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NCT Number: NCT05370781

Michigan Men's Diabetes Project 2

The Michigan Men's Diabetes Project 2 (MenD 2) is an 18-month pilot randomized clinical trial. We are looking to recruit 60 Black men with type 2 diabetes (need to have diagnosis for at least 6 months) that are over the age of 21. Interested participants need to be under the care of a physician for their diabetes, have access to reliable transportation for study activities, and be willing to participate in 4 health assessments where they will get their A1C, blood pressure, height, and weight measured and they will complete a survey. All participants will receive 10 hours of diabetes self-management education with a Certified Diabetes Care and Education Specialist. Participants randomized to the intervention arm will also be offered 6 months of monthly diabetes self-management support (DSMS) sessions with trained Peer Leaders who are also Black men with type 2 diabetes. After the 6 months of support, this group will transition into 6 months of ongoing support where they can continue DSMS and/or other diabetes related initiatives that are important to the group and chosen by the group. Due to the COVID-19 pandemic, DSME and DSMS sessions will likely be held via Zoom, ongoing support sessions have potential to be in person. The 4 health assessments will take place at baseline, 3-months, 9-months, and 15-months.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Black/African American males, age 21 years or older with diagnosis of T2D for six months, transportation to attend program activities, under the care of a physician for diabetes, and willing to attend group delivered sessions.

Exclusion criteria

  • We considered restricting eligibility to a higher-risk population of participants with A1c ≥ 8%. Preliminary data suggest that over 50% of the proposed study sample will have an A1c ≥ 8%. Focusing on all older Black men with T2D allows us to cast a wide net for secondary prevention and public health impact.

Treatment and study plan

Peer Led Diabetes Self-Management Support

Behavioral

While the effectiveness of peer-led interventions delivering diabetes-related education and support for short-term clinical, psychosocial, and behavioral improvements is well-established, older Black men in particular are less likely to participate and are at a higher risk of drop-out from these studies. This intervention aims to determine if using older Black men as peer leaders to other older Black men will improve retention rates for this population.

Diabetes Self-Management Education

Behavioral

Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom platform.

Primary outcomes

  1. Change in Hemoglobin A1c

    Time frame: baseline, 3-months, 9-months, 15-months

    Anthropometric/clinical data

  2. Change in Regimen Adherence

    Time frame: baseline, 3-months, 9-months, 15-months

    Survey data

Secondary outcomes

  1. Change in Depression

    Time frame: baseline, 3-months, 9-months, 15-months

    survey data

  2. Change in Body Mass Index

    Time frame: baseline, 3-months, 9-months, 15-months

    Anthropometric data/clinical data

  3. Change in Blood Pressure

    Time frame: baseline, 3-months, 9-months, 15-months

    Anthropometric data/clinical data

  4. Change in Diabetes Social Support

    Time frame: baseline, 3-months, 9-months, 15-months

    survey data

  5. Change in Diabetes-Related Distress

    Time frame: baseline, 3-months, 9-months, 15-months

    survey data

  6. Change in Diabetes Quality of Life

    Time frame: baseline, 3-months, 9-months, 15-months

    survey data

  7. Change in Adherence to gender norms

    Time frame: baseline, 3-months, 9-months, 15-months

    survey data

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: MenD 2

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 12, 2022
Registry last updated
Sep 10, 2025

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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