Copeptin and Nonalcoholic Fatty Liver Disease

NAFLD Clinical Trial

Official title:

Copeptin and Nonalcoholic Fatty Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03254563
• Other study ID #: 17-1160
• Status: Recruiting
• Start date: June 19, 2018
• Est. completion date: June 2021

Study information

• Verified date: February 2021
• Source: University of Colorado, Denver
• Contact: Thomas Jensen, MD
• Phone: 7208482650
• Email: thomas.jensen[@]ucdenver.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The investigators intend to investigate if there is an association of vasopressin with the presence and severity of NAFLD.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparision of Copeptin with and without NAFLD	The investigators will compare level of copeptin with the measurement of NAFLD based upon ultrasound and fibroscan.	Within 6 months of documented NAFLD or non-NAFLD and within 1 week of fibroscan
Primary	Copeptin and level of steatosis	Comparison of CAP score of fibroscan to copeptin levels	Within one week of fibroscan being perfomed
Primary	Copeptin and Liver Elastography	Compare Copeptin to liver elastography (kPa)	Within one week of fibroscan being perfomed
Secondary	Insulin Resistance and copeptin	Changes in insulin, fasting glucose, HOMA-IR, HOMA-B, adiponectin estimated Insulin Compared to copeptin level	Same day as these labs after 8 hour fast from food and water.
Secondary	Copeptin and Lipids	Compare copeptin level to cholesterol and free fatty acids	Same day as these labs after 8 hour fast from food and water.
Secondary	Copeptin and Liver enzymes	Compare copeptin and liver enzymes	Same day as these labs after 8 hour fast from food and water.
Secondary	Copeptin and Weight	Compare Copeptin with BMI	Within 1 month of screening visit
Secondary	Copeptin and Waist Circumference	Compare copeptin with weight circumference	Within 1 month of screening visit
Secondary	Copeptin and Blood pressure	Compare copetin with measurements of blood pressure	Within 1 month of screening visit