Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT06183034
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 treatment. However, MBS is associated with a higher rate of perioperative morbidity and mortality for patients with Class 4 obesity. Additionally, more patients with Class 4 obesity experience suboptimal weight loss. For patients with Class 4 obesity, preoperative weight loss can reduce the technical difficulty of surgical procedures, rendering MBS safer. Preoperative weight loss may also decrease visceral adipose tissue and liver volume as well as reduce weight-related comorbidities.
A very low-calorie diet (VLCD), which involves restricting caloric intake to approximately 800 kcal/day, is one strategy to help patients achieve weight loss preoperatively. Although studies show that a VLCD prior to MBS yields weight loss, reduces liver volume and rates of perioperative complications, most preoperative VLCDs are short (2-8 weeks) with variable adherence. To date, no study has systematically assessed the feasibility and acceptability of a standard 12-week VLCD among patients with BMI ≥50 pursuing MBS. No study has evaluated postoperative weight loss among patients who have undergone a preoperative VLCD.
This study will be a single arm trial designed to test the feasibility, acceptability, and preliminary efficacy of a 12-week VLCD program prior to sleeve gastrectomy (SG) and associated weight loss up to 1 year following MBS. The investigators will enroll 24 patients aged 18-70, with a BMI≥50Kg/m2, and are approved for SG. Participants will consume up to 5 meal replacement protein shakes and 2 cups of vegetables daily for 12 weeks. Participants will attend weekly in-person office visits with the clinicians at the Hartford Hospital Medical and Surgical Weight Loss Center in Glastonbury, CT to assess weight loss, physical and mental health, feasibility and acceptability of and adherence to the VLCD. The investigators hypothesize that a 12-week VLCD is feasible in this population, defined as ≥70% (18 out of 24 participants) completing the program. The investigators hypothesize that better attendance at the weekly visits and higher adherence to the diet recommendations will provide greater weight loss preoperatively and percent total weight loss at the completion of VLCD, on the day of MBS, and at 3, 6, and 12 months post-surgery. Findings from this study may lead to additional projects that aim to develop and implement an optimal pre-surgery and post-surgery clinical care model for bariatric patients.
Study:
NCT06183034
Study Brief:
Protocol Section:
NCT06183034