Weight GainNCT04145427
Impact of a LCD on Metabolic Inflexibility and Cardiovascular Risk in Liver Transplant Patients
A study testing LCD in people with Weight Gain, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study is looking to see how a 6-month low carbohydrate diet can affect the body's ability to use energy in addition to the affects it has on the heart and blood vessel health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Gain
- What is being tested?
- LCD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2020to 15 Sep 2023
- 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 years
- At least 12 months after LT
- Obese (BMI > 30kg/m2)
Who cannot join
- Acute cellular or chronic rejection within 3 months
- Post-LT liver or non-liver related malignancy
- Active viral hepatitis (B or C), autoimmune hepatitis
- Untreated biliary strictures or vascular complications (i.e. hepatic artery thrombosis)
- Poorly controlled Diabetes mellitus
- Relapse of alcohol abuse after LT
- Stage 5 Chronic Kidney Disease
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Impact of a Low Carbohydrate Diet (LCD) on Metabolic Inflexibility and Cardiovascular Risk in Liver Transplant (LT) Patients
This study is looking to see how a 6-month low carbohydrate diet can affect the body's ability to use energy in addition to the affects it has on the heart and blood vessel health.
Read the detailed description
Weight gain often occurs following a liver transplant. This weight gain is problematic as it leads to many other health problems. The reasons of this weight gain are still poorly understood. To better understand weight gain, this study is looking to see how a 6-month low carbohydrate diet can affect the body's ability to use energy in addition to the affects it has on heart and blood vessel health.
This study will help researchers to better understand weight gain after a transplant. This knowledge will help doctors prevent weight gain after a liver transplant and therefore improve the health of liver transplant patients.
- Conditions
- Weight Gain
- Being tested
- Control, LCD
- Keywords
- Liver Transplant, Low Carbohydrate Diet
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
Initial Weight Loss consultation
1.5 hour session on how to do implement healthy diet and then have a 2-week follow-up class. Information on how to maintain a healthy combination protein, fat and vegetables daily will be provided provided.
4 lifestyle coaching sessions
Monthly visits for behavioral and dietary coaching as well as medication management.
LCDBehavioural
Initial Weight Loss consultation
1.5 hour session on how to do implement healthy diet and then have a 2-week follow-up class. Information on how to maintain a LCD will be provided provided.
4 lifestyle coaching sessions
Monthly visits for behavioral and dietary coaching as well as medication management.
| Study group | Role | What they receive |
|---|---|---|
| Low Carbohydrate Diet | Experimental | This arm will be randomized to low carbohydrate diet Receives: Behavioral: LCD |
| Standard Dietary Advice Control Group | Active comparator | This arm will be randomized to control diet Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Weight will be measured on a standardized scale in kilograms that will be zeroed out prior to the measurement
Measured: baseline to 6 months
Secondary outcomes (5)
Change in metabolic flexibility
This will be measured in whole room calorimeter and reported as respiratory quotient
Measured: baseline to 6 months
Change in LDL-C
LDL-cholesterol will be measured using a fasting blood draw and a standard lipid panel.
Measured: baseline to 6 months
Change in total cholesterol
Total cholesterol will be measured using a fasting blood draw and a standard lipid panel.
Measured: baseline to 6 months
Change in small dense low-density lipoprotein
Small dense LDL will be measured using a fasting blood draw and a standard lipid panel.
Measured: baseline to 6 months
Change in adiposity
This will be measured on body composition MRI where subcutaneous and visceral fat will be quantified. Subcutaneous fat and visceral fat volume will measured on body composition MRI in liters (L) and standardized to body height and will be reported as liter/m2
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start27 Feb 2020
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Siddiqui, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145427
- Sponsor's protocol ID
- HM20017667
- Status last verified
- Aug 2024
- First submitted
- 28 Oct 2019
- Last updated
- 20 Aug 2024
- Results posted
- 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 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Low Carbohydrate Diet (LCD) on Metabolic Inflexibility and Cardiovascular Risk in Liver Transplant (LT) Patients
- ClinicalTrials.gov ID
- NCT04145427
- Acronym / sponsor ID
- HM20017667
- Conditions
- Weight Gain
- Keywords
- Liver Transplant, Low Carbohydrate Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 30 Oct 2019 (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.
This study is looking to see how a 6-month low carbohydrate diet can affect the body's ability to use energy in addition to the affects it has on the heart and blood vessel health.
Detailed description
Weight gain often occurs following a liver transplant. This weight gain is problematic as it leads to many other health problems. The reasons of this weight gain are still poorly understood. To better understand weight gain, this study is looking to see how a 6-month low carbohydrate diet can affect the body's ability to use energy in addition to the affects it has on heart and blood vessel health.
This study will help researchers to better understand weight gain after a transplant. This knowledge will help doctors prevent weight gain after a liver transplant and therefore improve the health of liver transplant patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Carbohydrate Diet | Experimental | Behavioral: LCDThis arm will be randomized to low carbohydrate diet |
| Standard Dietary Advice Control Group | Active comparator | Behavioral: ControlThis arm will be randomized to control diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- At least 12 months after LT
- Obese (BMI > 30kg/m2)
Key exclusion criteria (8 listed)
- Acute cellular or chronic rejection within 3 months
- Post-LT liver or non-liver related malignancy
- Active viral hepatitis (B or C), autoimmune hepatitis
- Untreated biliary strictures or vascular complications (i.e. hepatic artery thrombosis)
- Poorly controlled Diabetes mellitus
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 |
|---|---|---|
| ControlInitial Weight Loss consultation 1.5 hour session on how to do implement healthy diet and then have a 2-week follow-up class. Information on how to maintain a healthy combination protein, fat and vegetables daily will be provided provided. 4 lifestyle coaching sessions Monthly visits for behavioral and dietary coaching as well as medication management. | Behavioural | Standard Dietary Advice Control Group |
| LCDInitial Weight Loss consultation 1.5 hour session on how to do implement healthy diet and then have a 2-week follow-up class. Information on how to maintain a LCD will be provided provided. 4 lifestyle coaching sessions Monthly visits for behavioral and dietary coaching as well as medication management. | Behavioural | Low Carbohydrate Diet |
Primary outcome
Change in weight
Time frame: baseline to 6 months
Weight will be measured on a standardized scale in kilograms that will be zeroed out prior to the measurement
5 secondary outcomes
Change in metabolic flexibility
Time frame: baseline to 6 months
Change in LDL-C
Time frame: baseline to 6 months
Change in total cholesterol
Time frame: baseline to 6 months
Change in small dense low-density lipoprotein
Time frame: baseline to 6 months
Change in adiposity
Time frame: baseline to 6 months
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 20 Aug 2024.
- 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.
Mohammad Siddiqui, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCD in people with Weight Gain, run by Virginia Commonwealth University 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 8 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 20 Aug 2024. 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?
Change in weight (time frame: baseline to 6 months). 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 20 Aug 2024.