Type 2 Diabetes Clinical Trial
— CHANGEOfficial title:
Changing the Natural History of Type 2 Diabetes ("CHANGE" Study)
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.
Status | Recruiting |
Enrollment | 126 |
Est. completion date | June 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 74 Years |
Eligibility | Inclusion Criteria: - diagnosis of diabetes by OGTT - age 40-74 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 |
Country | Name | City | State |
---|---|---|---|
United States | Atlanta VA Medical Center | Decatur | Georgia |
Lead Sponsor | Collaborator |
---|---|
Foundation for Atlanta Veterans Education and Research, Inc. | Abbott Diabetes Care, Emory University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Phillips LS, Ratner RE, Buse JB, Kahn SE. We can change the natural history of type 2 diabetes. Diabetes Care. 2014 Oct;37(10):2668-76. doi: 10.2337/dc14-0817. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EFFECT SIZE | HbA1c DIFFERENCEs, INTENSIVE Rx vs. CONTROLS - PRIMARY OUTCOME #1 | 2.75 years (includes 3 month washout) | |
Primary | ß-CELL FUNCTION - PRIMARY OUTCOME #2a | ß-cell function from modeling using a 3-hour OGTT with samples for glucose, insulin and C-peptide at 10, -5, 10, 20, 30, 60, 90, 120, 150 and 180 minutes. | 2.75 years (includes 3 month washout) | |
Primary | ß-CELL FUNCTION - PRIMARY OUTCOME #2b | ß-cell function and insulin sensitivity as the oral "OGTT ISI disposition index" (DI), using the "insulinogenic index" [(? insulin/? glucose) with 0- and 30-minute insulin (and C-peptide) and glucose levels in the OGTT] for insulin secretion and [1/(fasting insulin concentration)] for insulin action. | 2.75 years (includes 3 month washout) | |
Primary | ß-CELL FUNCTION - PRIMARY OUTCOME #2c. | ß-cell function as the 1 hour OGTT plasma glucose (1hrOGTT). | 2.75 years (includes 3 month washout) | |
Secondary | RETINOPATHY determined by fundus photographs | Assessed with fundus photos graded by readers masked to study groups. The University of Wisconsin Fundus Photograph Reading Center (FPRC) is grading photos for the DPPOS. Under Co-I Dr. Maa's direction, and with dilation, 4 sets of stereo ETDRS-level photos with 45° fields will be taken with a Zeiss Cirrus 600 camera by FPRC-certified VA technologists. Deidentified images will be uploaded via secure OneDrive, and accessed by the FPRC. | 2.5 years | |
Secondary | NEPHROPATHY by eGFR | The development of nephropathy will be assessed with the eGFR according to the CKD-EPI equation, measured in the Atlanta VA Clinical Laboratory, in samples obtained at baseline, and every 6 months through 2.5 years. | 2.5 years | |
Secondary | NEPHROPATHY by urine microalbumin/creatinine ratio | The development of nephropathy will be assessed with the urine microalbumin/creatinine ratio, measured in the Atlanta VA Clinical Laboratory, in samples obtained at baseline, and every 6 months through 2.5 years. | 2.5 years | |
Secondary | Point of care glucose by continuous glucose monitoring (CGM) | After 3 weeks of MOVE! and maximum tolerated dosage of each Rx in intensive Rx subjects, 14 days of CGM will permit ROC analysis to compare AG vs. SMBG in predicting need for more Rx, and use of the Youden index to define an optimal glucose cutoff. We will also assess prediction of needing the first vs. later Rx; ROC areas should be independent of disease prevalence. | 2.5 years | |
Secondary | COST EFFECTIVENESS - to be explored only if additional (ancillary) funding can be obtained | We will use a microsimulation model to extrapolate the glycemic reduction with intensive Rx observed in the trial to the potential reduction in DM complications and related costs in a lifetime window. | 2.5 years |
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