Recruiting

Copeptin with Nonalcoholic Fatty Liver Disease

Sponsor:

University of Colorado, Denver

Code:

NCT03254563

Conditions

NAFLD

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

NAFLD

Study ID

NCT03254563

Start date

Jun 19, 2018

Status verified date

Feb, 2021

Completion date

Jun, 2021

Anticipated

Primary completion date

Jun, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Obese with NAFLD

Patients who have NAFLD based upon ultrasound

Obese without NAFLD

Patients who do not have NAFLD based upon ultrasound

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 ]
  • Copeptin and level of steatosis [ Time Frame: Within one week of fibroscan being perfomed ]
  • Copeptin and Liver Elastography [ Time Frame: Within one week of fibroscan being perfomed ]

Central Contacts and Locations

Central contacts

Thomas Jensen, MD

7208482650thomas.jensen@ucdenver.edu

Kristen Nadeau, MD

(720) 777-6128Kristen.Nadeau@childrenscolorado.org

Locations

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Thomas Jensen, MD

720-848-2650

Kristen Nadeau, MD

720-777-2855Kristen.Nadeau@childrenscolorado.org

More Information

Sponsor

University of Colorado, Denver

Last update posted

Feb 10, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2021-02-10.