Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Copeptin and Nonalcoholic Fatty Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03254563
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. The investigators intend to investigate if there is an association of vasopressin with the presence and severity of NAFLD.

Condition or disease
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Copeptin and Nonalcoholic Fatty Liver Disease
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Obese with NAFLD
Patients who have NAFLD based upon ultrasound
Obese without NAFLD
Patients who do not have NAFLD based upon ultrasound


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. Copeptin and level of steatosis [ Time Frame: Within one week of fibroscan being perfomed ]
    Comparison of CAP score of fibroscan to copeptin levels

  3. Copeptin and Liver Elastography [ Time Frame: Within one week of fibroscan being perfomed ]
    Compare Copeptin to liver elastography (kPa)


Secondary Outcome Measures :
  1. Insulin Resistance and copeptin [ Time Frame: Same day as these labs after 8 hour fast from food and water. ]
    Changes in insulin, fasting glucose, HOMA-IR, HOMA-B, adiponectin estimated Insulin Compared to copeptin level

  2. Copeptin and Lipids [ Time Frame: Same day as these labs after 8 hour fast from food and water. ]
    Compare copeptin level to cholesterol and free fatty acids

  3. Copeptin and Liver enzymes [ Time Frame: Same day as these labs after 8 hour fast from food and water. ]
    Compare copeptin and liver enzymes

  4. Copeptin and Weight [ Time Frame: Within 1 month of screening visit ]
    Compare Copeptin with BMI

  5. Copeptin and Waist Circumference [ Time Frame: Within 1 month of screening visit ]
    Compare copeptin with weight circumference

  6. Copeptin and Blood pressure [ Time Frame: Within 1 month of screening visit ]
    Compare copetin with measurements of blood pressure


Biospecimen Retention:   Samples Without DNA
Serum and urine

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

  1. Patients age 30-75
  2. BMI 30-40
  3. Presence of fatty liver on ultrasound

Exclusion Criteria:

  1. Diabetes mellitus (determined by prior HbA1c, fasting glucose, and/or random glucose in the last three months according to ADA criteria),
  2. Medication known to affect insulin sensitivity e.g. metformin, thiazolidinediones, systemic steroids, atypical antipsychotics),
  3. Fibrates,
  4. eGFR <45 ml/min/1.73m2 by MDRD equation(11),
  5. Pregnancy,
  6. Breast feeding,
  7. Sodium <135 mEq/L,
  8. Diabetes insipidus,
  9. Liver disease other than NAFLD (including obstructive liver disease),
  10. ALT or AST>60 IU/L,
  11. Hepatic steatosis on ultrasound for the non-NAFLD group,
  12. Congestive heart failure,
  13. Patients who consume >20g of ETOH a day,
  14. Patients found to have Cushing's disease based upon 24 hour urine results (Urine Free cortisol >2x upper limit of normal).
  15. Patient's with pacemakers
  16. Off of Coenzyme Q for 6 months.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254563


Contacts
Layout table for location contacts
Contact: Thomas Jensen, MD 7208482650 thomas.jensen@ucdenver.edu
Contact: Kristen Nadeau, MD (720) 777-6128 Kristen.Nadeau@childrenscolorado.org

Locations
Layout table for location information
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Thomas Jensen, MD    720-848-2650      
Contact: Kristen Nadeau, MD    720-777-2855    Kristen.Nadeau@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Thomas Jensen, MD University of Colorado, Denver
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03254563    
Other Study ID Numbers: 17-1160
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases