NAFLDNCT03254563
Copeptin and Nonalcoholic Fatty Liver Disease
An observational study of NAFLD, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Copeptin, a surrogate marker for vasopressin, has been found to be elevated in metabolic disorders including obesity and diabetes, which are disorders both associated with nonalcoholic fatty liver disease (NAFLD), and therefore suggest a potential role for vasopressin in the pathogenesis of NAFLD. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- NAFLD
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2018to Jun 2021
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Obese adults (BMI 30-40 kg/m2) age 30-75 years with NAFLD based upon ultrasound echogenicity within 6 months of enrollment 2. Obese adults (BMI 30-40 kg/m2) age 30-75 years without NAFLD based upon ultrasound echogenicity within 6 months of enrollment
Who may be able to join
- Patients age 30-75
- BMI 30-40
- Presence of fatty liver on ultrasound
Who cannot join
- Diabetes mellitus (determined by prior HbA1c, fasting glucose, and/or random glucose in the last three months according to ADA criteria),
- Medication known to affect insulin sensitivity e.g. metformin, thiazolidinediones, systemic steroids, atypical antipsychotics),
- Fibrates,
- eGFR <45 ml/min/1.73m2 by MDRD equation(11),
- Pregnancy,
- Breast feeding,
Show all 16Show fewer
- Sodium <135 mEq/L,
- Diabetes insipidus,
- Liver disease other than NAFLD (including obstructive liver disease),
- ALT or AST>60 IU/L,
- Hepatic steatosis on ultrasound for the non-NAFLD group,
- Congestive heart failure,
- Patients who consume >20g of ETOH a day,
- Patients found to have Cushing's disease based upon 24 hour urine results (Urine Free cortisol >2x upper limit of normal).
- Patient's with pacemakers
- Off of Coenzyme Q for 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Thomas Jensen, MD, 720-848-2650
Kristen Nadeau, MD, 720-777-2855, Kristen.Nadeau@childrenscolorado.org
About this study
Copeptin, a surrogate marker for vasopressin, has been found to be elevated in metabolic disorders including obesity and diabetes, which are disorders both associated with nonalcoholic fatty liver disease (NAFLD), and therefore suggest a potential role for vasopressin in the pathogenesis of NAFLD. The investigators intend to investigate if there is an association of vasopressin with the presence and severity of NAFLD.
Read the detailed description
Participants: As a pilot study, the investigators will recruit 30 obese adults with NAFLD based upon ultrasound echogenicity within 6 months of enrollment, and 30 obese adults without NAFLD based upon ultrasound (US) echogenicity for comparison.
Screening Visit/Study Visit: Patients in the investigator's Obesity clinic will be approached about the study and consented if interested at the screening. Participants will have a chart review for their history and physical Exam and medication review for inclusion and exclusion criteria. Qualified participants will be invited for a screening visit to be scheduled in conjunction with the labs and procedures performed as Standard of Care (SOC) in the obesity clinic. At the screening visit, following consent, participants will have vitals (blood pressure, Body Mass Index (BMI), waist circumference) and a physical examination performed. Participants' Standard of Care (SOC) labs including fasting lipid panel, HbA1c (unless done within last 3 months), comprehensive metabolic panel, titers for hepatitis b and c, and complete blood count will be drawn, along with the following research labs: insulin, glucagon, free fatty acids, adiponectin and a 24-hour urine cortisol collection. Those who have not had an abdominal US will have a SOC US performed to delineate non-NAFLD or NAFLD status. US will not be performed if already done within 6 months of enrollment. All ultrasound studies will be interpreted by one University of Colorado Denver radiologist to categorize the patient as NAFLD or non-NAFLD to limit inter-reader variability. Those with NAFLD present on US will also have a SOC Fibroscan done to assess severity of steatosis (based upon Controlled Attenuation Parameter or CAP Score) and fibrosis (based upon elastography). Given limitations of ultrasound to accurately detect significant steatosis unless >30%, the investigators will in addition perform Fibroscan (all particpants regardless of US) to assess steatosis, so as to confirm if significant steatosis and compare copeptin levels on a continuum of level of steatosis as part of research procedure. Fibroscan can detect steatosis (based upon Controlled Attenuation Parameter or CAP Score) and fibrosis (based upon elastography). FIbroscan with M probe has been found to have AUROC 0.823 for a cutoff of value of 248 dB/m for no steatosis vs steatosis (with other cutoffs at 268 dB/m between S1 and S2-S3 and 280 dB/m between S1-S2 and S3 disease).
- Conditions
- NAFLD
- 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 |
|---|---|---|
| Obese with NAFLD | Patients who have NAFLD based upon ultrasound | |
| Obese without NAFLD | Patients who do not have NAFLD based upon ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparision of Copeptin with and without NAFLD
The investigators will compare level of copeptin with the measurement of NAFLD based upon ultrasound and fibroscan.
Measured: Within 6 months of documented NAFLD or non-NAFLD and within 1 week of fibroscan
Copeptin and level of steatosis
Comparison of CAP score of fibroscan to copeptin levels
Measured: Within one week of fibroscan being perfomed
Copeptin and Liver Elastography
Compare Copeptin to liver elastography (kPa)
Measured: Within one week of fibroscan being perfomed
Secondary outcomes (6)
Insulin Resistance and copeptin
Changes in insulin, fasting glucose, HOMA-IR, HOMA-B, adiponectin estimated Insulin Compared to copeptin level
Measured: Same day as these labs after 8 hour fast from food and water.
Copeptin and Lipids
Compare copeptin level to cholesterol and free fatty acids
Measured: Same day as these labs after 8 hour fast from food and water.
Copeptin and Liver enzymes
Compare copeptin and liver enzymes
Measured: Same day as these labs after 8 hour fast from food and water.
Copeptin and Weight
Compare Copeptin with BMI
Measured: Within 1 month of screening visit
Copeptin and Waist Circumference
Compare copeptin with weight circumference
Measured: Within 1 month of screening visit
Copeptin and Blood pressure
Compare copetin with measurements of blood pressure
Measured: Within 1 month of screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start19 Jun 2018
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Jensen, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254563
- Sponsor's protocol ID
- 17-1160
- Status last verified
- Feb 2021
- First submitted
- 16 Aug 2017
- Last updated
- 10 Feb 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 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin and Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03254563
- Acronym / sponsor ID
- 17-1160
- Conditions
- NAFLD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 18 Aug 2017 (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.
Copeptin, a surrogate marker for vasopressin, has been found to be elevated in metabolic disorders including obesity and diabetes, which are disorders both associated with nonalcoholic fatty liver disease (NAFLD), and therefore suggest a potential role for vasopressin in the pathogenesis of NAFLD. The investigators intend to investigate if there is an association of vasopressin with the presence and severity of NAFLD.
Detailed description
Participants: As a pilot study, the investigators will recruit 30 obese adults with NAFLD based upon ultrasound echogenicity within 6 months of enrollment, and 30 obese adults without NAFLD based upon ultrasound (US) echogenicity for comparison.
Screening Visit/Study Visit: Patients in the investigator's Obesity clinic will be approached about the study and consented if interested at the screening. Participants will have a chart review for their history and physical Exam and medication review for inclusion and exclusion criteria. Qualified participants will be invited for a screening visit to be scheduled in conjunction with the labs and procedures performed as Standard of Care (SOC) in the obesity clinic. At the screening visit, following consent, participants will have vitals (blood pressure, Body Mass Index (BMI), waist circumference) and a physical examination performed. Participants' Standard of Care (SOC) labs including fasting lipid panel, HbA1c (unless done within last 3 months), comprehensive metabolic panel, titers for hepatitis b and c, and complete blood count will be drawn, along with the following research labs: insulin, glucagon, free fatty acids, adiponectin and a 24-hour urine cortisol collection. Those who have not had an abdominal US will have a SOC US performed to delineate non-NAFLD or NAFLD status. US will not be performed if already done within 6 months of enrollment. All ultrasound studies will be interpreted by one University of Colorado Denver radiologist to categorize the patient as NAFLD or non-NAFLD to limit inter-reader variability. Those with NAFLD present on US will also have a SOC Fibroscan done to assess severity of steatosis (based upon Controlled Attenuation Parameter or CAP Score) and fibrosis (based upon elastography). Given limitations of ultrasound to accurately detect significant steatosis unless >30%, the investigators will in addition perform Fibroscan (all particpants regardless of US) to assess steatosis, so as to confirm if significant steatosis and compare copeptin levels on a continuum of level of steatosis as part of research procedure. Fibroscan can detect steatosis (based upon Controlled Attenuation Parameter or CAP Score) and fibrosis (based upon elastography). FIbroscan with M probe has been found to have AUROC 0.823 for a cutoff of value of 248 dB/m for no steatosis vs steatosis (with other cutoffs at 268 dB/m between S1 and S2-S3 and 280 dB/m between S1-S2 and S3 disease).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese with NAFLD | – | –Patients who have NAFLD based upon ultrasound |
| Obese without NAFLD | – | –Patients who do not have NAFLD based upon ultrasound |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Obese adults (BMI 30-40 kg/m2) age 30-75 years with NAFLD based upon ultrasound echogenicity within 6 months of enrollment 2. Obese adults (BMI 30-40 kg/m2) age 30-75 years without NAFLD based upon ultrasound echogenicity within 6 months of enrollment
Key inclusion criteria (3 listed)
- Patients age 30-75
- BMI 30-40
- Presence of fatty liver on ultrasound
Key exclusion criteria (16 listed)
- Diabetes mellitus (determined by prior HbA1c, fasting glucose, and/or random glucose in the last three months according to ADA criteria),
- Medication known to affect insulin sensitivity e.g. metformin, thiazolidinediones, systemic steroids, atypical antipsychotics),
- Fibrates,
- eGFR <45 ml/min/1.73m2 by MDRD equation(11),
- Pregnancy,
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
Comparision of Copeptin with and without NAFLD
Time frame: Within 6 months of documented NAFLD or non-NAFLD and within 1 week of fibroscan
The investigators will compare level of copeptin with the measurement of NAFLD based upon ultrasound and fibroscan.
Copeptin and level of steatosis
Time frame: Within one week of fibroscan being perfomed
Comparison of CAP score of fibroscan to copeptin levels
Copeptin and Liver Elastography
Time frame: Within one week of fibroscan being perfomed
Compare Copeptin to liver elastography (kPa)
6 secondary outcomes
Insulin Resistance and copeptin
Time frame: Same day as these labs after 8 hour fast from food and water.
Copeptin and Lipids
Time frame: Same day as these labs after 8 hour fast from food and water.
Copeptin and Liver enzymes
Time frame: Same day as these labs after 8 hour fast from food and water.
Copeptin and Weight
Time frame: Within 1 month of screening visit
Copeptin and Waist Circumference
Time frame: Within 1 month of screening visit
Copeptin and Blood pressure
Time frame: Within 1 month of screening visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 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.
Thomas Jensen, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD, run by University of Colorado, Denver 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 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 10 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Jensen, MD (7208482650, thomas.jensen@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparision of Copeptin with and without NAFLD (time frame: Within 6 months of documented NAFLD or non-NAFLD and within 1 week of fibroscan). The study lists 3 primary outcomes in all. 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 10 Feb 2021.