NCT03254563

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

June 19, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

August 16, 2017

Last Update Submit

February 9, 2021

Conditions

NAFLD

Outcome Measures

Primary Outcomes (3)

  • 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

  • Copeptin and level of steatosis

    Comparison of CAP score of fibroscan to copeptin levels

    Within one week of fibroscan being perfomed

  • Copeptin and Liver Elastography

    Compare Copeptin to liver elastography (kPa)

    Within one week of fibroscan being perfomed

Secondary Outcomes (6)

  • Insulin Resistance and copeptin

    Same day as these labs after 8 hour fast from food and water.

  • Copeptin and Lipids

    Same day as these labs after 8 hour fast from food and water.

  • Copeptin and Liver enzymes

    Same day as these labs after 8 hour fast from food and water.

  • Copeptin and Weight

    Within 1 month of screening visit

  • Copeptin and Waist Circumference

    Within 1 month of screening visit

  • +1 more secondary outcomes

Study Arms (2)

Obese with NAFLD

Patients who have NAFLD based upon ultrasound

Obese without NAFLD

Patients who do not have NAFLD based upon ultrasound

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Patients age 30-75
  • BMI 30-40
  • Presence of fatty liver on ultrasound

You may not qualify if:

  • 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,
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Thomas Jensen, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Jensen, MD

CONTACT

7208482650thomas.jensen@ucdenver.edu

Kristen Nadeau, MD

CONTACT

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

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2017

First Posted

August 18, 2017

Study Start

June 19, 2018

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)