NAFLDNAFLD-DMNCT05844137

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

A study testing NAFLD Education, diet/lifestyle support and T2D medication management in people with NAFLD and Diabetes Mellitus, run by Duke University 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

Who is it for?: Ages 18 years and older
Conditions the study is for: NAFLD, Diabetes Mellitus
What is being tested?: NAFLD Education, diet/lifestyle support and T2D medication management
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 18 Sep 2023to 29 Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Healthcare System
Durham, North Carolina, 27710

Other trials in United States

About this study

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

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.

Conditions: NAFLD, Diabetes Mellitus
Being tested: NAFLD Education, diet/lifestyle support, T2D medication management, clinically-indicated liver testing and care
Medical subject headings: Non-alcoholic Fatty Liver Disease, Diabetes Mellitus

What participants receive

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

NAFLD EducationBehavioural
NAFLD Education
diet/lifestyle supportBehavioural
diet/lifestyle support
T2D medication managementDrug
T2D medication management
clinically-indicated liver testing and careDiagnostic test
clinically-indicated liver testing and care

Study groups in NCT05844137
Study group	Role	What they receive
Evidence-based care of NAFLD in T2D	Experimental	Intervention content will include: 1) NAFLD education; 2) diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care Receives: Behavioral: NAFLD Education; Behavioral: diet/lifestyle support; Drug: T2D medication management; Diagnostic Test: clinically-indicated liver testing and care

What is being measured

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

Feasibility as Measured by Recruitment Rate
The Investigator will assess recruitment rates: Patients eligible and sent letter of message / Patients enrolled
Measured: 3 months
Feasibility as Measured by Retention Rate
The team will assess retention rates: Patients enrolled / Patients completing study
Measured: 3months
Feasibility as Measured by Visit Completion Rate
The Investigator assess visit completion rates: Total study visits completed / Total study visits scheduled
Measured: 3months
Feasibility of System-level NAFLD Detection Approach
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.
Measured: Baseline
Acceptability of Intervention by Participants
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.
Measured: 3months

Secondary outcomes (8)

Change in Self-Efficacy Measured by the Managing Chronic Diseases (SEMCD) Score
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.
Measured: Baseline, 3months
Change in Autonomy Support Measured by the Modified Health Care Climate Questionnaire (HCCQ)
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.
Measured: Baseline, 3months
Change in Physical Health Quality of Living as Measured by the 12-Item Short Form Health Survey (SF-12)
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.
Measured: Baseline, 3months
Change in Mental Health Quality of Living as Measured by the SF-12
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.
Measured: Baseline, 3months
Change in Mean Hemoglobin A1c (HbA1c)
Change of >/= 0.5% will be deemed clinically significant
Measured: Baseline, 3months
Change in Mean Alanine Aminotransferase (ALT) Level
Change of >/= 5 IU/mL will be deemed clinically significant.
Measured: Baseline, 3months
Number of Participants With Changes to Medications During the Study Period Measured by Chart Review
Measured: baseline, 3 months
Number of Participants in Whom Clinically-indicated Tests Were Ordered (e.g. Labs, Referral, Imaging).
Measured: baseline, 3 months

Timeline

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

18 Sep 202329 Jan 2024

First posted6 May 2023
Study start18 Sep 2023
Primary completion29 Jan 2024
Study completion29 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NAFLDStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05844137
Sponsor's protocol ID: Pro00113239
Acronym: NAFLD-DM
Status last verified: Sep 2024
First submitted: 25 Apr 2023
Last updated: 27 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: NA- IPD will not be made available to other researchers

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1
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RecruitingPhase 2
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All NAFLD trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes (NAFLD-DM): A Pilot Study
ClinicalTrials.gov ID: NCT05844137
Acronym / sponsor ID: NAFLD-DM / Pro00113239
Conditions: NAFLD, Diabetes Mellitus
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: 18 Sep 2023 (actual)
Primary completion: 29 Jan 2024 (actual)
Study completion: 29 Jan 2024 (actual)
First posted: 6 May 2023 (actual)
Results: Posted 27 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Evidence-based care of NAFLD in T2D	Experimental	Behavioral: NAFLD Education, Behavioral: diet/lifestyle support, Drug: T2D medication management, Diagnostic Test: clinically-indicated liver testing and careIntervention content will include: 1) NAFLD education; 2) diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NAFLD EducationNAFLD Education	Behavioural	Evidence-based care of NAFLD in T2D
diet/lifestyle supportdiet/lifestyle support	Behavioural	Evidence-based care of NAFLD in T2D
T2D medication managementT2D medication management	Drug	Evidence-based care of NAFLD in T2D
clinically-indicated liver testing and careclinically-indicated liver testing and care	Diagnostic test	Evidence-based care of NAFLD in T2D

Primary outcome

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
Feasibility as Measured by Retention Rate
Time frame: 3months
The team will assess retention rates: Patients enrolled / Patients completing study
Feasibility as Measured by Visit Completion Rate
Time frame: 3months
The Investigator assess visit completion rates: Total study visits completed / Total study visits scheduled
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.
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.

8 secondary outcomes

Change in Self-Efficacy Measured by the Managing Chronic Diseases (SEMCD) Score
Time frame: Baseline, 3months
Change in Autonomy Support Measured by the Modified Health Care Climate Questionnaire (HCCQ)
Time frame: Baseline, 3months
Change in Physical Health Quality of Living as Measured by the 12-Item Short Form Health Survey (SF-12)
Time frame: Baseline, 3months
Change in Mental Health Quality of Living as Measured by the SF-12
Time frame: Baseline, 3months
Change in Mean Hemoglobin A1c (HbA1c)
Time frame: Baseline, 3months
Change in Mean Alanine Aminotransferase (ALT) Level
Time frame: Baseline, 3months
Number of Participants With Changes to Medications During the Study Period Measured by Chart Review
Time frame: baseline, 3 months
Number of Participants in Whom Clinically-indicated Tests Were Ordered (e.g. Labs, Referral, Imaging).
Time frame: baseline, 3 months

Results and safety

Results posted to the registry on 27 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Evidence-based Care of NAFLD in T2D	10	10

Primary outcome: Feasibility as Measured by Recruitment Rate

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Evidence-based Care of NAFLD in T2D n = 51
Recruitment by Cold Call	8
Recruitment by MyChart	2

Population analysed: This outcome includes all patients that were approached for recruitment either by cold call or MyChart messages.

Primary outcome: Feasibility as Measured by Retention Rate

Time frame: 3months. Count of participants. Unit: Participants

Measure	Evidence-based Care of NAFLD in T2D n = 10
Value	10

Primary outcome: Feasibility as Measured by Visit Completion Rate

Time frame: 3months. Number. Unit: number of study visits

Measure	Evidence-based Care of NAFLD in T2D n = 10
Value	30

Population analysed: There were 3 study visits per participant so 30 total study visits.

Primary outcome: Feasibility of System-level NAFLD Detection Approach

Time frame: Baseline. Number. Unit: patient charts reviewed

Measure	Evidence-based Care of NAFLD in T2D n = 184
Value	122

Population analysed: This outcome includes potentially eligible participants identified prior to enrollment. The charts of 184 patients were reviewed and 122 patients were ultimately found to be eligible.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Evidence-based Care of NAFLD in T2D	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): Due to resources constraints, we did not achieve our target number of participants. We did not conduct effect size calculations or inferential statistics due to the small sample size and pilot nature of this study. Further, larger studies will be necessary to examine the effectiveness of this approach - across broader racial and ethnic identities - and to determine the effectiveness of this intervention (versus usual care) on clinically-relevant outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. NA- IPD will not be made available to other researchers

Related trials for NAFLD

Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
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Recruiting
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RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
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RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anastasia-Stefania Alexopoulos, MD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NAFLD Education, diet/lifestyle support and T2D medication management in people with NAFLD and Diabetes Mellitus, run by Duke University 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 3 inclusion and 4 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 27 Dec 2024. 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?

Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility as Measured by Recruitment Rate (time frame: 3 months). The study lists 5 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 NCT05844137.

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 27 Dec 2024.