Status:
UNKNOWN
Pre-operative Exercise and Nutrition Therapy on Cardio-metabolic Health in Patients Undergoing Bariatric Surgery
Lead Sponsor:
University of Virginia
Conditions:
Bariatric Surgery Candidate
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 11 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03854981
Start Date
August 11 2015
End Date
May 1 2020
Last Update
February 26 2019
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