Status:
UNKNOWN
Acceptability and Feasibility of a Preoperative Very Low Calorie Diet Intervention on Surgical Weight Loss Outcomes (SAFETY)
Lead Sponsor:
Hartford Hospital
Conditions:
Obesity
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Class 4 obesity is defined as a BMI ≥50Kg/m2, representing approximately ≥150 pounds of excess weight. For patients with Class 4 obesity, metabolic and bariatric surgery (MBS) is the only effective tr...
Eligibility Criteria
Inclusion
- BMI greater than or equal to 50 kg/m2
- Eligible and approved for sleeve gastrectomy as primary bariatric treatment (eligibility and approval for sleeve gastrectomy will be determined from a surgical standpoint by the surgeon)
- Able and willing to sign an Informed Consent document
Exclusion
- Qualified for Roux-en-Y gastric bypass
- On FDA-approved weight loss medications at time of consult
- Are lactose intolerant
- History of Type 1 diabetes
- Have had lap band or other prior bariatric surgery
- Global functioning score (GFR) ≤45 mL/min/1.73 m² (this is assessed as a part of the routine procedure for all patients)
- \>70 years old (our program does surgery on very few patients over this age)
- Weight is above 300 kgs (\~660 lbs.). (The weight limit for SECA scales is 300 kgs maximum).
- Have been diagnosed with end stage renal disease (CKD stage 3-5) and on dialysis
- Severe depression measured by Beck Depression Inventory (BDI) (BDI score greater than or equal to 30)
- History of severe psychiatric disorder (schizophrenia, schizoaffective, or bipolar disorder)
Key Trial Info
Start Date :
March 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06183034
Start Date
March 5 2024
End Date
December 30 2025
Last Update
February 28 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hartford Hospital
Hartford, Connecticut, United States, 06102