Effect of weight reducing surgery on diabetes and the heart

Not Applicable

• Conditions: Obesity; type 2 diabetes; Metabolic and Endocrine - Diabetes; Diet and Nutrition - Obesity

• Registration Number: ACTRN12609000679280
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.patients with type 2 diabetes or impaired glucose tolerance planned to have gastric bypass surgery at Auckland hospital
2.patients with type 2 diabetes or impaired glucose tolerance planned to have gastric sleeve resection at Middlemore hospital
3.Patients with type 2 diabetes or impaired glucose tolerance planned to have elective laparoscopic cholecystectomy (will required to be matched for BMI and age for cases in study)

Exclusion Criteria

1.Age <18, or >70
2.BMI < 35 kg/m2
3.Cardiovascular conditions including significant coronary artery disease, congestive heart failure
4.Severe pulmonary disease
5.Previous bariatric/gastric/small bowel operation.
6.Underlying endocrinology disorder or genetic syndrome related to obesity and secondary diabetes.
7.Steroid dependence
8.Exenatide treatment within 3 months of surgery
9.Previous surgery to pancreas, or other pancreatic pathology
10.Pregnant women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
blood tests after oral glucose: analysis of glucagon-like peptide 1 (GLP-1), ghrelin, glucagon, free fatty acids, glucose, insulin, C peptide[3 days before surgery, 3 days after surgery, 3 months after surgery, 6 months after surgery.];continuous glucose monitoring in the perioperative phase using a continuous blood glucose monitor[from morning of surgery until day of discharge or day 6 post surgery (whichever occurs earlier)];anthropometric data - height, weight, body mass index (BMI), hip waist circumference ratio. Blood pressure[3 days before surgery, 3 days after surgery, 3 months after surgery, 6 months after surgery.]

Secondary Outcome Measures

Name	Time	Method
metabolic risk factors:<br><br>by blood analysis: sensitive C-reactive protein (CRP), urate, lipids, Haemoglobin A1c (HbA1c), <br><br>urine analysis: to test for urine microalbumin[3 days before surgery, 3 days after surgery, 3 months after surgery, 6 months after surgery.];Quality of life assessment using Impact of Weight on Quality of Life-Lite (IWQOL-lite) questionnaire[3 days before surgery, 3 days after surgery, 3 months after surgery, 6 months after surgery.];simple calorimetry to assess energy expenditure[3 days before surgery, 3 days after surgery, 3 months after surgery, 6 months after surgery.];body composition analysis to assess fat and lean muscle mass using whole body dual X-ray absorptiometry[3 days before surgery, 3 days after surgery, 3 months after surgery, 6 months after surgery.]