Preventing Diabetes in the Deep South: Extending Partnerships and Adapting Interventions to Reach Rural Communities at High Risk.

Pre-diabetes Clinical Trial

Official title:

UAB Diabetes Research Center (DRC): Chronic Disease and the Reduction of Health Disparities Supplement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04343872
• Other study ID #: IRB-300005012
• Secondary ID: 3P30DK079626-12S
• Status: Completed
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Diabetes is responsible for a huge and growing burden of patient suffering and social costs, and the impact of this disease is shared disproportionately by minorities and in rural resource-challenged communities, particularly in the Deep South. To address this problem, the University of Alabama (UAB) Diabetes Research Center (DRC) will establish a primary care clinical network in rural counties of Alabama and in the Mississippi delta that will provide the (DRC) and its members with opportunities for partnership and the infrastructure to conduct translational and clinical research in those patients with the greatest need. A pilot trial will be conducted within the coalition to assess feasibility for a larger trial to evaluate a novel and sustainable approach for diabetes prevention that involves an innovative lifestyle intervention combined with metformin.

Description:

The pilot trial in aim three will include enrolling four primary care practices. Each of the participating practices will be randomized to one of two arms and accordingly enrolled participants from each clinic will be assigned to one of two conditions: Condition 1. Receive lifestyle modification alone (Diabetes Prevention Program (DPP). Condition 2. Receive lifestyle modification (DPP) with metformin therapy recommendation. Twenty five participants will be enrolled from each participating practice. Participants will be followed up for 12-14 months after recruitment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 19 to 65 years
• Body mass index (BMI) =30
• Receives care at one of the participating primary care clinics
• HbA1c 6.0% to 6.4%
• Resides in one location at least 5 days each week
• Willing to attend group-based classes
• Willing to work with a peer advisor in-person and over the phone
• Has regular access to telephone or cellular phone
• Willing and able to use telemonitoring body weight to conduct daily self-weighing
• Estimated Glomerular Filtration Rate (eGFR) of =60 in their medical record within 6 months

Exclusion Criteria:

• Diabetes diagnosis or HbA1c >6.4% or fasting glucose =126
• HbA1c <6.0%
• Pregnancy or anticipating pregnancy
• Unwilling or unable to do any of the following: give informed consent, accept random assignment, allow study staff to visit them at their primary care clinic for two follow-up visits
• Likely to relocate within next 6 months and no longer be seen at clinic within the next 12 months
• Weight loss =5% of body weight in past 6 months (other than postpartum)
• Past bariatric surgery
• Prescription weight loss medications within the past 6 months
• eGFR < 60 within past 6 months
• Unable to ambulate
• Have end-stage medical conditions with limited life expectancy

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pre-diabetes
• Prediabetic State

Intervention

Behavioral:
• Receive lifestyle modification alone
Participants will receive a 12-month lifestyle intervention program (telehealth + peer coach). The intervention comprises of the Center for Disease Control and Prevention (CDC)-adapted DPP Prevent Type 2 (PreventT2) lifestyle intervention program consisting of 26 classes delivered by trained health educators via telehealth. Additionally, the peer coach provides ongoing support over 12-months with tapered calls mirroring ongoing classes. Participants are randomized at the practice level. Two clinics will be randomized to receive the lifestyle intervention program alone.
• Metformin therapy
The two other clinics will be randomized to receive the lifestyle intervention program (described above) with METFORMIN therapy recommendations. Participants are randomized at the practice level. The primary care provider at the clinic will prescribe metformin and participants would be encouraged to take it if the primary care provider consider prescribing.

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight	Change in body weight from baseline to 12-months	12 months
Primary	Change in Glycosylated Hemoglobin (HbA1c)	Change in glycosylated hemoglobin (HbA1c) point of care test values	12 months