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临床试验/NCT05292352
NCT05292352终止不适用

Prevention of Non-alcoholic Fatty Liver Disease (NAFLD) in Hispanic Children

Emory University1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2022年4月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
103
试验地点
1
主要终点
Change in Percent Hepatic Steatosis by MRI-PDFF

研究概览

简要总结

This is a 2 year clinical trial testing an intensive intervention to reduce dietary sugars as a means to prevent non-alcoholic fatty liver disease (NAFLD) in pre-pubertal Hispanic children.

详细描述

The number of children experiencing obesity and the chronic diseases associated with it has risen dramatically in recent decades. This includes non-alcoholic fatty liver disease (NAFLD). NAFLD is an excess accumulation of fat in the liver that results when children's diet and activity patterns compound the genetic risk they were born with. Excess fat in the liver increases the risk of diabetes and heart disease, as well as the chance that a liver transplant will be needed. Previous studies suggest that diets high in sugar, particularly during critical periods of development, increase children's risk of developing NAFLD. The study team has previously shown that reducing intake of free sugars (those used to sweeten foods and beverages and those found naturally in fruit juices) to very low levels reduce the amount of fat stored in the liver and improves the metabolic health of children with NAFLD.

This single-site randomized clinical trial is designed to determine if following a diet very low in free sugars just before puberty, a time of increased metabolic disruption, can help to prevent NAFLD in children known to be at high risk. This trial will study free-living Hispanic children with overweight or obesity because their increased risk for NAFLD compared to non-Hispanic children has been well documented. Enrollment will include children ages 6-9 years and Tanner stage 1 living in the Atlanta metropolitan area. Recruitment is through local pediatric clinics and through parents attending diabetes and NAFLD clinics. Enrollment and informed consent are performed by members of the research team. The one-year dietary intervention will include a combination of evidence-based strategies: dietary counseling by a nutritionist using motivational interviewing and family-centered goal setting; a one-month provision of a low/free sugar diet for the entire family, and nutritionist-guided (and study-funded) grocery shopping trips every 3 months thereafter. The control group will follow their usual diet and receive similar study assessments and compensation.

The primary outcome at year one is MRI-assessed change in the amount of liver fat from baseline. At 24 months, the incidence of NAFLD in the intervention group vs. the control group will be assessed (primary outcome of the 24-month study). Other outcomes to be assessed at 12- and 24-months include changes in liver enzymes, glucose metabolism, dyslipidemia, body composition, and metabolomics.

These studies may inform the development of guidelines for clinicians, dietitians, parents, and others involved in counseling and caring for children at high risk of developing NAFLD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • At least one parent or the child self-identifies as Hispanic or Latino.
  • BMI ≥ 50th percentile for age and sex.
  • Age ≥ 6 years and ≤ 9 years
  • Tanner stage 1 by self and/or parental report
  • Normal ALT on screening labs (≤23 IU for girls, ≤26 IU for boys)
  • Written informed consent from parent or legal guardian, assent from child

排除标准

  • Known diagnosis of chronic liver disease other than NAFLD and "fatty liver"
  • History of significant depression
  • Implanted metal or other implant (braces ok), or claustrophobia or other reason that contraindicates MRI
  • Type 2 diabetes (Hemoglobin A1c > 6.4% on screening labs or chronic diagnosis)
  • Plans to move within the next 12 months
  • Current or previous participation in a weight loss program or obesity treatment program or clinic
  • Cancer or history of cancer
  • Recipient of a liver transplant
  • Chronic use (in the last year) of medications known to cause NAFLD or fatty liver (TPN, amiodarone, chronic oral steroids, etc.)
  • Intellectual disability or major psychiatric disorder limiting informed assent
  • At risk for eating disorder by screening instrument
  • Participants who are currently enrolled in a clinical trial or have received an investigational product within the last 60 days
  • Participants who are not able or willing to comply with the diet protocol or have any other condition or circumstance that would impede compliance or hinder completion of the study in the opinion of the investigator
  • Children who spend more than 1 night per week consistently in another household

研究组 & 干预措施

Low Free Sugar Diet (LFSD) Intervention

Experimental

The 1-year dietary intervention will be accomplished by adapting and extending a Social Cognitive Theory (SCT) guided low sugar intervention. SCT is a framework that helps explain how people regulate their behavior through control and reinforcement to achieve goal-directed behavior that can be maintained over time.

干预措施: LFSD (Behavioral)

Usual Care Control

No Intervention

Usual Care (Control group): Parents of enrolled children in the usual care group will be provided printed material on healthy family lifestyle at the beginning of the study. The control group will complete all of the same research visits and assessments as the intervention group.

结局指标

主要结局

Change in Percent Hepatic Steatosis by MRI-PDFF

时间窗: 12 month after start of intervention

The primary objective for the 12-month study is to test if an LFSD, compared to usual diet protects against increase in hepatic steatosis

Onset of NAFLD

时间窗: 24 months after start of intervention

The primary objective for the 24-month is to study to test if an LFSD protects against development of NAFLD (hepatic steatosis ≥ 5% and elevated ALT).

次要结局

  • Changes in markers of liver inflammation: ALT(Baseline, month 6, month 12, month 18, and month 24)
  • Changes in LDL(Baseline, Month 6, Month 12, month 18 and month 24)
  • Changes in BMI(Baseline, month 12 and month 24)
  • Changes in markers of liver inflammation: AST(Baseline, month 6, month 12, month 18, and month 24)
  • Changes in markers of liver inflammation: GGT(Baseline, month 12 and month 24)
  • Changes in HbA1c(Baseline, month 12 and month 24)
  • Changes in Fasting insulin(Measured at baseline, month 12 and month 24)
  • Changes in HDL(Baseline, Month 6, Month 12, month 18 and month 24)
  • Changes in Neck acanthosis nigricans(Baseline, month 12 and month 24)
  • Changes in fasting triglycerides(Baseline, Month 6, Month 12, month 18 and month 24)
  • Changes in waist hip ratio(Baseline, month 12 and month 24)
  • Changes Oral Glucose tolerance test (OGTT)(Baseline, month 12 and month 24)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean Welsh

Associate Professor

Emory University

研究点 (1)

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