Clinical trial NCT03854981: Pre-operative Exercise and Nutrition Therapy on Cardio-metabolic Health in Patients Undergoing Bariatric Surgery
Official title: Role of Pre-operative Exercise and Nutrition Therapy on Insulin Resistance and Vascular Health in Patients Undergoing Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery Candidate
Keywords: Insulin Resistance
Cardiovascular Risk
Inflammation
Exercise
Diet
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in Insulin Resistance
timeFrame: Through Study Completion, up to about 8 weeks
Secondary outcomes:
measure: Change in Augmentation Index in %
timeFrame: Through Study Completion, up to about 8 weeks
measure: Changes in Blood lipids in mg/dl
timeFrame: Through Study Completion, up to about 8 weeks
measure: Length of Stay Post Surgery in minutes
timeFrame: Up to 1 week
measure: Operating time in minutes
timeFrame: Surgical Procedure
Other outcomes:
measure: Changes in blood glucose in mg/dl
timeFrame: Through Study Completion, up to about 8 weeks
measure: Changes in blood pressure in mmHg
timeFrame: Through Study Completion, up to about 8 weeks
measure: Body weight and height will be combined to determine BMI in kg/m^2
timeFrame: Through Study Completion, up to about 8 weeks
measure: Concentration of adiponectin in pg/mg
timeFrame: Surgical Procedure
measure: Concentration of leptin in pg/mg
timeFrame: Surgical Procedure
Locations:
Study officials:
affiliation: University of Virginia
name: Steven K Malin
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
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