Morbid ObesityNCT03553849
Utilization of Very Low Calorie Diet in Obese General Surgery Patients
A study testing Very low calorie diet in people with Morbid Obesity, run by Christiana Care Health Services at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Very low calorie diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health System
Newark, Delaware, 19713
About this study
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.
Read the detailed description
The investigators' objective for this project is to determine the impact of a preoperative VLCD on outcomes for patients undergoing elective general surgery. Included are patients who are obese, BMI >30, and scheduled by a Christiana Care-employed general surgeon for elective general surgery. Eligible patients are those scheduled for elective cholecystectomy, ventral or incisional hernia, umbilical hernia, and inguinal hernia surgery.
The investigators will also be determining the feasibility of introducing a preoperative VLCD for patients undergoing elective general surgery in a Community Hospital setting.
- Conditions
- Morbid Obesity
- Being tested
- Very low calorie diet
- Keywords
- Very low calorie diet, General surgery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low calorie dietDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Very low calorie diet |
| Standard Preop Diet | No intervention | The control group will continue a regular diet until the day before surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Post Operative Complications
Pulmonary, cardiac and surgical complications using data collected from inpatient and outpatient charting
Measured: 30-days post operatively
Secondary outcomes (7)
Feasibility of the Study
Patient satisfaction and compliance based on patient surveys administered prior to discharge from the hospital
Measured: 2 weeks
Effect on Perioperative BMI
Difference in pre operative and perioperative BMI, in kg/m^2
Measured: 2 weeks
Effect on blood glucose levels
Difference in pre operative and perioperative blood glucose levels
Measured: 2 weeks
Effect on insulin administration
Difference in pre operative and perioperative insulin administration, in units
Measured: 2 weeks
Effect on operative times
Comparative operative times, in minutes, between control and intervention
Measured: Day of surgery
Effect on operative blood loss
Comparative operative blood loss, in milliliters, between control and intervention
Measured: Day of surgery
Effect on surgeon perceived difficulty
Comparative surgeon perceived difficulty between control and intervention utilizing a surgeon and procedure specific survey
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start24 Sep 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caitlin A Halbert, DO, MS, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553849
- Sponsor's protocol ID
- DDD603893 / 077069243
- Status last verified
- Jan 2021
- First submitted
- 11 Apr 2018
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Very Low Calorie Diet in Obese General Surgery Patients
- ClinicalTrials.gov ID
- NCT03553849
- Acronym / sponsor ID
- DDD603893 / 077069243
- Conditions
- Morbid Obesity
- Keywords
- Very low calorie diet, General surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators' objective for this project is to determine the impact of a preoperative VLCD on outcomes for patients undergoing elective general surgery. Included are patients who are obese, BMI >30, and scheduled by a Christiana Care-employed general surgeon for elective general surgery. Eligible patients are those scheduled for elective cholecystectomy, ventral or incisional hernia, umbilical hernia, and inguinal hernia surgery.
The investigators will also be determining the feasibility of introducing a preoperative VLCD for patients undergoing elective general surgery in a Community Hospital setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Very Low Calorie Diet | Experimental | Dietary Supplement: Very low calorie dietIf 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. |
| Standard Preop Diet | No intervention | –The control group will continue a regular diet until the day before surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- Patients will be excluded from the study if they have any of the following:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very low calorie dietThe 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. | Dietary supplement | Very Low Calorie Diet |
Primary outcome
Reduction in Post Operative Complications
Time frame: 30-days post operatively
Pulmonary, cardiac and surgical complications using data collected from inpatient and outpatient charting
7 secondary outcomes
Feasibility of the Study
Time frame: 2 weeks
Effect on Perioperative BMI
Time frame: 2 weeks
Effect on blood glucose levels
Time frame: 2 weeks
Effect on insulin administration
Time frame: 2 weeks
Effect on operative times
Time frame: Day of surgery
Effect on operative blood loss
Time frame: Day of surgery
Effect on surgeon perceived difficulty
Time frame: Day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caitlin A Halbert, DO, MS principal investigator
Christiana Care Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very low calorie diet in people with Morbid Obesity, run by Christiana Care Health Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Post Operative Complications (time frame: 30-days post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.