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

Primary Purpose

Bariatric Surgery Candidate

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Exercise

Standard Care

About this trial

This is an interventional supportive care trial for Bariatric Surgery Candidate focused on measuring Insulin Resistance, Cardiovascular Risk, Inflammation, Exercise, Diet

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Standard Care

Exercise + Standard Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Insulin Resistance

Mixed Meal Tolerance Test

Secondary Outcome Measures

Change in Augmentation Index in %

Arterial Stiffness

Changes in Blood lipids in mg/dl

Cholesterol and triglycerides

Length of Stay Post Surgery in minutes

Recovery from surgery

Operating time in minutes

Length of Surgery

Full Information

NCT ID

NCT03854981

First Posted

January 24, 2019

Last Updated

February 23, 2019

Sponsor

University of Virginia

1. Study Identification

Unique Protocol Identification Number

NCT03854981

Brief Title

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

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 11, 2015 (Actual)

Primary Completion Date

January 22, 2019 (Actual)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bariatric Surgery Candidate

Keywords

Insulin Resistance, Cardiovascular Risk, Inflammation, Exercise, Diet

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Care

Arm Type

Placebo Comparator

Arm Description

Arm Title

Exercise + Standard Care

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Standard Care

Intervention Description

Standard preoperative care of bariatric surgery

Primary Outcome Measure Information:

Title

Change in Insulin Resistance

Description

Mixed Meal Tolerance Test

Time Frame

Through Study Completion, up to about 8 weeks

Secondary Outcome Measure Information:

Title

Change in Augmentation Index in %

Description

Arterial Stiffness

Time Frame

Through Study Completion, up to about 8 weeks

Title

Changes in Blood lipids in mg/dl

Description

Cholesterol and triglycerides

Time Frame

Through Study Completion, up to about 8 weeks

Title

Length of Stay Post Surgery in minutes

Description

Recovery from surgery

Time Frame

Up to 1 week

Title

Operating time in minutes

Description

Length of Surgery

Time Frame

Surgical Procedure

Other Pre-specified Outcome Measures:

Title

Changes in blood glucose in mg/dl

Description

For the Mixed Meal Tolerance Test

Time Frame

Through Study Completion, up to about 8 weeks

Title

Changes in blood pressure in mmHg

Description

At the Mixed Meal Tolerance Test

Time Frame

Through Study Completion, up to about 8 weeks

Title

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

Description

At the Mixed Meal tolerance Test

Time Frame

Through Study Completion, up to about 8 weeks

Title

Concentration of adiponectin in pg/mg

Description

From adipose biopsy

Time Frame

Surgical Procedure

Title

Concentration of leptin in pg/mg

Description

From adipose biopsy

Time Frame

Surgical Procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven K Malin

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26627222

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.

Results Reference

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PubMed Identifier

25132119

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.

Results Reference

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PubMed Identifier

23196991

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.

Results Reference

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PubMed Identifier

25437877

Citation

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.

Results Reference

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PubMed Identifier

25651277

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.

Results Reference

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PubMed Identifier

23529939

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.

Results Reference

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PubMed Identifier

23036993

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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PubMed Identifier

24064339

Citation

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.

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Citation

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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.

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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.

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

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