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

NCT03854981 | Unknown

• 1 other identifier: 18316
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bariatric Surgery Candidate

Keywords

Insulin Resistance; Cardiovascular Risk; Inflammation; Exercise; Diet

Outcome Measures

Primary Outcomes (1)

• Change in Insulin Resistance

  Mixed Meal Tolerance Test

  Through Study Completion, up to about 8 weeks

Secondary Outcomes (4)

• Change in Augmentation Index in %

  Through Study Completion, up to about 8 weeks

• Changes in Blood lipids in mg/dl

  Through Study Completion, up to about 8 weeks

• Length of Stay Post Surgery in minutes

  Up to 1 week

• Operating time in minutes

  Surgical Procedure

Other Outcomes (5)

• Changes in blood glucose in mg/dl

  Through Study Completion, up to about 8 weeks

• Changes in blood pressure in mmHg

  Through Study Completion, up to about 8 weeks

• Body weight and height will be combined to determine BMI in kg/m^2

  Through Study Completion, up to about 8 weeks

Study Arms (2)

Standard Care

PLACEBO COMPARATOR

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

Exercise + Standard Care

ACTIVE COMPARATOR

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; Procedure: Standard Care

Interventions

Exercise BEHAVIORAL

Subjects will be asked to exercise 5 days/week in addition to receiving standard care before bariatric surgery.

Exercise + Standard Care

Standard Care PROCEDURE

Standard preoperative care of bariatric surgery

Exercise + Standard Care; Standard Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 )

Sponsors & Collaborators

• University of Virginia: lead

Related Publications (14)

• Malin SK, Kashyap SR. Differences in Weight Loss and Gut Hormones: Rouen-Y Gastric Bypass and Sleeve Gastrectomy Surgery. Curr Obes Rep. 2015 Jun;4(2):279-86. doi: 10.1007/s13679-015-0151-1.

  PMID: 26627222 BACKGROUND

• Malin SK, Bena J, Abood B, Pothier CE, Bhatt DL, Nissen S, Brethauer SA, Schauer PR, Kirwan JP, Kashyap SR. Attenuated improvements in adiponectin and fat loss characterize type 2 diabetes non-remission status after bariatric surgery. Diabetes Obes Metab. 2014 Dec;16(12):1230-8. doi: 10.1111/dom.12376. Epub 2014 Sep 14.

  PMID: 25132119 BACKGROUND

• Shada AL, Hallowell PT, Schirmer BD, Smith PW. Aerobic exercise is associated with improved weight loss after laparoscopic adjustable gastric banding. Obes Surg. 2013 May;23(5):608-12. doi: 10.1007/s11695-012-0826-6.

  PMID: 23196991 BACKGROUND

• Coen PM, Tanner CJ, Helbling NL, Dubis GS, Hames KC, Xie H, Eid GM, Stefanovic-Racic M, Toledo FG, Jakicic JM, Houmard JA, Goodpaster BH. Clinical trial demonstrates exercise following bariatric surgery improves insulin sensitivity. J Clin Invest. 2015 Jan;125(1):248-57. doi: 10.1172/JCI78016. Epub 2014 Dec 1.

  PMID: 25437877 BACKGROUND

• Khanna V, Malin SK, Bena J, Abood B, Pothier CE, Bhatt DL, Nissen S, Watanabe R, Brethauer SA, Schauer PR, Kirwan JP, Kashyap SR. Adults with long-duration type 2 diabetes have blunted glycemic and beta-cell function improvements after bariatric surgery. Obesity (Silver Spring). 2015 Mar;23(3):523-6. doi: 10.1002/oby.21021. Epub 2015 Feb 3.

  PMID: 25651277 BACKGROUND

• Mechanick JI, Youdim A, Jones DB, Garvey WT, Hurley DL, McMahon MM, Heinberg LJ, Kushner R, Adams TD, Shikora S, Dixon JB, Brethauer S; American Association of Clinical Endocrinologists; Obesity Society; American Society for Metabolic & Bariatric Surgery. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient--2013 update: cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery. Obesity (Silver Spring). 2013 Mar;21 Suppl 1(0 1):S1-27. doi: 10.1002/oby.20461.

  PMID: 23529939 BACKGROUND

• Malin SK, Niemi N, Solomon TP, Haus JM, Kelly KR, Filion J, Rocco M, Kashyap SR, Barkoukis H, Kirwan JP. Exercise training with weight loss and either a high- or low-glycemic index diet reduces metabolic syndrome severity in older adults. Ann Nutr Metab. 2012;61(2):135-41. doi: 10.1159/000342084.

  PMID: 23036993 BACKGROUND

• Malin SK, Haus JM, Solomon TP, Blaszczak A, Kashyap SR, Kirwan JP. Insulin sensitivity and metabolic flexibility following exercise training among different obese insulin-resistant phenotypes. Am J Physiol Endocrinol Metab. 2013 Nov 15;305(10):E1292-8. doi: 10.1152/ajpendo.00441.2013. Epub 2013 Sep 24.

  PMID: 24064339 BACKGROUND

• Nakamura K, Fuster JJ, Walsh K. Adipokines: a link between obesity and cardiovascular disease. J Cardiol. 2014 Apr;63(4):250-9. doi: 10.1016/j.jjcc.2013.11.006. Epub 2013 Dec 16.

  PMID: 24355497 BACKGROUND

• Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.

  PMID: 15616203 BACKGROUND

• Schauer PR, Burguera B, Ikramuddin S, Cottam D, Gourash W, Hamad G, Eid GM, Mattar S, Ramanathan R, Barinas-Mitchel E, Rao RH, Kuller L, Kelley D. Effect of laparoscopic Roux-en Y gastric bypass on type 2 diabetes mellitus. Ann Surg. 2003 Oct;238(4):467-84; discussion 84-5. doi: 10.1097/01.sla.0000089851.41115.1b.

  PMID: 14530719 BACKGROUND

• Malin SK, Finnegan S, Fealy CE, Filion J, Rocco MB, Kirwan JP. beta-Cell dysfunction is associated with metabolic syndrome severity in adults. Metab Syndr Relat Disord. 2014 Mar;12(2):79-85. doi: 10.1089/met.2013.0083. Epub 2013 Nov 27.

  PMID: 24283920 BACKGROUND

• Liu B, Kuang L, Liu J. Bariatric surgery relieves type 2 diabetes and modulates inflammatory factors and coronary endothelium eNOS/iNOS expression in db/db mice. Can J Physiol Pharmacol. 2014 Jan;92(1):70-7. doi: 10.1139/cjpp-2013-0034. Epub 2013 Oct 21.

  PMID: 24383875 BACKGROUND

• Yassine HN, Marchetti CM, Krishnan RK, Vrobel TR, Gonzalez F, Kirwan JP. Effects of exercise and caloric restriction on insulin resistance and cardiometabolic risk factors in older obese adults--a randomized clinical trial. J Gerontol A Biol Sci Med Sci. 2009 Jan;64(1):90-5. doi: 10.1093/gerona/gln032. Epub 2009 Jan 20.

  PMID: 19164269 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance; Inflammation; Motor Activity

Interventions

Exercise; Standard of Care

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Steven K Malin

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 26, 2019
• Study Start: August 11, 2015
• Primary Completion: January 22, 2019
• Study Completion: May 1, 2020
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share