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ACTIVE NOT RECRUITING
NCT05040087
NA

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

Sponsor: Foundation for Atlanta Veterans Education and Research, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

127

Start Date

2021-09-01

Completion Date

2027-03-31

Last Updated

2025-05-06

Healthy Volunteers

No

Conditions

Interventions

OTHER

Intensification of diabetes medication based largely on HbA1c levels

Use of diabetes Rx in controls will be guided largely by HbA1c levels.

OTHER

Intensification of diabetes medication based on glucose levels

Use of diabetes Rx in the intensive Rx groups will be guided by participants' self-monitored blood glucose levels (SMBG), with management aimed to keep glucose levels within the normal range.

Locations (1)

Atlanta VA Medical Center

Decatur, Georgia, United States