Four-hour evaluation of a medical food in subjects with type 2 diabetes receiving oral hypoglycemic medication

Menghua Luo, Anne C. Voss, Vikkie A. Mustad, Lyudmila Ivanova, Tatiana Morugova, Elena Alexeeva, Lyudmila Ruyatkina, Lyudmila Suplotova

Abbott Nutrition, Columbus, USA.
Bashkir State Medical University Based on City Clinical Hospital #21, Ufa, Russia.
Kuban State Medical University Based on City Clinical Hospital of Emergency Care, Krasnodar, Russia.
Novosibirsk State Medical University Based on City Clinical Hospital #1, Novosibirsk, Russia.
Russian State Medical University of Federal Agency of Healthcare and Social Development Based on City Clinical Hospital #68, Moscow, Russia.
Tyumen State Medical Academy, Tyumen, Russia.

DOI: 10.4236/jdm.2012.22034                

Abstract

Background: Postprandial hyperglycemia is an independent risk factor for diabetes-associated complications in individuals with type 2 diabetes. Dietary modification plays an important role in glycemic control. This study was to examine the efficacy of a diabetes specific formula (DSF) during a 4-hour postprandial meal tolerance test (MTT) in Russian subjects with type 2 diabetes receiving oral hypoglycemic medication. Methods: In a randomized, cross-over design, 168 eligible subjects from 11 study centers consumed, in a random order, the DSF (230 mL) or a common light hospital breakfast (i.e. standard meal) on two different occasions. The amounts of macronutrients were similar between the two meals providing ~200 kcal, 11 g protein, 26 g carbohydrate and 8 g fat. Capillary glucose levels were measured at baseline (before meal consumption), and post-meal consumption at 30, 60, 90, 120, 180 and 240 min. Results: The DSF was well tolerated in all subjects. There were 111 subjects completed the study per protocol (mean ± SEM: age: 58.6 ± 0.8 yr, BMI: 31.8 ± 0.42 kg/m2, waist circumference: 101 ± 1.3 cm, HbA1c: 8.0% ± 0.1%). Glucose levels reached peak values at 60 min (median) and the lowest levels at the end of the 240-min MTT test. The mean positive area under the curve (PAUC), the primary outcome, was significantly smaller after DSF consumption (mean ± SEM: 183.02 ± 18.74, median: 132.55) than the PAUC after consumption of the standard meal (mean ± SEM: 239.95 ± 23.11, median: 166.89; p = 0.027). The actual and adjusted peak glucose concentrations were similar between the two treatments. Conclusions: In patients with type 2 diabetes receiving oral hypoglycemic agents, compared to a hospital meal, the DSF improves postprandial glucose control. Combining results from earlier studies, long-term use of DSF may be beneficial to improve glucose management and decrease diabetes-associated complications.

Keywords

Type 2 Diabetes; Diabetes Specific Formula; Glucose Control

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1]	Wild, S., Roglic, G., Green, A., Sicree, R. and King, H. (2004) Global prevalence of diabetes: Estimates for the year 2000 and projections for 2030. Diabetes Care, 27, 1047-1053. doi:10.2337/diacare.27.5.1047
[2]	Diabetes Atlas. (2009) International Diabetes Federation. http://www.eatlas.idf.org/index1397.html.
[3]	The Diabetes Control and Complications Trial Research Group. (1993) The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The New England Journal of Medicine, 329, 977-986. doi:10.1056/NEJM199309303291401
[4]	UK Prospective Diabetes Study (UKPDS) Group. (1998) Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). The Lancet, 352, 837-853. doi:10.1016/S0140-6736(98)07019-6
[5]	Ceriello, A. and Colagiuri, S. (2008) International Diabetes Federation guideline for management of postmeal glucose: A review of recommendations. Diabetes Medicine, 25, 1151-1156. doi:10.1111/j.1464-5491.2008.02565.x
[6]	Woerle, H.J., Neumann, C., Zschau, S., Tenner, S., Irsigler, A., Schirra, J., et al. (2007) Impact of fasting and postprandial glycemia on overall glycemic control in type 2 diabetes importance of postprandial glycemia to achieve target HbA1c levels. Diabetes Research Clinical Practice, 77, 280-285. doi:10.1016/j.diabres.2006.11.011
[7]	Pastors, J.G., Warshaw, H., Daly, A., Franz, M. and Kulkarni, K. (2002) The evidence for the effectiveness of medical nutrition therapy in diabetes management. Diabetes Care, 25, 608-613. doi:10.2337/diacare.25.3.608
[8]	Sun, J., Wang, Y., Chen, X., Chen, Y., Feng, Y., Zhang, X., et al. (2008) An integrated intervention program to control diabetes in overweight Chinese women and men with type 2 diabetes. Asia Pacific Journal of Clinical Nutrition, 17, 514-524.
[9]	Climt, C.R., Prout, T.E., Bradley, R.F., Dolger, H., Fisher, G., Gastineau, C.F., et al. (1969) Standardization of the oral glucose tolerance test. Diabetes, 18, 299-307.
[10]	Wolever, T.M., Jenkins, D.J., Jenkins, A.L. and Josse, R.G. (1991) The glycemic index: Methodology and clinical implications. American Journal of Clinical Nutrition, 54, 846-854.
[11]	Via, M.A. and Mechanick, J.I. (2011) Inpatient enteral and parenteral (corrected) nutrition for patients with diabetes. Current Diabetes Reports, 11, 99-105. doi:10.1007/s11892-010-0168-5
[12]	Gonzalez-Ortiz, M., Martinez-Abundis, E., Hernandez-Salazar, E., Kam-Ramos, A.M. and Robles-Cervantes, J.A. (2006) Effect of a nutritional liquid supplement designed for the patient with diabetes mellitus (Glucerna SR) on the postprandial glucose state, insulin secretion and insulin sensitivity in healthy subjects. Diabetes Obesity Metabolism, 8, 331-335. doi:10.1111/j.1463-1326.2005.00512.x
[13]	Coulston, A.M. (1998) Clinical experience with modified enteral formulas for patients with diabetes. Clinical Nutrition, 17, 46-56. doi:10.1016/S0261-5614(98)80017-4
[14]	McCargar, L.J., Innis, S.M., Bowron, E., Leichter, J., Dawson, K., Toth, E. and Wall, K. (1998) Effect of enteral nutritional products differing in carbohydrate and fat on indices of carbohydrate and lipid metabolism in patients with NIDDM. Molecular Cellular Biochemistry, 188, 81-89. doi:10.1023/A:1006872506658
[15]	Bantle, J.P., Wylie-Rosett, J., Albright, A.L., Apovian, C.M., Clark, N.G., Franz, M.J., et al. (2008) Nutrition recommendations and interventions for diabetes: A position statement of the American Diabetes Association. Diabetes Care, 31, S61-S78. doi:10.2337/dc08-S061
[16]	Boj-Carceller, D., Bocos-Terraz, P., Moreno-Vernis, M., Sanz-Paris, A., Trincado-Aznar, P. and Albero-Gamboa, R. (2011) Are proton pump inhibitors a new antidiabetic drug? A cross sectional study. World Journal of Diabetes, 2, 217-220. doi:10.4239/wjd.v2.i12.217
[17]	Monnier, L. and Colette, C. (2006) Contributions of fasting and postprandial glucose to hemoglobin A1c. Endocrine Practice, 12, 42-46.
[18]	Stolar, M. (2010) Glycemic control and complications in type 2 diabetes mellitus. American Journal of Medicine, 123, S3-S11. doi:10.1016/j.amjmed.2009.12.004
[19]	Nuttall, F.Q., Gannon, M.C., Burmeister, L.A., Lane, J.T. and Pyzdrowski, K.L. (1992) The metabolic response to various doses of fructose in type II diabetic subjects. Metabolism, 41, 510-517. doi:10.1016/0026-0495(92)90210-2
[20]	Wolf, B.W., Humphrey, P.M., Hadley, C.W., Maharry, K.S., Garleb, K.A. and Firkins, J.L. (2002) Supplemental fructose attenuates postprandial glycemia in Zucker fatty fa/fa rats. Journal of Nutrition, 132, 1219-1223.
[21]	Wakabayashi, S., Kishimoto, Y. and Matsuoka, A. (1995) Effects of indigestible dextrin on glucose tolerance in rats. Journal of Endocrinology, 144, 533-538. doi:10.1677/joe.0.1440533
[22]	Lichtenstein, A.H., Appel, L.J., Brands, M., Carnethon, M., Daniels, S., Franch, H.A., et al. (2006) Diet and lifestyle recommendations revision 2006: A scientific statement from the American Heart Association Nutrition Committee. Circulation, 114, 82-96. doi:10.1161/CIRCULATIONAHA.106.176158
[23]	Sanz-Paris, A., Calvo, L., Guallard, A., Salazar, I. and 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. doi:10.1016/S0899-9007(98)00124-5
[24]	West, S.G., Hecker, K.D., Mustad, V.A., Nicholson, S., Schoemer, S.L., Wagner, P., Hinderliter, A.L., Ulbrecht, J., Ruey, P. and Kris-Etherton, P.M. (2005) Acute effects of monounsaturated fatty acids with and without omega-3 fatty acids on vascular reactivity in individuals with type 2 diabetes. Diabetologia, 48, 113-122. doi:10.1007/s00125-004-1600-7