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临床试验/NCT03254563
NCT03254563Unknown不适用

Copeptin and Nonalcoholic Fatty Liver Disease

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年6月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Comparision of Copeptin with and without NAFLD

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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),
  • eGFR <45 ml/min/1.73m2 by MDRD equation(11),
  • 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
  • Off of Coenzyme Q for 6 months.

结局指标

主要结局

Comparision of Copeptin with and without NAFLD

时间窗: 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

时间窗: Within one week of fibroscan being perfomed

Comparison of CAP score of fibroscan to copeptin levels

Copeptin and Liver Elastography

时间窗: Within one week of fibroscan being perfomed

Compare Copeptin to liver elastography (kPa)

次要结局

  • Copeptin and Liver enzymes(Same day as these labs after 8 hour fast from food and water.)
  • 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 Waist Circumference(Within 1 month of screening visit)
  • Copeptin and Weight(Within 1 month of screening visit)
  • Copeptin and Blood pressure(Within 1 month of screening visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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