Nonalcoholic Fatty Liver DiseaseNCT01645852
A Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection
A study testing Optifast 800 in people with Nonalcoholic Fatty Liver Disease and Hepatic Steatosis, run by Dartmouth-Hitchcock Medical Center at 3 sites in United States.
Trial summary
The purpose of this study is to measure the effect of a short-term low calorie diet on patients with a Body Mass Index (BMI) over 25 who are undergoing liver surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease, Hepatic Steatosis, Steatohepatitis
- What is being tested?
- Optifast 800
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2012to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or greater
- Clinical indication for a therapeutic liver resection
- BMI of 25 kg/m2 or greater
- Informed Consent
Who cannot join
- Inability to comply with the pre-op diet
- Patients who have lost 5% or more of their usual body weight over the preceding one month
- Female patients of childbearing age who have a positive pregnancy test
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Fletcher Allen Health Care
Burlington, Vermont, 05401
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: A Randomized Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection
The purpose of this study is to measure the effect of a short-term low calorie diet on patients with a Body Mass Index (BMI) over 25 who are undergoing liver surgery.
- Being tested
- Optifast 800
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optifast 800Dietary supplement
Five units of Optifast 800 plus an unlimited volume of calorie-free fluids per day for one week prior to hepatic resection.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No specified diet for one week prior to hepatic resection. |
| Low calorie diet | Active comparator | Low calorie diet (five units of Optifast 800 {Nestle Nutrition, Vevey, Switzerland} plus an unlimited volume of calorie free fluids per day) for one week prior to hepatic resection. Receives: Dietary Supplement: Optifast 800 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of a low calorie diet on intra-operative blood loss, technical ease of hepatic transection, complication rates (including infectious complications), length of stay and mortality in patients undergoing liver surgery.
Intra-operative blood loss will be strictly quantified. Units of autologous or donor blood transfused will be recorded. The surgeon will assess the ease of liver mobilization and parenchymal transection using a 1-5 scale where 1 is easy and 5 is hard. Post-operative complications, length of stay and mortality will be recorded.
Measured: 30 days post-operatively
Secondary outcomes (2)
The effect of a low calorie diet on steatosis and steatohepatitis.
Using tissue from hepatic parenchyma adjacent to resected neoplasms steatosis and steatohepatitis will be evaluated by a pathologist blinded to dietary intervention. Steatosis will be defined as mild, moderate or severe if 5-33%, 34-66%, or >66% of hepatocytes contain fat inclusions. Steatohepatitis will be defined using NAFLD (Non-Alcoholic Fatty Liver Disease) Activity Score (NAS) as an NAS 4 or greater, with <4 defined as no steatohepatitis.
Measured: 30 days post-operatively
The mechanism of decreased steatosis in patients undergoing a low-calorie pre-op diet by measuring levels of expression of molecules involved in the de novo synthesis, hepatic uptake and degradation of lipids.
Levels of expression of molecules involved in the de novo synthesis, hepatic uptake and degradation of lipids will be measured to evaluate the mechanism of decreased steatosis.
Measured: 30 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard J. Barth, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645852
- Sponsor's protocol ID
- DMS 12052
- Status last verified
- Feb 2017
- First submitted
- 17 Jul 2012
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection
- ClinicalTrials.gov ID
- NCT01645852
- Acronym / sponsor ID
- DMS 12052
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Jul 2012 (estimated)
- 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 purpose of this study is to measure the effect of a short-term low calorie diet on patients with a Body Mass Index (BMI) over 25 who are undergoing liver surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No specified diet for one week prior to hepatic resection. |
| Low calorie diet | Active comparator | Dietary Supplement: Optifast 800Low calorie diet (five units of Optifast 800 {Nestle Nutrition, Vevey, Switzerland} plus an unlimited volume of calorie free fluids per day) for one week prior to hepatic resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or greater
- Clinical indication for a therapeutic liver resection
- BMI of 25 kg/m2 or greater
- Informed Consent
Key exclusion criteria (3 listed)
- Inability to comply with the pre-op diet
- Patients who have lost 5% or more of their usual body weight over the preceding one month
- Female patients of childbearing age who have a positive pregnancy test
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 |
|---|---|---|
| Optifast 800Five units of Optifast 800 plus an unlimited volume of calorie-free fluids per day for one week prior to hepatic resection. | Dietary supplement | Low calorie diet |
Primary outcome
The effect of a low calorie diet on intra-operative blood loss, technical ease of hepatic transection, complication rates (including infectious complications), length of stay and mortality in patients undergoing liver surgery.
Time frame: 30 days post-operatively
Intra-operative blood loss will be strictly quantified. Units of autologous or donor blood transfused will be recorded. The surgeon will assess the ease of liver mobilization and parenchymal transection using a 1-5 scale where 1 is easy and 5 is hard. Post-operative complications, length of stay and mortality will be recorded.
2 secondary outcomes
The effect of a low calorie diet on steatosis and steatohepatitis.
Time frame: 30 days post-operatively
The mechanism of decreased steatosis in patients undergoing a low-calorie pre-op diet by measuring levels of expression of molecules involved in the de novo synthesis, hepatic uptake and degradation of lipids.
Time frame: 30 days post-operatively
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 8 Feb 2017.
Related trials for Nonalcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
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.
Richard J. Barth, MD principal investigator
Dartmouth-Hitchcock Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optifast 800 in people with Nonalcoholic Fatty Liver Disease and Hepatic Steatosis, run by Dartmouth-Hitchcock Medical Center at 3 sites 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 4 inclusion and 3 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 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The effect of a low calorie diet on intra-operative blood loss, technical ease of hepatic transection, complication rates (including infectious complications), length of stay and mortality in patients undergoing liver surgery. (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 8 Feb 2017.