Abstract
Objectives:
To investigate the effects of long-term treatment with a new enteral formula low in carbohydrates and high in monounsaturated fatty acids (MUFAs), in comparison with a standard formula, on glycaemic control in tube-fed type II diabetic patients.
Design:
Randomised, double-blind, controlled, multi-centre trial.
Setting:
Early rehabilitation centres, primary care and nursing facilities.
Subjects:
A total of 78 patients with insulin-treated type II diabetes with HbA1C ≥7.0% and/or fasting blood glucose >6.66 mmol/l, who required enteral tube feeding due to neurological dysphagia.
Interventions:
Patients received 113 kJ (27 kcal)/kg of body weight of either test feed or an isoenergetic, isonitrogenous enteral formula (control) for 12 weeks. Glycaemic control (total daily insulin dosage (IU), fasting blood glucose, and HbA1C) and gastrointestinal tolerance were monitored daily.
Results:
After 12 weeks, median values for changes from baseline were as follows (test group vs control group, ‘data as available’ analysis): total daily IUs −6.0 vs 0.0 (P=0.0024), fasting blood glucose (mmol/l) −1.59 vs −0.08 (P=0.0068); HbA1C (%) −0.8 vs 0.0 (P=0.0016). Both formulas were tolerated comparably.
Conclusions:
This study indicates that in tube-fed insulin-treated type II diabetic patients, the new low-carbohydrate, high MUFA formula results in a more effective glycaemic control than the standard diet, while being comparable in safety.
Sponsorship:
The study was sponsored by Fresenius Kabi Deutschland GmbH, Bad Homburg, Germany.
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References
Alvarsson M, Sundkvist G, Lager I, Henricsson M, Berntorp K, Fernqvist-Forbes E, Steen L, Westermark G, Westermark P, Orn T & Grill V (2003): Beneficial effects of insulin versus sulphonylurea on insulin secretion and metabolic control in recently diagnosed type 2 diabetic patients. Diabetes Care 26, 2231–2237.
American Diabetes Association (ADA) (2000): Nutrition recommendations and principles for people with diabetes mellitus. Diabetes Care 23 (Suppl 1), S1–S116.
American Diabetes Association (ADA) (2001): Postprandial blood glucose. Diabetes Care 24, 775–778.
American Diabetes Association (ADA) (2002): Evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications. Diabetes Care 25, 202–212.
Anderson RA (2000): Chromium in the prevention and control of diabetes. Diabetes Metab. 26, 22–27.
Bauer P & Köhne K (1994): Evaluation of experiments with adaptive interim analyses. Biometrics 50, 1029–1041.
Böttcher H, Mayr P, Pause M & Fürst P (2000): A novel disease-specific tube feeding formula is beneficial in treatment of critically ill NIDDM patients. Clin. Nutr. 19 (Suppl 1), S230 (abstract).
Celaya S, Sanz A, Homs C, Luque P, de la Orden P, Civeira E & Elosegui LM (1992): Experience with an enteral diet with fiber and a high fat content in ICU patients with glucose intolerance. Nutr. Hosp. 7, 260–269.
Colditz GA, Miller JN & Mosteller F (1988): Measuring gain in the evaluation of medical technology. The probability of a better outcome. Int. J. Technol. Assess. Health Care 4, 637–642.
Commission of the European Communities (1992): Reports of the Scientific Committee for Food (thirty-first series): Nutrient and energy intakes for the European Community. GT-29-98-003-EN-C Internet:http://europa.eu.int/comm/food/fs/sc/scf/reports/scf_reports_43.pdf(accessed 11 December 1992).
Connor H, Annan F, Bunn E, Frost G, McGough N, Sarwar T & Thomas B (2003): The implementation of nutritional advice for people with diabetes. Diabet. Med. 20, 786–787.
Coulston AM (1998): Clinical experience with modified enteral formulas for patients with diabetes. Clin. Nutr. 17 (Suppl 2), S46–S56.
Coulston AM (2000): Enteral nutrition in the patient with diabetes mellitus. Curr. Opin. Clin. Nutr. Metab. Care 3, 11–15.
Craig LD, Nicholson S, SilVerstone FA & Kennedy RD (1998): Use of a reduced-carbohydrate, modified-fat enteral formula for improving metabolic control and clinical outcomes in long-term care residents with type 2 diabetes: results of a pilot trial. Nutrition 14, 529–534.
del Carmen Crespillo M, Olveira G, de Adana MS, Rojo-Martinez G, Garcia-Aleman J, Olvera P, Soriguer F & Munoz A (2003): Metabolic effects of an enteral nutrition formula for diabetes: comparison with standard formulas in patients with type 1 diabetes. Clin. Nutr. 22, 483–487.
Eckel RH (2004): Diabetes and dietary macronutrients: is carbohydrate all that bad? Am. J. Clin. Nutr. 80, 537–538.
European Agency for the Evaluation of Medicinal Products (EMEA) (1998): ICH Topic E9, Statistical Principles for Clinical Trials. Step 4, Consensus guideline. CPMP/ICH/363/96. Internet:http://emea.eu.int/pdfs/human/ich/036396en.pdf(accessed 5 February 1998).
European Association for the Study of Diabetes (EASD) (2000): Recommendations for the nutritional management of patients with diabetes mellitus. Eur. J. Clin. Nutr. 54, 353–355.
Franz MJ, Bantle JP, Beebe CA, Brunzell JD, Chiasson JL, Garg A, Holzmeister LA, Hoogwerf B, Mayer-Davis E, Mooradian AD, Purnell JQ & Wheeler M, American Diabetes Association (2004): Nutrition principles and recommendations in diabetes. Diabetes Care 27 (Suppl 1), S36–S46.
Fürst P (1998): Consensus roundtable on nutrition support of tube-fed patients with diabetes. Clin. Nutr. 17 (Suppl 2), S3–S6.
Garg A (1998): High-monounsaturated-fat diets for patients with diabetes mellitus: a meta-analysis. Am. J. Clin. Nutr. 67 (Suppl 3), S577–S582.
Gerhard GT, Ahmann A, Meeuws K, McMurry MP, Duell PB & Connor WE (2004): Effects of a low-fat diet compared with those of a high-monounsaturated fat diet on body weight, plasma lipids and lipoproteins, and glycemic control in type 2 diabetes. Am. J. Clin. Nutr. 80, 668–673.
Golay A, Schneider H, Bloise D, Vadas L & Assal J (1995): The effect of a liquid supplement containing guar gum and fructose on glucose tolerance in non-insulin-dependent diabetic patients. Nutr. Metab. Cardiovasc. Dis. 5, 141–148.
Gumbiner B, Low CC & Reaven PD (1998): Effects of a monounsaturated fatty acid-enriched hypocaloric diet on cardiovascular risk factors in obese patients with type 2 diabetes. Diabetes Care 21, 9–15.
Ha TK & Lean ME (1998): Recommendations for the nutritional management of patients with diabetes mellitus. Eur. J. Clin. Nutr. 52, 467–481.
Haslbeck M, Stiller R & Niederreiter B (1995): Günstige metabolische Wirkungen einer kohlenhydratmodifizierten, bilanzierten Diät bei Typ-II-Diabetes. Aktuel. Ernaehr. Med. 20, 215–220.
Hofman Z, van Drunen JD, de Later C & Kuipers H (2004): The effect of different nutritional feeds on the postprandial glucose response in healthy volunteers and patients with type II diabetes. Eur. J. Clin. Nutr. 58, 1553–1556.
Lachin JM (1992): Some large-sample distribution-free estimators and tests for multivariate partially incomplete data from two populations. Stat. Med. 11, 1151–1170.
Low CC, Grossman EB & Gumbiner B (1996): Potentiation of effects of weight loss by monounsaturated fatty acids in obese NIDDM patients. Diabetes 45, 569–575.
Masur H (2000): Skalen und Scores in der Neurologie. Stuttgart, New York: Thieme Verlag.
McCargar LJ, Innis SM, Bowron E, Leichter J, Dawson K, Toth E & Wall K (1998): Effect of enteral nutritional products differing in carbohydrate and fat on indices of carbohydrate and lipid metabolism in patients with NIDDM. Mol. Cell. Biochem. 188, 81–89.
Mesejo A, Acosta JA, Ortega C, Vila J, Fernandez M, Ferreres J, Sanchis JC & Lopez F (2003): Comparison of a high-protein disease-specific enteral formula with a high-protein enteral formula in hyperglycemic critically ill patients. Clin. Nutr. 22, 295–305.
Moher D, Schulz KF & Altman DG (2001): The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 357, 1191–1194.
Morley JE & Perry III HM (1991): The management of diabetes mellitus in older individuals. Drugs 41, 548–565.
Parhofer K, Göke B, Hauner H, Laube H, Lehnert H, Schrezenmeir J & Toeller MD (2003): DGEM-Leitlinie Enterale Ernährung: Diabetologie. Aktuel. Ernaehr. Med. 28 (Suppl 1), S103–S109.
Printz H, Recke B, Fehmann HC & Goke B (1997): No apparent benefit of liquid formula diet in NIDDM. Exp. Clin. Endocrinol. Diabetes 105, 134–139.
Roth EJ, Lovell L, Harvey RL, Bode RK & Heinemann AW (2002): Stroke rehabilitation: indwelling urinary catheters, enteral feeding tubes, and tracheostomies are associated with resource use and functional outcomes. Stroke 33, 1845–1850.
Sanz-Paris A, Calvo L, Guallard A, Salazar I & Albero R (1998): High-fat versus high-carbohydrate enteral formulae: effect on blood glucose, C-peptide, and ketones in patients with type 2 diabetes treated with insulin or sulfonylurea. Nutrition 14, 840–845.
Schafer RG, Bohannon B, Franz MJ, Freeman J, Holmes A, McLaughlin S, Haas LB, Kruger DF, Lorenz RA & McMahon MM, American Diabetes Association (2004): Diabetes nutrition recommendations for health care institutions. Diabetes Care 27 (Suppl 1), S55–S57.
Stürmer W, Kramer E, Kasper H & Schrezenmeir J (1994): Favourable glycaemic effects of a new balanced liquid diet for enteral nutrition—results of a short-term study in 30 type II diabetic patients. Clin. Nutr. 13, 221–227.
van Drunen J, Hofman Z & Kuipers H (2003): The glycemic index (GI) of standard and diabetes-specific clinical nutrition products. Clin. Nutr. 22 (Suppl 1), S13–S14. (abstract).
Wei LJ & Lachin JM (1984): Two-sample asymptotically distribution-free tests for incomplete multivariate observations. J. Am. Stat. Ass. 79, 653–661.
Wright J (2000): Total parenteral nutrition and enteral nutrition in diabetes. Curr. Opin. Clin. Nutr. Metab. Care 3, 5–10.
Acknowledgements
We thank Derek Barton for his assistance in preparing the manuscript. The study was sponsored by Fresenius Kabi Deutschland GmbH, Bad Homburg, Germany.
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Guarantor: M Pohl and P Mayr.
Contributors: All investigators contributed to the study conception and design. MP, PM, MM-R, FL, ML, JE, and MH co-ordinated fieldwork and supervised intervention implementation and field data collection. VWR obtained and analysed the data. MP wrote the first draft of the article. All authors critically revised the first draft for content and contributed to the final draft.
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Pohl, M., Mayr, P., Mertl-Roetzer, M. et al. Glycaemic control in type II diabetic tube-fed patients with a new enteral formula low in carbohydrates and high in monounsaturated fatty acids: a randomised controlled trial. Eur J Clin Nutr 59, 1221–1232 (2005). https://doi.org/10.1038/sj.ejcn.1602232
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DOI: https://doi.org/10.1038/sj.ejcn.1602232
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