. Dieticians have In the post-VLCD follow-up period, patients received stand- often been reluctant to use VLCDs without close medical ard levels of diabetes care, including diet and exercise advice supervision, but this study has demonstrated the feasibility of from a specialist dietician at 2–3-month intervals. Even a dietician-led programme of VLCD education and treatment without intensive behavioural or dietary counselling, sustained for those obese patients with T2DM in secondary failure in improvements in various parameters were still apparent after whom the physician has made a referral. There should be 1 year. In particular, although there had been some weight greater consideration given to VLCDs as a treatment option in regain and a deterioration in glycaemic control, levels of body this difficult-to-manage and symptomatic patient group.
weight, BMI and fructosamine were still significantly lowerthan baseline pre-VLCD values. This also applied to those References
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