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OBES SURG (2008) 18:1400–1405DOI 10.1007/s11695-008-9500-4 Metabolic Outcomes of Obese Diabetic Patients FollowingLaparoscopic Adjustable Gastric Banding Rishi Singhal & Mark KitchenSue Bridgwater & Paul Super Received: 28 December 2007 / Accepted: 10 March 2008 / Published online: 26 April 2008 # Springer Science + Business Media, LLC 2008 improvement in their total cholesterol level. The mean Introduction Obesity is an independent risk factor in the arterial pressure improved in 87.5% of the patients.
development of diabetes. Weight loss surgery is the most Conclusion The metabolic syndrome associated with mor- effective treatment of morbid obesity. This study examines bid obesity is difficult to adequately control with medica- the effect of gastric banding on metabolic profile in tion. Laparoscopic gastric banding can be considered a potentially curative treatment option in the management of Methods Between April 2003 and November 2007, 1,335 patients underwent laparoscopic adjustable gastric banding.
Metabolic profile was examined on a subset of 254 patients.
Keywords Diabetes . Metabolic profile . Banding .
Of these, 122 were diabetic. Data collection included body mass index, weight, blood pressure, HbA1c, fastingglucose, total serum cholesterol, triglyceride, and medica-tions taken for blood pressure and diabetes both preoper- atively and 1 year postoperatively.
Results Comorbid conditions in the diabetic patients in- Obesity is an independent risk factor in the development of cluded hypercholesterolemia (49.3%), hypertriglyceridemia diabetes the severity of which rises with increasing (53.8%) and hypertension (92%). In 1 year, mean BMI excess weight []. The risk of atherosclerotic disease in reduced from 52.9 kg/m2 to 41.5 kg/m2. Of the patients, patients with diabetes based on 20 years of surveillance of 93.1% experienced an improvement in fasting glucose the Framingham cohort was increased by a factor of three levels and 75.4% patients an improvement in HbA1c levels There is evidence to support the claim that complica- at the end of 1 year. All patients experienced a decrease in tions of type 2 diabetes mellitus can be reduced with tight insulin requirements, and 36.6% were able to totally control of hyperglycemia []. Therapy with drugs alone in discontinue using it. Of the patients, 100% showed diabetes has a failure rate of 50% at the end of 3 years in improvement in their triglyceride level, and 90.9% showed maintaining target glycemic levels []. Current therapiesincluding diet, exercise, behavior modification, oral hypo-glycemic agents, and insulin rarely return patients to R. Singhal M. Kitchen S. Bridgwater P. Super euglycemia []. There remains therefore a great need to Upper GI Unit and Minimally Invasive Unit, find more effective ways of managing diabetes.
The role of weight loss in the control of Type 2 diabetes has been known for some time The role of surgery in the management of diabetes was first described in 1955 A systematic review by Buchwald [] in 2004 demonstrated 26 Lloyd Square, 16 Niall Close, Edgbaston, an improvement in diabetes which was dependent on the Birmingham B15 3LX, UKe-mail: singhal_rishi@rediffmail.com type of bariatric surgery performed, but in this review, studies reporting improvement in diabetes were limited in necessary and consequently seldom used for any of the sample size. Studies in the literature reporting the effect of laparoscopic banding on diabetes are scant and limited to All the patients received postoperative low-molecular- weight heparins and graduated compression stockingsduring the surgery. Immediate postoperative mobilizationand discharge on the same day or day following surgery was encouraged. Postoperatively, the patients were com-menced on oral fluids for 2–4 weeks followed by a soft All cases of laparoscopic banding performed between puree diet for a further 2 weeks. In most cases, normal band April 2003 and November 2007 in a single consultant unit diet was achieved at the end of 6 weeks. Fluoroscopy- at Heart of England NHS Foundation trust were included.
guided adjustments were performed at 2–3 and 5–6 months, These cases were either performed or were carried out and further fluoroscopic evaluations were performed only if under the supervision of a single surgeon. All the patients fulfilled the criteria for surgical treatment of obesity For follow up, the patients were seen initially at 6 weeks, (BMI ≥40 without comorbidities or BMI ≥35 with then every 3 months for the first 6 months, and every Data were collected from medical records, operation Data analysis was performed using Statistical package notes, and computer records. General practitioners for all for social services 13 (SPSS® Chicago, IL, USA). Tests patients who were identified as diabetic were contacted for performed included Mann–Whitney U test and Wilcoxon further data. Data collection included body mass index, signed ranks test. Spearman’s rho was used for nonpara- weight, blood pressure, HbA1c, glucose, total serum metric correlations. Statistical significance was accepted for cholesterol, triglyceride, and medications taken for blood a p value of ≤0.05. Values have been expressed as mean pressure and diabetes preoperatively and at 1 year follow- and range. The data set available at a particular time point up. All assays were performed in the laboratories at Heart has been indicated as number data available on/total of England NHS Foundation trust with internal and external patients, or patients who were on a particular drug. One- quality control. Ideal body weight was determined accord- year data have been expressed as number data available on/ ing to the Metropolitan Life Insurance Company’s 1983 height/weight tables ]. Percent of excess BMI loss wascalculated as recommended by Deitel et al. [Metabolicoutcomes were calculated for the diabetics at the end of1 year.
The following criteria were used to define diabetes: (1) fasting plasma glucose of >7.0 mmol/l, (2) random plasma glucose of >11.1 mmol/l, (3) ketonuria and clini-cally symptomatic. Impaired fasting glucose was defined as Between April 2003 and November 2007, 1,335 laparoscop- fasting plasma glucose 6.1 to 7.0 mmol/l; impaired glucose ic gastric band insertions were performed by the lead surgeon tolerance as an OGTT 2 hour glucose as ≥7.8 but <11.1; in two different hospitals. Of these, 254 patients were gestational diabetes defined as above, but occurring during operated at the Heart of England NHS Foundation trust, and this cohort has been considered for further analysis.
Hypertension was defined by a history of hypertension, The mean age of these patients was 44.8 years with a taking antihypertensive medication preoperatively, or if the range between 18 and 66. Of these patients, 191 (75.2%) patient had a persistent raised blood above 140/90 mmHg were females. The mean preoperative weight and BMI for as defined by UK National Institute for Clinical Excellence this subset was 146.3 kg (range 88–268 kg) and 52.5 kg/m2 (range 35.9–88), respectively. A mean excess weight of All the patients were admitted on the morning of the 83.2 kg was seen preoperatively in these patients with a operation. Pars flaccida technique was used for placement of all bands. The band was secured in place by the use of 3 The mean length of stay was 1.0 day (range 0–2 days) plicating sutures. The first was a gastropexy suture with an overall operative complication rate of 1.2% (three (Birmingham stitch), anchoring the fundus to the left crus.
patients). Two of these were in non-diabetic patients, one of The remaining two were of the gastro–gastro type ].
whom suffered an early band infection (band removed) and Three different bands were used for these procedures the other was found to have a band malposition (reposi- (Allergan Vanguard, Allergan AP large and Swedish bands).
tioned at 3 months). The single complication in a diabetic Use of a calibration tube and balloon was not considered patient was a band puncture, which presented at 8 months.
was 8.2 (range 4.9–13.3%; N=114/122). Mean glucose andHbA1c at 1 year were 6.9 mmol/l (N=101/114) and 7.4% There were 122 diabetics identified from this subset of 254 (N=101/114), respectively. These values were significantly patients. The mean age of these patients was 46.7 years different from the preoperative values (Wilcoxon signed (range 25–66). 81 (66.4%) were females. The mean ranks test, p<0.01). Of the patients, 93.1% experienced an preoperative weight and BMI for the diabetic patients was improvement in fasting glucose levels and 75.4% patients 151.8 kg (range 88–240 kg) and 52.9 kg/m2 (range 35.9– an improvement in HbA1c levels at the end of 1 year. The 81), respectively. A mean excess weight of 87.4 kg was %EWL did not have a significant effect on the decrease in seen preoperatively with a range between 36.1 and 169.7.
HbA1c levels (r=−0.28; p=0.149) and fasting glucose In comparison with the non-diabetics (N=132), statistically higher mean preoperative and excess weights were noticed Forty-two patients were on insulin with a mean daily in the diabetics with no statistical difference in their BMIs preoperative dose of 150.7 U. One-year insulin data were available for 41 patients. Fifteen had discontinued insulin Of these patients, 109 had Type 2 diabetes, 8 had im- (36.6%), 25 had their dose reduced, and 1 patient was on paired glucose tolerance, with 5 patients being diagnosed the same daily dose at the end of 1 year. The mean dose of with gestational diabetes. Eighty-two patients were on insulin for patients still on it at the end of 1 year was 37.2 U metformin, 42 on insulin, 13 on sulphonylureas, and 25 (Wilcoxon signed ranks test, p<0.01). The %EWL did not on thiazolidinediones. Associated conditions included hy- have a significant effect on the decrease in insulin levels at percholesterolemia (49.3%), hypertriglyceridemia (53.8%), the end of 1 year (r=0.299; p=0.176).
Preoperatively, 82 patients were on metformin with a mean dose of 2,026 mg. One-year data were available for Weight loss Excess percent BMI loss in these patients at 3, 77 patients. Twenty-six were able to discontinue metformin 6, and 12 months were 21.7 (19.6–23.9), 32.3 (26.5–38), (34.2%). Twenty-six had their dose reduced, 20 experi- and 37.8 (33–42.5), respectively. Excess percentage weight enced no change, and 5 patients had increase in the dose of loss at for the same time period was 19.7% (17.8–21.6), metformin. One patient was started on metformin during 39.4% (24.1–34.7), and 34.3% (29.8–38.7), respectively.
follow-up due to biochemical failure in the improvement There was no statistically significant difference with of diabetes. The mean dose of metformin for patients still regards to the weight loss between the diabetics (N=122) on it at the end of 1 year 1,589 mg (Wilcoxon signed ranks Thirteen patients were on sulphonylureas preoperatively with a mean dose of 116.9 mg. Three patients were able to discontinue these. The mean dose at the end of 1 year was60 mg (Wilcoxon signed ranks test; p=0.04). Twenty-five Hyperglycemia Mean preoperative glucose was 9.1 (range patients were on thiazolidinediones preoperatively. Thirteen 3.9–26.0 mmol/l; N=114/122). Mean preoperative HbA1c Table 1 Excess weight andBMI loss in diabetics vs.
Table 2 Metabolic profile of diabetics at the end of 1 year follow-up Values have been expressed as means±standard deviation. Number of patients with diabetes=122. The data set available at a particular time pointhas been indicated as (number data available on/ total patients, or patients who were on a particular drug). One-year data has been expressed asnumber data available on/patients who had preoperative data.
a Wilcoxon signed ranks test.
Dyslipidemia An elevated level of total serum cholesterol p<0.01). The Mean arterial pressure improved in 87.5% and serum trigylcerides was present in 49.3% and 53.8% of the patients, respectively. There was a reduction in total The %EWL did not have a significant effect on the serum cholesterol levels from a mean of 5.1 (N=98/122) to decrease in systolic (r=−0.051; p=0.812) and diastolic 4.4 (N=71/98) at the end of 1 year (Wilcoxon signed ranks (r=−0.282; p=0.182) blood pressure. This was also seen test, p=0.05). There was a change in serum triglyceride for the fall in mean arterial pressures (r=−0.171; p=0.425).
level from a mean of 3.9 (N=98/122) to 2.6 (N=71/98;Wilcoxon signed ranks test, p=0.007). Of the patients, Impaired glucose tolerance/gestational diabetes All 90.9% showed improvement in their total cholesterol level, patients with impaired glucose tolerance (N=8) experienced and 100% showed improvement in their serum triglyceride similar improvements in HbA1c, fasting glucose, dyslipi- levels. The %EWL did not have a significant effect on the demia, and hypertension. None of the patients had decrease in total cholesterol levels (r=0.347; p=0.399) and progression to type 2 diabetes. Similar results were also serum triglyceride (r=−0.347; p=0.399).
seen in the patients with gestational diabetes (N=5).
Hypertension Of the patients, 92.0% had either a history ofhypertension, were on anti-hypertensive medication, orwere found to be hypertensive at the time of surgery. The mean preoperative systolic and diastolic pressures were 148and 84 mmHg, respectively (N=122/122). At 1 year, they The effect of weight loss in the amelioration of diabetes is were 126 and 76 mmHg, respectively, (N = 115/122; well known The effect of laparoscopic gastric banding Wilcoxon signed ranks test; p<0.01, p<0.01). The mean on the metabolic profile in patients has been previously preoperative and 1 year Mean Arterial pressure were discussed in the literature. A recent 4-year study of obese 105.4 and 92.7, respectively (Wilcoxon signed ranks test, patients carried out by Pontiroli et al. found that no patients undergoing laparoscopic gastric banding progressed to type significant link between excess weight loss and the fall in II diabetes compared to 17% of those in the diet treatment arm []. They concluded that in morbid obesity, sustainedand long-lasting weight loss obtained through laparoscopic gastric banding prevents the occurrence of type II diabetes.
Similarly, Ferchak et al. have concluded that weight loss There was a statistically significant reduction in the sys- prevents progression from IGT to diabetes [ tolic, diastolic, and mean arterial pressures over the course One of the most recent articles on this subject by Dixon of 1 year. There was no significant link between excess et al. had similar conclusions. In this unblinded randomized weight loss and the reduction of these blood pressure controlled trial, the effect of gastric banding surgery vs medical therapy and weight loss by life style changes indiabetics was studied. The primary outcome measure wasremission of type 2 diabetes. Although a 76% remission of diabetes was found with gastric banding surgery, this studyonly included diabetics with a BMI between 30 and 40 and Laparoscopic gastric banding is obviously effective in with a relatively recent onset of diabetes [ producing weight loss over a 1-year period. Although a great Studies examining other comorbidities such as gastro- deal of research has been performed particularly focussing on esophageal reflux disease, asthma, dyslipidemia, hyperten- resolution of comorbidities with obesity surgery, studies spe- sion, depression, arthritis, joint and back pain, stress cifically examining comorbidity in diabetics undergoing gastric incontinence, and sleep apnea have observed similar banding are scant. In this study, a significant improvement in improvements with gastric banding surgery [, ].
diabetes and associated metabolic syndrome was observed.
Improvements in the metabolic profile of these diabetic obese patients appeared to be independent of the degree of weight loss,perhaps highlighting the pivotal role of calorie restriction rather A mean excess weight loss of 34.3% was noticed in the than absolute weight loss in this finding diabetics undergoing laparoscopic banding at the end of There were no significant complications in the diabetic 1 year compared to 38% by O’Brien et al. [However, the subset undergoing laparoscopic gastric banding emphasiz- mean preoperative weight and BMI of patients was much ing the low-risk nature of this treatment. These data support higher in our series, which could explain the lower excess the view that gastric banding is a safe intervention which weight loss , ]. There was no statistical difference in significantly impacts on the improvement and resolution of the amount of weight loss between the diabetics and type II diabetes and related metabolic syndrome in the non-diabetics, which is contrary to earlier published Improvement in all parameters of diabetes was noticed, and 1. Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH.
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