Utilization of Very Low Calorie Diet in Obese General Surgery Patients
Completed · Not applicable
Conditions studied: Morbid Obesity
In brief
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.
Key facts
- Study ID
- NCT03553849
- Run by
- Christiana Care Health Services
- People needed
- 58
- Starts
- 2018-09-24
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2021-01-28
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- Christiana Care Health System — Newark, Delaware, United States
Full record on ClinicalTrials.gov
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