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ObesityNCT02412540

Controlled Trial of WLS vs. CLI for Severely Obese Adolescents With NASH

A study testing Comprehensive Lifestyle Intervention in people with Obesity and Nonalcoholic Steatohepatitis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to determine effective treatment and identify diagnostic biomarkers for Nonalcoholic steatohepatitis (NASH). Individuals that take part in the study will be participating in either a weight loss surgery (WLS) group or a comprehensive lifestyle intervention (CLI) group. Read more about this study

Who is it for?
Ages 12 to 19 years
What is being tested?
Comprehensive Lifestyle Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteUnited States
Study dates
23 Apr 2015to 2 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Adolescents ages 12-19 years (range as defined by World Health Organization).
  • BMI ≥ 35 to 69 kg/m2 (minimum BMI per current guidelines for WLS in adolescents). An upper limit of BMI was set to avoid rare outliers in BMI.
  • Meet current standard of care eligibility criteria for adolescent WLS.
  • Liver biopsy for clinical indication to evaluate for NASH within 1 year of enrollment. Biopsy must confirm definite or borderline NASH with a minimum histological NASH Activity Score of ≥ 3.
  • No evidence of any other liver disease by history, screening tests or histological evaluation.
  • Written informed consent from parent/legal guardian and informed assent from the adolescent

Who cannot join

  • Evidence of other chronic liver disease: autoimmune hepatitis; hepatitis B; hepatitis C; hemochromatosis; alpha-1-antitrypsin (A1AT) deficiency; Wilson disease; use of medications known to cause fatty liver for > 2 consecutive weeks in past year (i.e. systemic glucocorticoids, tetracycline, anabolic steroids, valproic acid); alcohol intake >10 gm/day females \& >20 gm/day males.
  • Non-compensated liver disease with any of the following: hemoglobin <10 g/dL; white blood cell count <3,500 cells/mm3, platelet count <130,000 cells/mm3 of blood, direct bilirubin >1.0 mg/dL, total bilirubin >3 mg/dL, albumin <3.2 g/dL, international normalized ratio (INR) >1.4
  • Active psychiatric disorder that would prevent eligibility for WLS or impede adherence to CLI, including clinically significant depression (hospitalization or suicidal ideation) in past 12 months.
  • Any medical condition preventing eligibility for WLS including but not limited to micronutrient deficiencies (e.g. iron) refractory to medical therapy or inflammatory bowel disease.
  • Poorly controlled Type 2 diabetes mellitus (T2DM) defined as hemoglobin A1C (HgbA1c) > 10%.
  • Initiation of high dose vitamin E (>400 IU per day) or other medications which could alter NASH histology at any time after baseline liver biopsy or during the trial. Stable dose of vitamin E that was started 12 months or more prior to biopsy is allowed.
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  • Weight reduction of >5% between baseline liver biopsy and enrollment, as weight loss >5% may change NASH severity.
  • Inability or failure to provide informed assent/consent
  • Current enrollment in another clinical trial or receipt of an investigational study drug within 6 months prior to the baseline liver biopsy
  • Any female who is currently nursing, planning a pregnancy, known or suspected to be pregnant, or has a positive pregnancy screen
  • Inability to travel to study site at intervals necessary for clinical interventions (CLI or WLS).
  • Prior history of WLS.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: A Parallel Cohort Controlled Trial of Outcome of Nonalcoholic Steatohepatitis in Adolescents After Bariatric Surgery vs. Comprehensive Lifestyle Intervention (NASH ABC)

The goal of this study is to determine effective treatment and identify diagnostic biomarkers for Nonalcoholic steatohepatitis (NASH). Individuals that take part in the study will be participating in either a weight loss surgery (WLS) group or a comprehensive lifestyle intervention (CLI) group. People in the WLS group will receive vertical sleeve gastrectomy (VSG). The CLI group will receive dietary, activity and behavioral interventions provided by trained study staff.

Read the detailed description

The investigators have designed a rigorously controlled study designed to evaluate NASH outcomes in two parallel cohorts: 1) severely obese adolescents with NASH who have chosen to undergo WLS (specifically VSG) for clinical indications compared to 2) a control group of severely obese adolescents with NASH enrolled in a CLI offered as part of this study. The study will provide the best evidence to date of the effectiveness of WLS and CLI in treating NASH in adolescents with body mass index (BMI) ≥ 35 kg/m2. The investigators will also concurrently collect health-care utilization data to enable subsequent cost-effectiveness analyses (CEA) to evaluate the cost-effectiveness of WLS vs. CLI intervention in severely-obese adolescents with NASH. If the investigators' data support our hypothesis that WLS yields superior results, this will set the stage for randomized studies (if needed) and translational studies of weight loss-independent biological mechanism(s) unique to WLS, which may include specific changes in bile acid signaling and in the intestinal microbiome. The latter would facilitate developing novel pharmacotherapies accessible to younger or less obese children with NASH to whom WLS is not applicable. Cumulatively, this study has the potential to yield significant improvements in medical and quality of life (QOL) outcomes for a large proportion of pediatric patients with NASH and to reduce long term health care costs by identifying effective treatment options and decreasing progression to cirrhosis and end-stage liver disease.

Being tested
Comprehensive Lifestyle Intervention
Medical subject headings
Obesity, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comprehensive Lifestyle InterventionBehavioural

    Dietary, behavioral and activity interventions designed to reduce weight.

Study groups in NCT02412540
Study groupRoleWhat they receive
Weight Loss SurgeryNo interventionAdolescents who will have Weight Loss Surgery and had biopsy-confirmed NASH. The Weight Loss Surgery is not part of the study. The investigators are following the adolescents after the surgery.
Comprehensive Lifestyle InterventionExperimentalComprehensive Lifestyle Intervention - Dietary, activity and behavioral interventions. Adolescents who have biopsy-confirmed NASH and wish to participate in a Comprehensive Lifestyle Intervention (26+ contact hours) including individual meetings with a study dietitian, group nutrition classes, behavior management modules and physical activity goals.
Receives: Behavioral: Comprehensive Lifestyle Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Histology Endpoint: Proportion of subjects achieving greater than 2 point reduction in NASH activity score (NAS)

    Proportion of subjects achieving greater than 2 point reduction in NASH activity score (NAS) across at least two separate histological components of the NAS score (steatosis, inflammation and ballooning) and no worsening of fibrosis stage.

    Measured: 12 months

  2. Biomarker Endpoint

    Correlation between presence or absence of histological NASH and combined magnetic resonance (MR) measures and serum cytokeratin 18 (CK18) levels at baseline and 12 month follow-up.

    Measured: 12 months

Secondary outcomes (7)

  1. Resolution of NASH: Proportion of subjects achieving "not NASH" histological diagnosis

    Proportion of subjects achieving "not NASH" histological diagnosis at the end of the study.

    Measured: 12 months

  2. Reduction in mean NAS

    decrease in overall histological activity as measured by reduction in mean NAS.

    Measured: 12 months

  3. Decrease in steatosis

    Decrease in NAS score

    Measured: 12 months

  4. Composite decrease in weight

    Decrease in BMI, weight and waist circumference.

    Measured: 12 months

  5. Composite Quality of Life (QOL) Measures

    Change in generic health-related and weight-specific QOL measures Pediatric Quality of Life Inventory and Impact of Weight on Quality of Life (IWQOL-Kids©)).

    Measured: 12 months

  6. Liver enzymes

    Decrease in serum alanine (ALT) \& asparate aminotransferase (AST), gamma-glutamyl trans-peptidase (GGT) level.

    Measured: 12 months

  7. Liver enzymes

    Normalization of ALT (defined as <26 U/L for males and <22 U/L for females).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2015 (estimated)
  2. Study start23 Apr 2015
  3. Primary completion2 Mar 2021
  4. Study completion2 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02412540
Sponsor's protocol ID
NASH ABC
Status last verified
Nov 2021
First submitted
1 Apr 2015
Last updated
2 Nov 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Yodoshi T, Ollberding NJ, McNeill M, Ley SL, Kirk S, Kleiner DE, Arce-Clachar AC, Bramlage K, Inge TH, Helmrath MA, Cecil KM, Trout AT, Elder DA, Mouzaki M, Xanthakos SA. Vertical Sleeve Gastrectomy Versus Comprehensive Lifestyle Intervention for Adolescents With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Prospective Controlled Cohort Study. Aliment Pharmacol Ther. 2026 Jun 8. doi: 10.1111/apt.70766. Online ahead of print.

    PubMed 42259766

Questions about this trial

What is this clinical trial studying?

A study testing Comprehensive Lifestyle Intervention in people with Obesity and Nonalcoholic Steatohepatitis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Histology Endpoint: Proportion of subjects achieving greater than 2 point reduction in NASH activity score (NAS) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02412540, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.

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