Pre-diabetesNCT04343872
Preventing Diabetes in the Deep South: Extending Partnerships and Adapting Interventions to Reach Rural Communities at High Risk.
A study testing Receive lifestyle modification alone and Metformin therapy in people with Pre-diabetes, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Receive lifestyle modification alone and Metformin therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2020to 31 Dec 2022
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: UAB Diabetes Research Center (DRC): Chronic Disease and the Reduction of Health Disparities Supplement
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.
Read the detailed 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.
- Conditions
- Pre-diabetes
- Being tested
- Receive lifestyle modification alone, Metformin therapy
- Keywords
- Obesity, Metformin Therapy
- Medical subject headings
- Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receive lifestyle modification aloneBehavioural
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 therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Receive lifestyle modification alone (DPP) | Active comparator | Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services Receives: Behavioral: Receive lifestyle modification alone |
| Receive lifestyle modification with metformin therapy | Experimental | Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services plus metformin recommendation Receives: Behavioral: Receive lifestyle modification alone; Behavioral: Metformin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Change in body weight from baseline to 12-months
Measured: 12 months
Change in Glycosylated Hemoglobin (HbA1c)
Change in glycosylated hemoglobin (HbA1c) point of care test values
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start10 Dec 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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 Pre-diabetesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Cherrington, MD, University of Alabama at Birmingham
- Investigators
- Andrea Cherrington, MD, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343872
- Sponsor's protocol ID
- IRB-300005012
- Other IDs
- 3P30DK079626-12S1
- Status last verified
- Feb 2024
- First submitted
- 7 Apr 2020
- Last updated
- 5 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UAB Diabetes Research Center (DRC): Chronic Disease and the Reduction of Health Disparities Supplement
- ClinicalTrials.gov ID
- NCT04343872
- Acronym / sponsor ID
- IRB-300005012
- Conditions
- Pre-diabetes
- Keywords
- Obesity, Metformin Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Posted 5 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receive lifestyle modification alone (DPP) | Active comparator | Behavioral: Receive lifestyle modification aloneParticipants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services |
| Receive lifestyle modification with metformin therapy | Experimental | Behavioral: Receive lifestyle modification alone, Behavioral: Metformin therapyParticipants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services plus metformin recommendation |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Receive lifestyle modification aloneParticipants 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. | Behavioural | Receive lifestyle modification alone (DPP), Receive lifestyle modification with metformin therapy |
| Metformin therapyThe 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. | Behavioural | Receive lifestyle modification with metformin therapy |
Primary outcome
Change in Body Weight
Time frame: 12 months
Change in body weight from baseline to 12-months
Change in Glycosylated Hemoglobin (HbA1c)
Time frame: 12 months
Change in glycosylated hemoglobin (HbA1c) point of care test values
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Andrea Cherrington, MD, MPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receive lifestyle modification alone and Metformin therapy in people with Pre-diabetes, run by University of Alabama at Birmingham 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 10 inclusion and 11 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 5 Mar 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 5 Mar 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?
Change in Body Weight (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2024.