Original ArticleTube feeding with a diabetes-specific feed for 12 weeks improves glycaemic control in type 2 diabetes patients☆,☆☆
Introduction
A major goal of diabetes management is to achieve glycaemic control.1 A growing body of evidence suggests that in addition to fasting glucose concentrations postprandial glucose concentrations should also be targeted to improve glycaemic control.2, 3 Due to its effect on (postprandial) blood glucose excursions and lipid levels, nutrition plays an important role in achieving metabolic control in diabetes patients.4, 5 The short-term consequences of hyperglycaemia include: polyuria, increased thirst, dehydration, weight loss and fatigue. Furthermore, hyperglycaemia is associated with a increased infection risk6 and impaired wound healing.7 Long term complications are the microvascular and macrovascular complications.8, 9, 10
Some diabetic patients with functioning gastrointestinal tract who cannot maintain sufficient oral intake need tube feeding as the treatment of choice. Diabetes-specific formulas are developed to control blood glucose concentrations. A recent systematic review showed that use of diabetes-specific formulas is associated with improved glycaemic control compared with standard formulas11 and should therefore be considered in hyperglycaemic hospitalized diabetes patients.
Only a few studies have investigated the effect of longer-term feeding with a diabetes-specific tube feed on glycaemic control of diabetes patients.12, 13, 14 The trial duration in these studies ranged from 13 days (median)13 to 12 weeks.12, 14 None of these studies investigated the effect of bolus supplementation on postprandial glucose levels after longer-term feeding with a diabetes-specific formula. It had been shown that a soy-protein based, high MUFA, multi-fibre diabetes-specific tube feed lowered the postprandial glucose response compared to a standard formula after a single bolus15 and during continuous feeding lasting 6 h.16 In the present study effects of 12 weeks supplementation of this diabetes-specific tube feed on glycaemic control (including postprandial glucose responses and HbA1c) and lipid parameters were assessed. Study duration was 12 weeks to be able to also study effects on HbA1c.
Section snippets
Subjects
Patients diagnosed with type 2 diabetes according to the WHO criteria were included. Inclusion criteria were: disease duration for more than 6 months, age > 18 years, 6.0% < HbA1c < 9.5%, in need of nutritional support by tube feeding for at least 12 weeks by either percutaneous endoscopic gastrostomy or nasogastric tube and a functioning gastrointestinal tract. Exclusion criteria were: concomitant therapy with systemic glucocorticoids or acarbose, acute severe heart failure (NYHA class 4), end stage
Results
In total, 181 patients were prescreened by the 5 centers, from September 2005 until May 2007. Main reasons that patients were not eligible for the study were: refusal (of the legal representative) to participate, (or for participation), HbA1c levels <6.0% or death during the screening period before randomization. Eventually, 25 subjects were randomized into the study, twelve in the diabetes-specific tube feed group and 13 in the standard tube feed group (Fig. 1). Twenty-one patients resided in
Discussion
Current study results indicate that a soy-protein based, high MUFA, multi-fibre diabetes-specific tube feed can also lower postprandial glucose levels after 12 weeks use and further improves overall glycaemic control (HbA1c) in diabetes patients on regular anti-diabetic medical treatment.
Previous studies using a single administration of this diabetes-specific tube feed as continuous feeding during 6 h16 or as single bolus15 resulted in lower postprandial glucose responses compared to a standard
Conflict of interest
N. Vaisman: Consultant to Danone Research.
M. Lansink, C. Rouws, K. van Laere; employee of Danone Research, Centre for Specialised Nutrition.
R. Segal: No conflict of interest.
E. Niv: No conflict of interest.
T. Bowling: No conflict of interest.
D. Waitzberg: Danone Research paid for flights and accommodation to attend research meetings to discuss the study. No other conflict of interest.
J. Morley: Grant/Research support: Ascend, Baxter and Numico.
Speaker's Bureau: Merck &Co., Novartis, Indevus,
Acknowledgements
The study was sponsored by Danone Research, Centre for Specialised Nutrition. Study sponsor was involved in study design, analysis and interpretation of the data, writing the manuscript and in the decision to submit the manuscript for publication.
The authors would like to thank: Elleny Balder for performing the statistical analyses, Arja Kreeft and Tessa van Rossenberg for study monitoring, Yahalomit Zaruk for coordinating the trial in Tel Aviv, Helen Gibbs for being the lead patient
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Cited by (40)
Diabetes-specific formulas high in monounsaturated fatty acids and metabolic outcomes in patients with diabetes or hyperglycaemia. A systematic review and meta-analysis
2020, Clinical NutritionCitation Excerpt :They showed statistically significant but low effect size of SMD −0.34 (95% CI −0.65 to −0.03) and inter-study homogeneity (p = 0.42). Mean blood HDL data were obtained from six studies [25,26,29–31,34] reporting a SMD of 0.42 (95% CI 0.08 to 0.7), which resulted in a significantly higher moderate level of HDL associated with DSF use with inter-study homogeneity (p = 0.075). In relation to safety and tolerance, gastrointestinal adverse events reported by the authors of the included studies were analysed [20,23,28–30,32,33,35,36], without showing significant differences between treatments.
Evidence-based recommendations and expert consensus on enteral nutrition in the adult patient with diabetes mellitus or hyperglycemia
2017, NutritionCitation Excerpt :Additionally, these formulas may reduce glycemic variability and hypoglycemia versus standard formulas, at least in the short term [70,73,74]. However, objective data on a reduction of morbidity and mortality in these patients are lacking [69–73,75]. In malnourished ambulatory patients treated with oral supplementation (in addition to usual diet) for a medium term (3 mo), the use of a diabetes-specific supplement rather than standard oral nutritional supplements, also may reduce postprandial glucose levels and improve nutritional status [76].
Inpatient Diabetes Management in the Twenty-First Century
2016, Endocrinology and Metabolism Clinics of North AmericaCitation Excerpt :The recommended glycemic goal is less than 180 mg/dL (see Table 1); however, observational studies suggest that a lower BG target of less than 150 mg/dL improves clinical outcomes for those receiving nutritional support without increasing hypoglycemia risk.34 Multiple RCTs support the use of lower-carbohydrate-content (diabetes specific) enteral formulas because of their association with reduced hyperglycemia.35–39 In standard enteral formulas, 55% to 60% of the calories are provided by carbohydrates, whereas diabetic-specific formulas reduce carbohydrate contribution by a maximum of 40% of the total caloric content.
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This work has been presented at the ESPEN conference, 12-16 september 2008, Florence, Italy.
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ISRCTN57864852.