Utilization of Very Low Calorie Diet in Obese General Surgery Patients

NCT03553849 | Completed

• 1 other identifier: DDD603893 / 077069243
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are studying the use of a two-week very low calorie diet (VLCD) in obese general surgery patients in a randomized single-blinded trial. The investigators hypothesize that the VLCD will positively impact the perceived surgical difficulty, operative time, hospital length of stay and 30-day complications. Additionally, the investigators anticipate reduced perioperative blood glucose levels and a reduced need for perioperative insulin administration.

Conditions

Morbid Obesity

Keywords

Very low calorie diet; General surgery

Outcome Measures

Primary Outcomes (1)

• Reduction in Post Operative Complications

  Pulmonary, cardiac and surgical complications using data collected from inpatient and outpatient charting

  30-days post operatively

Secondary Outcomes (7)

• Feasibility of the Study

  2 weeks

• Effect on Perioperative BMI

  2 weeks

• Effect on blood glucose levels

  2 weeks

• Effect on insulin administration

  2 weeks

• Effect on operative times

  Day of surgery

Study Arms (2)

Very Low Calorie Diet

EXPERIMENTAL

If they are randomized into the treatment arm, they will be prescribed with a 2-week VLCD that will begin 2 weeks prior to the scheduled elective surgery. Patients will be required to pay for the meal replacements.

Dietary Supplement: Very low calorie diet

Standard Preop Diet

NO INTERVENTION

The control group will continue a regular diet until the day before surgery.

Interventions

Very low calorie diet DIETARY_SUPPLEMENT

The VLCD is a prescribed diet with well-balanced macro and micronutrients. It is intended for significant weight loss in a short period of time, is intended only for the extremely obese, and must be completed under the supervision of a trained physician.

Very Low Calorie Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are obese, BMI \>30, and scheduled by a Christiana Care-employed general surgeon for elective general surgery.
• Patients between the ages of 18 and 65.
• Patients scheduled for elective cholecystectomy, ventral or incisional hernia, umbilical hernia, and inguinal hernia surgery.

You may not qualify if:

• Patients will be excluded from the study if they have any of the following:
• Recent myocardial infarction (3-6 months).
• History of cerebral vascular accident (stroke).
• Diabetes mellitus with a history of severe ketoacidosis.
• Patients on SGLT2 inhibitors (glifozins) without insulin
• Chronic use of steroids, greater than 20mg daily.
• Bleeding peptic ulcer (unless there is radiological evidence of healing 6 months prior to entry).
• A psychiatric history that includes suicide attempts and anyone taking psychotropic drugs, including lithium carbonate.
• Active thrombophlebitis (or any other condition where decreased blood volume would put the patient at risk).
• In addition, patients who are pregnant are excluded. If status is unknown, a pregnancy test will be required prior to the start of the VLCD.

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care Health System

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Caitlin A Halbert, DO, MS

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The operative surgeons will be blinded to the randomization. The patient, by nature of the study, will not be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patient will be randomized into the treatment or control arm by the research team. If they are randomized into the treatment arm, they will be prescribed with a 2-week VLCD that will begin 2 weeks prior to the scheduled elective surgery.

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: June 12, 2018
• Study Start: September 24, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)