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

February 23, 2019 updated by: Steven K. Malin, PhD, University of Virginia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Standard Care
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
Standard preoperative care of bariatric surgery
Active Comparator: Exercise + Standard Care
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.
Procedure: Standard Care
Standard preoperative care of bariatric surgery
Behavioral: Exercise
Subjects will be asked to exercise 5 days/week in addition to receiving standard care before bariatric surgery.

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in blood glucose in mg/dl
Time Frame: Through Study Completion, up to about 8 weeks
For the Mixed Meal Tolerance Test
Through Study Completion, up to about 8 weeks
Changes in blood pressure in mmHg
Time Frame: Through Study Completion, up to about 8 weeks
At the Mixed Meal Tolerance Test
Through Study Completion, up to about 8 weeks
Body weight and height will be combined to determine BMI in kg/m^2
Time Frame: Through Study Completion, up to about 8 weeks
At the Mixed Meal tolerance Test
Through Study Completion, up to about 8 weeks
Concentration of adiponectin in pg/mg
Time Frame: Surgical Procedure
From adipose biopsy
Surgical Procedure
Concentration of leptin in pg/mg
Time Frame: Surgical Procedure
From adipose biopsy
Surgical Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Steven K Malin, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2015

Primary Completion (Actual)

January 22, 2019

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

February 23, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 23, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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