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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

European Journal of Clinical Nutrition volume 59, pages 1221–1232 (2005)Cite this article

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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Acknowledgements

We thank Derek Barton for his assistance in preparing the manuscript. The study was sponsored by Fresenius Kabi Deutschland GmbH, Bad Homburg, Germany.

Author information

Authors and Affiliations

  1. Department of Early Neurological Rehabilitation, Klinik Bavaria, Kreischa, Germany

    M Pohl

  2. Doctor's practice with emphasis on diabetes, Stockach, Germany

    P Mayr

  3. Neurological Clinic, Bad Aibling, Germany

    M Mertl-Roetzer & F Lauster

  4. Centre of Neurological Rehabilitation, Magdeburg, Germany

    M Lerch

  5. Department of Internal Medicine, Herning County Hospital, Herning, Denmark

    J Eriksen

  6. Institute of Diabetes Research, Munich, Germany

    M Haslbeck

  7. Institute of Data Analysis and Study Design IDV, Gauting, Germany

    V W Rahlfs

Authors
  1. M Pohl
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  2. P Mayr
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  4. F Lauster
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  5. M Lerch
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  6. J Eriksen
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Corresponding author

Correspondence to M Pohl.

Additional information

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.

Appendices

Appendix A

Composition of the study diets is given in Tables A1, A2 and A3.

Table a1 Composition of the study diets (Part 1): Main nutrients
Full size table
Table a2 Composition of the study diets (Part 2): Vitamins and other nutrients
Full size table
Table a3 Composition of the study diets (Part 3): Minerals and trace elements
Full size table

Appendix B

Individual listing of all adverse events (AE) is given in Table B1.

Table 6 Table a4
Full size table

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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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