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Very Low Calorie Diet for Obesity (SAFETY Trial)

N/A
Waitlist Available
Research Sponsored by Hartford Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
On FDA-approved weight loss medications at time of consult
History of Type 1 diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 through 12 of the 12 week vlcd program
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test the feasibility and effectiveness of a 12-week very low-calorie diet (VLCD) program for patients with severe obesity who are undergoing weight loss surgery. The study will enroll

Who is the study for?
This trial is for adults aged 18-70 with Class 4 obesity (BMI ≥50Kg/m2) who are approved for sleeve gastrectomy. It aims to see if a strict diet of about 800 calories per day, using protein shakes and vegetables for 12 weeks before surgery, can make the operation safer and improve weight loss outcomes.
What is being tested?
The study tests a preoperative very low-calorie diet's feasibility and effectiveness in patients with severe obesity undergoing sleeve gastrectomy. Participants will follow this diet strictly for three months, attending weekly check-ups to monitor their progress.
What are the potential side effects?
Potential side effects may include fatigue, nutrient deficiencies, mood changes, or gallstones due to rapid weight loss. Close monitoring during the trial aims to manage any adverse effects promptly.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking FDA-approved weight loss medications.
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I have been diagnosed with Type 1 diabetes.
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I have severe depression, with a BDI score of 30 or more.
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I have severe kidney disease and am on dialysis.
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I have had weight loss surgery in the past.
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I am eligible for Roux-en-Y gastric bypass surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 through 12 of the 12 week vlcd program
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 through 12 of the 12 week vlcd program for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of participants who complete the 12-week VLCD program
Secondary study objectives
VLCD acceptability

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Very Low Calorie DietExperimental Treatment1 Intervention
Very Low Calorie Diet - caloric intake restricted to approximately 800 kcal/day

Find a Location

Who is running the clinical trial?

Hartford HospitalLead Sponsor
138 Previous Clinical Trials
19,367 Total Patients Enrolled
7 Trials studying Obesity
603 Patients Enrolled for Obesity
~17 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
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