| NCT ID | NCT05026723 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-10-04 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2021-10-04 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single-site, open-label, Phase II, community-based randomized controlled explanatory trial to test the efficacy of a medically tailored meal + intensive lifestyle intervention (MTM + ILI) intervention for adults with food insecurity, HIV, and T2DM or high risk of T2DM, compared with a group that receives usual MTM.
Eligibility Criteria
Inclusion Criteria * Male or female * Diagnosis of HIV * Diagnosis of Type 2 Diabetes Mellitus or high risk for type 2 diabetes mellitus, defined as meeting CDC eligibility criteria for the diabetes prevention program. Specifically, an individual without a diagnosis of T2DM must 1) have had a blood test result in the prediabetes range within the past year (Hemoglobin A1C: 5.7-6.4% OR Fasting plasma glucose: 100-125 mg/dL OR Two-hour plasma glucose \[after a 75 g glucose load\]: 140-199 mg/dL), 2) Have been previously diagnosed with gestational diabetes, OR 3) have a high-risk result (score of 5 or higher) on the Prediabetes Risk Test (https://www.cdc.gov/prediabetes/pdf/Prediabetes-Risk-Test-Final.pdf) * Experiencing food insecurity as indicated by 2-item Hunger Vital Sign * English speaking * Aged ≥18 years * BMI ≥ 23 kg/m2 * No plans to move from the area for at least 1 year * Free living to the extent that participant has control over dietary intake * Willing and able to provide written informed consent and participate in all study activities Exclusion Criteria: * Participant in diabetes, nutrition, or weight research intervention in last 12 months * Current AIDS defining illness * Another family member or household member is a study participant. Only one member of each household may take part in this study. * Considering bariatric surgery in the next year or prior bariatric surgery in the past 2 years * Lack of safe, stable residence and ability to store meals * Lack of telephone * Pregnancy/breastfeeding or intended pregnancy in the next year * History of malignancy, other than non-melanoma skin cancer, unless surgically or medically cured \> 5 years ago or in remission. Patients with localized prostate and breast cancer diagnosed during the course of routine screening will not be excluded. * Advanced kidney disease (estimated creatinine clearance \< 30 ml/min) * Known drug or alcohol misuse in the past 6 months * Known psychosis or major psychiatric illness that prevents participation with study activities * Intermittent use of medications (e.g., oral or intravenous glucocorticoids) that are likely to affect blood sugar
Contact & Investigator
Seth A Berkowitz, MD, MPH
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT05026723 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05026723 currently recruiting?
Yes, NCT05026723 is actively recruiting participants. Contact the research team at kathier1@email.unc.edu for enrollment information.
Where is the NCT05026723 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT05026723 clinical trial?
NCT05026723 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Seth A Berkowitz, MD, MPH at University of North Carolina, Chapel Hill. The trial plans to enroll 200 participants.
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