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Completed

NCT Number: NCT05844137

Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes

The primary objective of this pilot study is to assess the feasibility and acceptability of an intervention for improved detection and evidence-based care of NAFLD in Latinx and Black patients with type 2 diabetes (T2D) in Duke University Healthcare system (DUHS). We will enroll 10-15 Latinx and 10-15 Black patients with T2D and NAFLD, based on having mildly elevated liver enzymes (ALT >/= 40 IU/mL in males, ALT >/= 31 IU/mL in females) and exclusion of other liver diseases (e.g., viral hepatitis, alcohol abuse).

Intervention content will include: 1) NAFLD education; 2)diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care.

Intervention feasibility will be evaluated by examining recruitment rates, retention rates, and study visit completion rates. Acceptability will be assessed by survey and through qualitative interviews. The project objectives and intervention are minimal risk. The expected risks will not exceed those of usual care.

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Key information

Conditions

NAFLD Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Healthcare System

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People who identify as either: Latino/Latina/Hispanic ethnicity and/or Black or African American race
  • People with type 2 diabetes (T2D), as defined by ICD-10 codes E11.xx.
  • Patients with elevated serum alanine aminotransferase (ALT) within Duke University Healthcare System (DUHS). Elevated ALT will be defined as having at least two ALT ≥40 IU/mL in males or ≥31 IU/mL in females in the preceding 12 months

Exclusion criteria

  • People with hepatitis B or C infection
  • People with known alcohol overuse
  • People with current use of chemotherapy or other drugs known to affect liver function
  • People who have not been seen by a DUHS Primary Care Physician (PCP) or Endocrinologist in the preceding year.

Treatment and study plan

NAFLD Education

Behavioral

NAFLD Education

diet/lifestyle support

Behavioral

diet/lifestyle support

T2D medication management

Drug

T2D medication management

clinically-indicated liver testing and care

Diagnostic Test

clinically-indicated liver testing and care

Primary outcomes

  1. Feasibility as Measured by Recruitment Rate

    Time frame: 3 months

    The Investigator will assess recruitment rates: Patients eligible and sent letter of message / Patients enrolled

  2. Feasibility as Measured by Retention Rate

    Time frame: 3months

    The team will assess retention rates: Patients enrolled / Patients completing study

  3. Feasibility as Measured by Visit Completion Rate

    Time frame: 3months

    The Investigator assess visit completion rates: Total study visits completed / Total study visits scheduled

  4. Feasibility of System-level NAFLD Detection Approach

    Time frame: Baseline

    Measure by the number of patients who met criteria for NAFLD after chart review / total number of potentially-eligible patients based on our EHR criteria.

  5. Acceptability of Intervention by Participants

    Time frame: 3months

    The Investigator will calculate the mean and standard deviation of the Treatment Acceptability and Preferences (TAP);Minimum value = 0; Maximum value = 4; Higher score is a better outcome (ie more acceptable). The Investigator define acceptable score as mean TAP ≥ 3.

Secondary outcomes

  1. Change in Self-Efficacy Measured by the Managing Chronic Diseases (SEMCD) Score

    Time frame: Baseline, 3months

    The SEMCD is a 6-item scale with a total minimum value = 1; a total maximum value = 10; Higher score is a better outcome (ie greater self-efficacy). Will be measured by a change of >/=1.

  2. Change in Autonomy Support Measured by the Modified Health Care Climate Questionnaire (HCCQ)

    Time frame: Baseline, 3months

    The HCCQ is a 5-item scale with a total minimum value = 1; a total maximum value = 5; Higher score is a better outcome (ie greater self-management)

    Will be measured by a change of >/=1 as being clinically significant.

  3. Change in Physical Health Quality of Living as Measured by the 12-Item Short Form Health Survey (SF-12)

    Time frame: Baseline, 3months

    The SF-12 is a 5-item scale with a total minimum value = 0; a total maximum value = 100; Higher score is a better outcome (ie greater quality of life)

    Will be measured by a change of >/=10 as being clinically significant.

  4. Change in Mental Health Quality of Living as Measured by the SF-12

    Time frame: Baseline, 3months

    The SF-12 is a 5-item scale with a total minimum value = 0; a total maximum value = 100; Higher score is a better outcome (ie greater quality of life)

    Will be measured by a change of >/=10 as being clinically significant.

  5. Change in Mean Hemoglobin A1c (HbA1c)

    Time frame: Baseline, 3months

    Change of >/= 0.5% will be deemed clinically significant

  6. Change in Mean Alanine Aminotransferase (ALT) Level

    Time frame: Baseline, 3months

    Change of >/= 5 IU/mL will be deemed clinically significant.

  7. Number of Participants With Changes to Medications During the Study Period Measured by Chart Review

    Time frame: baseline, 3 months

  8. Number of Participants in Whom Clinically-indicated Tests Were Ordered (e.g. Labs, Referral, Imaging).

    Time frame: baseline, 3 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes (NAFLD-DM): A Pilot Study

Acronym: NAFLD-DM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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