Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetes Mellitus NAFLD

Outcome Measures

Primary Outcomes (5)

Feasibility as Measured by Recruitment Rate
The Investigator will assess recruitment rates: Patients eligible and sent letter of message / Patients enrolled
3 months
Feasibility as Measured by Retention Rate
The team will assess retention rates: Patients enrolled / Patients completing study
3months
Feasibility as Measured by Visit Completion Rate
The Investigator assess visit completion rates: Total study visits completed / Total study visits scheduled
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.
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.

Secondary Outcomes (8)

Change in Self-Efficacy Measured by the Managing Chronic Diseases (SEMCD) Score
Baseline, 3months
Change in Autonomy Support Measured by the Modified Health Care Climate Questionnaire (HCCQ)
Baseline, 3months
Change in Physical Health Quality of Living as Measured by the 12-Item Short Form Health Survey (SF-12)
Baseline, 3months
Change in Mental Health Quality of Living as Measured by the SF-12
Baseline, 3months
Change in Mean Hemoglobin A1c (HbA1c)
Baseline, 3months
+3 more secondary outcomes

Study Arms (1)

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

Behavioral: NAFLD EducationBehavioral: diet/lifestyle supportDrug: T2D medication managementDiagnostic Test: clinically-indicated liver testing and care

Interventions

NAFLD EducationBehavioral

NAFLD Education

Evidence-based care of NAFLD in T2D

diet/lifestyle supportBehavioral

diet/lifestyle support

Evidence-based care of NAFLD in T2D

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Duke University
Otherlead

Study Sites (1)

Duke University Healthcare System

Durham, North Carolina, 27710, United States

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseDiabetes Mellitus

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

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.

Results Point of Contact

Title: Anastasia Alexopoulos
Organization: Duke University

Study Officials

Anastasia-Stefania Alexopoulos, MD
Duke University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 6, 2023

Study Start

September 18, 2023

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (8)

Study Arms (1)

Evidence-based care of NAFLD in T2D

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (8)

Study Arms (1)

Evidence-based care of NAFLD in T2D

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations