EDITORIAL

 

Diabetes surgery: minimum information on diabetic patients sample BMI 24-29 or BMI 30-34 for doing studies comparable

Cirugía diabetes: Información mínima sobre la muestra de pacientes IMC 24-29 ó IMC 30-34 para hacer estudios compatibles

 

 

M. Garciacaballero

Departamento de Cirugía. Facultad de Medicina. Málaga. Spain

 

 

In order to clarify the primary endpoint of our operations, when we use bariatric procedures for treating obesity, it is worldwide called Obesity Surgery. For identifying the bariatric surgery when it is primary used for treating Diabetes Mellitus (DM), I think we should call it Diabetes Surgery. In both cases we perform metabolic surgery.

DM is not a lineal and homogeneous disease. We have find patients with 37 years disease without metabolic syndrome (MS) nor diabetes complications, and other with only 5 years diagnosed disease already blind and 5 days/week dialysis. It could not be the same disease although we call always Diabetes Mellitus. Hence it is of maximum interest to be able to judge the effect of the different bariatric surgery procedures to have enough information on the diabetic patients included in the sample of the study.

Apart from C Peptidelevels and other parameters discussed in other chapter of this monographic issue, first distinction need to be, to differentiate between overweight patients (BMI 24-29) and already simple obese patients (BMI 30-34). Because simple obesity implies a preoperative excess weight of more than 20 kg and the consequences development of insulin resistance mechanism that could be the responsible of the type 2 diabetes mellitus. The elimination of this insulin resistance with the weight loss provoke by bariatric surgery, could already solve the problem without takes into account other mechanisms. While diabetic patients BMI < 30 that do not have so much excess weight and the consequent insulin resistance, it is more probable of having an important decrease of beta cells mass as responsible of their DM. So far, none of the studies or reviews that analyzed the results of bariatric surgery for treating DM in patients BMI < 35 does this distinction, considering both groups of patients equal for comparison.^1-4

The second important source of error is the proportion of non insulindependent and insulindependent number of patients of the population sample included in the study. Patients that need insulin for controlling the levels of glycemia translate pancreas deterioration, decrease beta cell mass and consequently reduced possibility of stimulating it by surgical gastrointestinal changes. While those that need only oral antidiabetic drugs for controlling their DM means that their pancreatic beta cell mass still produces enough insulin for maintaining the glycemic control, what means that it still exists a beta cell mass stimulable by surgical gastrointestinal changes that could explain their results.

Information on years of evolution of the disease as well as of years in treatment with insulin, speak on the aggressiveness of DM and/or resistance of beta-cell and other tissues to deterioration and, similarly, the possibility of success of the surgical gastrointestinal changes. None of studies published so far supply this kind of information.

We can argue in the same direction on the exact information about the accompanied comorbidities, as part of the metabolic syndrome, that presented preoperatively the patients including in the study population sample, and the resolution rate after surgical gastrointestinal changes. Although in this regard we can find more information especially on the postoperative resolution rate.

Very limited data, if some, is given on the specific diabetes complications (cardiopathy, retinopathy, nephropathy, neuropathy, peripheral vasculopathy, severe hypoglycemia episodes, etc) and the postoperative effect of the surgical gastrointestinal changes. Also very important information due to the limitations that they provoke for the everyday life of the patients and the great advantage that bring the surgery. And for having an idea if gastrointestinal surgery could also have an effect in their resolution. Especially taken into account that the most important part of the high costs of DM management are related to the treatment of its complications.⁵

Anyway, in our personal experience we have found many surprises in the evolution of patients after gastrointestinal bypass surgery (since February 2008 when we operate our first patient specific to treat DM by One Anastomosis Gastric Bypass (BAGUA) for treating diabetes that makes preoperative prediction of surgical results for solving DM really challenging.

This point is one more reason for describing the patient population sample with a minimum of clinical 1 data to be able to compare the results of different gastrointestinal surgical procedures used. Important will be also to analyse and give information on those cases in which the preoperative prediction do not correlate with the expected postoperative results.

In my opinion standardization of the remission criteria have not sense if we do not standardize first, an enough and exact information on the diabetic patient sample. That is the main reason why some studies produce unexpected good results^6,7 and could also explain the wide variability using the same procedure.^8-16 We can have 0% or 100% DM resolution rate (no necessity of diabetes treatment, basal glycemia < 125 mg/dl, HbAlc < 6,5 or 7%) depending from the patients we included in a study. Obviously the results need to be related with the clinical characteristics of the patient, and this is not the case at present.

The other data we need for comparison are on immediate postoperative complications and medium and long term effects of gastrointestinal surgical changes related to the degree of gastrointestinal symptoms and nutritive state. In this sense we can also incorporate data on quality of life before and after surgery using the specific test developed and validated in different languages for bariatric procedures.^17,18

 

References

1. Rubino F, Schauer PR, Kaplan LM, Cummings DE. Metabolic surgery to treat type 2 diabetes: clinical outcome and mechanisms of action. Annu Rev Med 2010; 61: 393-411.         [ Links ]

2. Fried M, Ribaric G, Buchwald JN, Svacina S, Dolezalova K, Scopinaro N. Metabolic surgery for the treatment of type 2 diabetes in patients with BMI < 35 kg/m²: An integrated review of early studies. Obes Surg 2010; 20: 776-790.         [ Links ]

3. Li Q, Chen L, Yang Z, Ye Z, Huang Y, He M, Zhang S, Feng X, Gong W, Zhang Z, Zhao W, Liu C, Qu S, Hu R. Metabolic effects of bariatric surgery in type 2 diabetic patients with body mass index < 35 kg/m². Diabetes Obes Metab 2012; 14: 262-70.         [ Links ]

4. Reis CE, Alvarez-Leite J, Bressan J, Alfenas RC. Role of Bariatric-Metabolic Surgery in the Treatment of Obese Type 2 Diabetes with Body Mass Index < 35: A Literature Review. Diabetes Technol Ther 2012; 14: 1.         [ Links ]

5. Proczko-Markuszewska M, Stefaniak T, Kaska L, Kobiela J, Sledzi ski Z. Impact of Roux-en-Y gastric bypass on regulation of diabetes type 2 in morbidly obese patients. Surg Endosc 2012; 26: 2202-7.         [ Links ]

6. O Brien PE, Dixon JB, Laurie C, Skinner S, Proietto J, McNeil J, Strauss B, Marks S, Schachter L, Chapman L, Anderson M. Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program. Ann Intern Med 2006; 144: 625-633.         [ Links ]

7. Parikh M, Duncombe J, Fielding GA: Laparoscopic adjustable gastric banding for patients with body mass index of 35 kg/m². Surg Obes RelatDis 2006; 2: 518-522.         [ Links ]

8. Cohen R, Pinheiro JS, Correa JL, Schiavon CA. Laparoscopic Roux-en-Y gastric bypass for BMI < 35 kg/m²: a tailored approach. Surg Obes Relat Dis 2006; 2: 401-404.         [ Links ]

9. Lee W, Wang W, Lee Y, Huang M, Ser KH, Chen JC. Effect of laparoscopic Mini-Gastric Bypass for type 2 diabetes mellitus: Comparison of BMI > 35 and < 35 kg/m². J Gastrointest Surg 2008; 12: 945-952.         [ Links ]

10. DeMaria EJ, Winegar DA, Pate VW, Hutcher NE, Ponce J, Pories WJ. Early postoperative outcomes of metabolic surgery to treat diabetes from sites participating in the ASMBS bariatric surgery center of excellence program as reported in the bariatric outcomes longitudinal database. Ann Surg 2010; 252: 559-567.         [ Links ]

11. Shah SS, Todkar JS, Shah PS, Cummings DE. Diabetes remission and reduced cardiovascular risk after gastric bypass in Asian Indians with body mass index < 35 kg/m². Surg Obes Relat Dis 2010; 6: 332-339.         [ Links ]

12. Huang CK, Shabbir A, Lo CH, Tai CM, Chen YS, Houng JY. Laparoscopic Roux-en-Y gastric bypass for the treatment of type II diabetes mellitus in Chinese patients with body mass index of 25-35. Obes Surg 2011; 21: 1344-1349.         [ Links ]

13. Lee WJ, Chong K, Chen CY, Chen SC, Lee YC, Ser KH, Chuang LM. Diabetes remission and insulin secretion after gastric bypass in patients with body mass index < 35 kg/m². Obes Surg 2011; 21: 889-895.         [ Links ]

14. Boza C, Muñoz R, Salinas J, Gamboa C, Klaassen J, Escalona A, Pérez G, Ibañez L, Guzmán S. Safety and efficacy of Roux-en-Y gastric bypass to treat type 2 diabetes mellitus in non-severely obese patients. Obes Surg 2011; 21: 1330-1336.         [ Links ]

15. De Sa VC, Ferraz AA, Campos JM, Ramos AC Araujo JG Jr, Ferraz EM.. Gastric bypass in the treatment of type 2 diabetes in patients with a BMI of 30 to 35 kg/m². Obes Surg 2011; 21: 283-287.         [ Links ]

16. Navarrete AS, Leyba Jl, Navarrete LLS, García Caballero M, Sánchez N, Pulgar V, Vivas A. Byapss gástrico en Y de Roux para el tratamiento de pacientes con diabetes mellitus tipo II con IMC entre 30 y 35 kg/m². Nutr Hosp 2012; 27 (4): 1144-1149.         [ Links ]

17. Korolija D, Sauerland S, Wood-Dauphinée S, Abbou CC, Eypasch E, Garciacaballero M, Lumsden MA, Millat B, Monson JR, Nilsson G,Pointner R, Schwenk W, Shamiyeh A, Szold A, Targarona E, Ure B, Neugebauer E; European Association for Endoscopic Surgery. Evaluation of quality of life after laparoscopic surgery: evidence-based guidelines of the European Association for Endoscopic Surgery. Surg Endosc 2004; 18: 879-97.         [ Links ]

18. Sauerland S, Weiner S, Hausler E, Dolezalova K, Angrisani L, Noguera CM, Garcíacaballero M, Immenroth M. Validity of the Czech, German, Italian, and Spanish version of the Moore-head-Ardelt II questionnaire in patients with morbid obesity. Obes Facts 2009; 2 (Suppl. 1): 57-62.2        [ Links ]