Nonalcoholic Fatty Liver DiseaseNCT06166797
Elucidating Growth Hormone Dynamics at Stages of Progressive Nonalcoholic Fatty Liver Disease
An observational study of Nonalcoholic Fatty Liver Disease, run by Massachusetts General Hospital.
Trial summary
The purpose of this study is to investigate relationships between the body's growth hormone "axis" and nonalcoholic fatty liver disease. The growth hormone "axis" includes the hormones growth hormone and insulin-like growth factor 1, and associated proteins. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 31 Jul 2024
- Phase
- Observational
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men 18-70yo with or without nonalcoholic fatty liver disease
Who may be able to join
- Men 18-70yo
- BMI between 25kg/m2 - 40kg/m2.
- Hepatitis C antibody and Hepatitis B surface antigen negative.
- Meet inclusion criteria for one of Groups 1-3 based on medical history, laboratory criteria, and hepatic fat fraction (1H-MRS) and/or liver biopsy
- Group 1: No NAFLD: no history of NAFLD/NASH, hepatic fat fraction <5% on 1H-MRS, ALT < 30 U/L.
- Group 2: Simple Steatosis: no history of NASH, hepatic fat fraction ≥10% on 1H-MRS, ALT < 30 U/L.
- Group 3: Nonalcoholic Steatohepatitis: Biopsy confirmed NASH within the year prior to study participation, with liver fibrosis stage 2 or 3 on biopsy.
Who cannot join
- Heavy alcohol use defined as consumption of > 30mg daily for at least 3 consecutive months over the past 5 years
- Type 1 diabetes, any use of insulin, or any use of other anti-diabetes medication except metformin or sulfonylurea. Individuals with Type 2 diabetes that is controlled by diet or by metformin and/or sulfonylurea will be eligible.
- Use of any specific pharmacological treatments for NAFLD/NASH except vitamin E within the 3 months before screening visit.
- Chronic systemic corticosteroid use in the ≤6 months prior to the baseline visit.
- Chronic use of Actigall, methotrexate, amiodarone, or tamoxifen
- Known diagnosis of alpha-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, or autoimmune hepatitis
Show all 16Show fewer
- Use of GH or GHRH within the past 6 months
- Change in lipid lowering or anti-hypertensive regimen within 2 months of screening
- Hemoglobin < 12.5 g/dL
- Severe chronic illness judged by the investigator to present a contraindication to participation
- History of hypopituitarism, head irradiation or any other condition known to affect the GH axis.
- Use of testosterone or estrogen or progesterone unless physiologic stable testosterone use for at least 1 year prior to study entry
- Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip
- Weight loss surgery within 1 year before baseline. Weight loss surgery more than 1 year prior to baseline visit is permissible if no active weight loss (<10% decrease in weight over past 6 months)
- Lack of fluency in English and/or inability to complete the consent process in English.
- Judge by the investigator to be inappropriate for the study for other reasons not detailed above.
Trial locations and contacts
No sites are listed yet.
Allison Arpante, NP contact
About this study
The purpose of this study is to investigate relationships between the body's growth hormone "axis" and nonalcoholic fatty liver disease. The growth hormone "axis" includes the hormones growth hormone and insulin-like growth factor 1, and associated proteins. We hypothesize that there will be a relationship such that people with more advanced nonalcoholic fatty liver disease will have greater impairments in the growth hormone axis. There are no treatments associated with this research study.
Read the detailed description
Several lines of existing research implicate activity of the GH/IGF-1 axis in the development of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) in humans. Careful phenotyping of GH dynamics in individuals with NAFLD and NASH is required for comprehensive understanding of the degree to which perturbations in the GH axis contribute to the pathogenesis of NAFLD/NASH. The purpose of this research is to comprehensively assess GH dynamics in individuals across the spectrum of NAFLD to determine associations between the GH/IGF-1 axis and stages of disease progression in NAFLD.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No NAFLD | individuals with <5 percent hepatic fat fraction on magnetic resonance spectroscopy | |
| Simple Steatosis | individuals with at least 10% fat fraction on magnetic resonance spectroscopy without any history of nonalcoholic steatohepatitis or evidence of fibrosis | |
| Nonalcoholic Steatohepatitis | individuals with biopsy confirmed nonalcoholic steatohepatitis and stage 2 or 3 fibrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak growth hormone
peak growth hormone level during standard 3-hour glucagon stimulation test
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Dec 2023 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
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 Massachusetts General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takara Stanley, Massachusetts General Hospital
- Investigators
- Steven Grinspoon, MD, Principal investigator, Massachusetts General HospitalTakara Stanley, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166797
- Sponsor's protocol ID
- 2021p-003599
- Status last verified
- Dec 2023
- First submitted
- 17 Nov 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating Growth Hormone Dynamics at Stages of Progressive Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06166797
- Acronym / sponsor ID
- 2021p-003599
- Conditions
- Nonalcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 12 Dec 2023 (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 purpose of this study is to investigate relationships between the body's growth hormone "axis" and nonalcoholic fatty liver disease. The growth hormone "axis" includes the hormones growth hormone and insulin-like growth factor 1, and associated proteins. We hypothesize that there will be a relationship such that people with more advanced nonalcoholic fatty liver disease will have greater impairments in the growth hormone axis. There are no treatments associated with this research study.
Detailed description
Several lines of existing research implicate activity of the GH/IGF-1 axis in the development of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) in humans. Careful phenotyping of GH dynamics in individuals with NAFLD and NASH is required for comprehensive understanding of the degree to which perturbations in the GH axis contribute to the pathogenesis of NAFLD/NASH. The purpose of this research is to comprehensively assess GH dynamics in individuals across the spectrum of NAFLD to determine associations between the GH/IGF-1 axis and stages of disease progression in NAFLD.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No NAFLD | – | –individuals with <5 percent hepatic fat fraction on magnetic resonance spectroscopy |
| Simple Steatosis | – | –individuals with at least 10% fat fraction on magnetic resonance spectroscopy without any history of nonalcoholic steatohepatitis or evidence of fibrosis |
| Nonalcoholic Steatohepatitis | – | –individuals with biopsy confirmed nonalcoholic steatohepatitis and stage 2 or 3 fibrosis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men 18-70yo with or without nonalcoholic fatty liver disease
Key inclusion criteria (7 listed)
- Men 18-70yo
- BMI between 25kg/m2 - 40kg/m2.
- Hepatitis C antibody and Hepatitis B surface antigen negative.
- Meet inclusion criteria for one of Groups 1-3 based on medical history, laboratory criteria, and hepatic fat fraction (1H-MRS) and/or liver biopsy
Key exclusion criteria (16 listed)
- Heavy alcohol use defined as consumption of > 30mg daily for at least 3 consecutive months over the past 5 years
- Type 1 diabetes, any use of insulin, or any use of other anti-diabetes medication except metformin or sulfonylurea. Individuals with Type 2 diabetes that is controlled by diet or by metformin and/or sulfonylurea will be eligible.
- Use of any specific pharmacological treatments for NAFLD/NASH except vitamin E within the 3 months before screening visit.
- Chronic systemic corticosteroid use in the ≤6 months prior to the baseline visit.
- Chronic use of Actigall, methotrexate, amiodarone, or tamoxifen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
peak growth hormone
Time frame: at baseline
peak growth hormone level during standard 3-hour glucagon stimulation test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
Allison Arpante, NP contact
Steven Grinspoon, MD principal investigator
Massachusetts General Hospital
Takara Stanley, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Nonalcoholic Fatty Liver Disease, run by Massachusetts General Hospital.
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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Takara L Stanley, MD (617-724-9109, tstanley@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak growth hormone (time frame: at baseline). 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 12 Dec 2023.