Acceptability and Feasibility of a Preoperative Very Low Calorie Diet Intervention on Surgical Weight Loss Outcomes (SAFETY)

Launched by HARTFORD HOSPITAL · Dec 13, 2023

Keywords

ClinConnect Summary

The SAFETY trial is researching whether a 12-week very low-calorie diet (VLCD) can help individuals with severe obesity (specifically those with a Body Mass Index of 50 or higher) lose weight before undergoing a type of weight loss surgery called sleeve gastrectomy. This diet involves consuming meal replacement protein shakes and vegetables, which aims to make the surgery safer and improve weight loss results afterward. The study will enroll 24 participants aged 18 to 70 who qualify for the surgery and are willing to follow the diet and attend weekly check-ins at Hartford Hospital in Connecticut.

To be eligible, participants need to have a BMI of 50 or more and be approved for sleeve gastrectomy. However, those with certain health conditions, previous weight loss surgeries, or severe psychiatric disorders will not be included. Throughout the trial, participants can expect to follow the VLCD under the guidance of medical professionals, monitor their weight loss, and assess how well they stick to the diet. The goal is to see if this extended diet program is practical and beneficial, potentially leading to better surgical outcomes and improved care for future bariatric patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)