To determine if surgically induced weight loss resulted in improved glycemic control and lessened the need for diabetes medication, compared to conventional approaches to weight loss and diabetes management.

• Patients in this study were between 20 and 60 years of age and their body mass index (BMI) varied from 30 to 40kg per m²
• Patients had a recent (less than two years) Type 2 diabetes diagnosis and did not show any signs of kidney disease or retina complications
• Patients were able to understand and comply with the study procedures.

• Candidates were excluded if they had:
  • Type 1 diabetes
  • Diabetes secondary to a disease
  • Previous bariatric surgery
  • History of medical or mental problems
  • Drug or alcohol addiction/abuse
  • Recent vascular events
  • Cancer
  • Portal hypertension. 
• Patients were also excluded if they did not attend two initial information appointments.  

Recruitment

• Newspaper advertisements
• Participants were not paid to participate.

Design

Randomized controlled trial.

Blinding Used

• None.  However, both the patients and the health care professionals knew which research group the participants were in. 
• Prior to the beginning of the study, an independent endocrinologist determined when the patients were ready for randomization, based on their baseline clinical data.

Intervention
Two treatment groups: 

• Group 1 received conventional, intensive advice from a general physician, dietitian, nurse and diabetes educator every six weeks for two years. Medical therapy was determined by an experienced diabetes professional on a case-by-case basis. Physical activity recommendations, dieting plans and diabetes medications were available to patients to help them achieve their goals.
• Group 2 patients had surgery via laparoscopic adjustable bands. The patients were monitored for progress by a bariatric team every four to six weeks for the entire study period and adjustments were made to their band volume, based on individual need. These patients also received lifestyle and dietary advice on an as needed basis. 

Statistical Analysis

• Chi-square procedures for proportion, T-tests for differences or Mann-Whitney U tests were done on the data 
• Multivariate longitudinal analysis was performed to assess weight and biochemical changes over time. 

• Timing of measurements: Baseline and at every four to six week interval for two years between both study group participants 
• Dependent variables:
  • Glycemic control
  • Diabetes medication and non-diabetes medication usage
  • Weight changes
  • Diabetes remission rate
  • Various metabolic measurements (blood lipids, blood pressure, waist measurements).
• Independent variables: Lap band surgery with lifestyle advice (as needed) vs. aggressive, intensive, regular lifestyle advice.

• Initial N: 60 total (28 males, 32 females)
• Attrition (final N): 55% or 92% retention and study completion rate
• Average age: 46.6 years in the surgical group (SD 7.4 years); 47.1 years in the conventional therapy groups (SD 8.7 years)
• Ethnicity: Australian adults
• Other relevant demographics: All the participants were willing and able to comply to study protocol
• Anthropometrics: Both groups were the same on important outcome measures including age, health status, BMI, metabolic management of glucose, blood lipids and body size dimensions
• Location: Center for Obesity Research and Education and Department of Epidemiology and Preventive Medicine, Melbourne, Australia and the University of Melbourne.

Glycemic Control

• Mean levels of HbA1c were significantly lower in the surgical group at two years (P<0.001)
• 24 of the surgical group patients had achieved acceptable HbA1c levels post-two years compared to only six of the conventionally treated patients.

Use of Diabetes Medication

• There was a significant reduction in the use of diabetes medication for gylcemic control among the surgically treated patients
• After two years post-surgery, 26 of the surgically treated patients vs. eight of the conventionally treated patients were drug-free regarding glycemic management
• A few patients in the surgical group continued to use metformin or other hypoglycemic drugs
• There was no significant decrease in the usage of drug therapy for diabetes management in the conventionally treated group. Several patients in this group continued to use metformin, other oral hypoglycemic agents or even insulin after two years of intensive, conventional lifestyle management.

Use of Non-Diabetes Medication

• The surgically treated group used significantly less blood pressure management (P<0.001) and lipid lowering medicine (P<0.02) compared to the conventionally treated group
• The subjects in the conventionally treated group observed no difference in the use of their medicine to treat these conditions.

Weight Change

• The surgical group achieved a mean 20% body weight loss compared with only 1.4% body weight loss for the conventionally treated group (P<0.001)
• In addition, the surgical group continued to lose weight over time and the differences between the groups increased as time went by during this two-year study
• The subjects in the surgical group observed a reduction of BMI from a mean of 36.9 to a mean of 29.5, compared with a minimal reduction from 37.1 to 36.6 in the conventionally treated group.

Diabetes Remission Rate

• Diabetes remission was more likely to occur among the surgical patients
• The remission rate of the surgical patients was 76% and it was 15% in the conventional therapy group
• Greater percentages of weight loss and lower baseline HbA1c values were associated with the diabetes remission in the surgically treated patients. 

Various Metabolic Measurements

• The surgical group had a greater improvement after two years in insulin sensitivity, triglycerides and HDL-C compared to the conventional group
• The reduction in the diagnosis of metabolic syndrome was also significant in the surgical group (P<0.001)
• Both groups had 29 out of 30 patients which had this diagnosis at baseline
• After two years, only eight out of 29 in the surgical group still had the diagnosis, whereas 26 out of 29 continued to have the metabolic syndrome diagnosis with conventional treatment. 

• This was a powerful study that illustrated the value of gastric binding surgery on early treatment and care of obese individuals with Type 2 diabetes
• Although the results do not apply to every patient with Type 2 diabetes, it certainly have profound implications for this group
• Weight loss associated with banding procedures produces benefits above and beyond the weight loss. These include better glycemic management, lipid control, fewer prescription drugs and better metabolic management.

• The authors in this study were extremely honest and straightforward about the limitations of the study and the inability to know for sure, if these favorable outcomes could be seen among patients with long-standing diabetes, Type 1 diabetes, etc. 
• Several study limitations were discussed at the end of the article and the authors were very forthcoming about the details of their study.