Changing the Natural History of Type 2 Diabetes ("CHANGE" Study) (NCT05040087) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Changing the Natural History of Type 2 Diabetes ("CHANGE" Study)
United States127 participantsStarted 2021-09-01
Plain-language summary
Diabetes is a disorder of high blood glucose, that tends to get worse; over time, patients need more and more drugs. This pattern is caused by overwork of the body's insulin-producing β-cells, because patients' glucose levels are typically above normal; if the investigators kept glucose levels normal - reducing β-cell work - the investigators might be able to keep the disease from getting worse. This trial is aimed to show that adjusting the drugs to keep glucose levels normal, can help to preserve β-cell function compared to usual diabetes care, possibly reduce the tendency to develop the eye and kidney complications of diabetes, and might also be more cost-effective than usual care.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* diagnosis of diabetes by OGTT
* age 40-75 years
* HbA1c 6.0-7.4%
* 1 hr OGTT glucose \>155 mg/dl in each group
Exclusion Criteria:
* CVD event during the previous year
* systemic glucocorticoids
* bariatric surgery
* stage III-IV congestive heart failure
* severe angina
* life expectancy \<5 years
* BMI \>40 kg/m2
* pregnancy
* pancreatitis
* family or personal history of multiple endocrine neoplasia 2a
* an estimated glomerular filtration rate \[eGFR\] of ≤50 ml/min
* an alanine aminotransferase (ALT) level \>3x the upper limit of the normal range
* dementia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
EFFECT SIZE
Timeframe: 2.75 years (includes 3 month washout)
2
β-CELL FUNCTION - PRIMARY OUTCOME #2a
Timeframe: 2.75 years (includes 3 month washout)
3
β-CELL FUNCTION - PRIMARY OUTCOME #2b
Timeframe: 2.75 years (includes 3 month washout)
4
β-CELL FUNCTION - PRIMARY OUTCOME #2c.
Timeframe: 2.75 years (includes 3 month washout)
Trial details
NCT IDNCT05040087
SponsorFoundation for Atlanta Veterans Education and Research, Inc.