Changing the Natural History of Type 2 Diabetes ("CHANGE" Study)

Running, not enrolling · Not applicable

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT05040087

Run by

Foundation for Atlanta Veterans Education and Research, Inc.

People needed

127

Starts

2021-09-01

Expected to finish

2027-12-31

Last updated by the study team

2026-07-23

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosis of diabetes by OGTT
• age 40-75 years
• HbA1c 6.0-7.4%
• 1 hr OGTT glucose >155 mg/dl in each group

You may not qualify if…

• 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

Where it is running

• Atlanta VA Medical Center — Decatur, Georgia, United States

Full record on ClinicalTrials.gov

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