Pre-operative Exercise and Nutrition Therapy on Cardio-metabolic Health in Patients Undergoing Bariatric Surgery

Study Overview
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Brief Summary
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Obesity is a major health concern that has been associated with an estimated 2.8 million deaths worldwide each year. The number of individuals considered obese with a Body Mass Index (BMI) above 30 kg/m2 has grown to more than 500 million. The increased morbidity and mortality associated with obesity stems from a long list of comorbidities, including hypertension, coronary artery disease, stroke, cancer, and type 2 diabetes (T2D). Bariatric surgery is an emerging intervention that has been used frequently to induce weight loss for obese individuals and it has been shown to improve glycemic control and insulin resistance in people at risk for type 2 diabetes. Surgery may also lead to healthy improvements in inflammation, immune cells and vascular health. It is already known that exercise and weight loss from lifestyle modification can improve glycemic control, insulin resistance, inflammation, and arterial stiffness. However, no work has been done to examine a combination of bariatric surgery and pre-surgery exercise. Recent work by the team has evidence demonstrating that health status pre-surgery has an impact on post-surgery outcomes. Such findings suggest that improvements in health status from exercise before surgery may improve surgery outcomes as well as surgery-induced health outcomes. To date, no study has systematically examined the role of exercise on the prevalence of surgery complications or on post-surgery weight loss, glycemic control, and insulin resistance. Moreover, no work currently exists on exercise, with or without bariatric surgery on adipose tissue derived inflammation. Therefore, the purpose of this study is to investigate the effect of pre-surgery lifestyle intervention with exercise on bariatric surgery outcomes. To test this objective, subjects will participate in a match paired study, based on BMI. Subjects will undergo testing of blood chemistry and related measures of health before (pre-test) and after (post) intervention. Then all subjects will receive bariatric surgery. Post surgery outcomes will be assessed by examining surgery operating time, changes in blood chemistry, adipose tissue biopsies and other measures indicative of glucose and vascular health. After this surgery, subjects will return for testing about 30d later.

Official Title
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Role of Pre-operative Exercise and Nutrition Therapy on Insulin Resistance and Vascular Health in Patients Undergoing Bariatric Surgery

Conditions
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Bariatric Surgery Candidate

Intervention / Treatment
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* Behavioral: Exercise
* Procedure: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and Females, 18-70 years of age BMI >30 and <70 kg/m2 Sedentary (Not currently participating in exercise training: >30 min. of physical activity per day, >3 days/week) HCT for women > 36%, Men >38% Non-pregnant (women).-self reported Smoker (if bariatric surgery patient) or non-smoker (enrolled for the dietary portion of the study) Has the ability/willingness to participate in the study and agree to any of the arms involved in the study. No prior surgical procedure for obesity with the exception of a laparoscopic adjustable gastric banding (LAGB) under the condition that the band had not been adjusted in less than or equal to 1 year Exclusion Criteria: Currently participating in exercise training: >30 min. of physical activity per day, >2 days/week) Cigarette smoking (presently or in the past 6 months), drug or alcohol abuse Pregnancy or breastfeeding History of congestive heart failure, ischemic heart disease, severe pulmonary disease. History of cancer (within 5 years) Diagnosed as insulin-dependent diabetes. Change in psychotropic medication dosage in past six weeks AST or ALT > 3 times normal range Currently involved in any active weight loss treatment program (other than self-directed attempt at calorie restricting diet) or lean patients (BMI <29 kg/m2). Current purging behavior occurring > once a week over the past six weeks (self-induced vomiting for weight control purposes, laxative or diuretic abuse) Revisional bariatric procedures including a RYGB reversal to a SG or a LAGB revision to a SG or RYGB if the band has been adjusted in greater than or equal to 1 year. Active psychotic illness, including bipolar affective disorders. Evidence of current suicidality or homicidality Conditions associated with significant cognitive dysfunction (e.g. dementia) or medical instability that puts the participant at risk Contraindication to exercise (severe/uncontrolled CVD; inability to walk 2 blocks, bone or joint problems ) Allergy to caine family drugs (e.g. lidocaine). Currently taking active weight suppression medication (e.g. phentermine,bupropion SR, topiramate). On medication known to cause substantial weight gain (e.g. atypical antipsychotics such as olanzapine, sodium valproate, steroid therapy). This would not include medications commonly used in this population that usually result in only mild weight loss (e.g. SSRIs).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard Care<br>If subjects are assigned to this group they will not be provided materials to increase exercise participation. Subjects will however be asked to participate in the standard education sessions that are provided to all bariatric surgery patients. This standard care includes meetings with a nutritionist, psychologist, and bariatric surgeon. | Procedure: Standard Care<br>* Standard preoperative care of bariatric surgery<br>|
| Active Comparator: Exercise + Standard Care<br>Subjects will be asked to exercise 5 days/week for 30 min/day at an intensity of 65-85% of their measured HRmax. Walking will be the main type of exercise. In addition to this training program, subject's will participate in the standard education sessions that are provided to all bariatric surgery patients. | Behavioral: Exercise<br>* Subjects will be asked to exercise 5 days/week in addition to receiving standard care before bariatric surgery.<br>Procedure: Standard Care<br>* Standard preoperative care of bariatric surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insulin Resistance | Mixed Meal Tolerance Test | Through Study Completion, up to about 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Augmentation Index in % | Arterial Stiffness | Through Study Completion, up to about 8 weeks | 
| Changes in Blood lipids in mg/dl | Cholesterol and triglycerides | Through Study Completion, up to about 8 weeks | 
| Length of Stay Post Surgery in minutes | Recovery from surgery | Up to 1 week | 
| Operating time in minutes | Length of Surgery | Surgical Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin Resistance, Cardiovascular Risk, Inflammation, Exercise, Diet