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NCT05040087Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 12 Aug 2026

Brief summary (registry, in English)

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 (registry)
Active, not recruiting
Study type
Interventional
Enrollment
127 (actual)
First submitted
27 Aug 2021
Start date
1 Sept 2021
Primary completion date
31 Dec 2026
Lead sponsor
Foundation for Atlanta Veterans Education and Research, Inc.
NCT number
NCT05040087

What you commit to

  • Study type: Interventional
  • Participants enrolled: 127
  • From 1 Sept 2021 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • CVD event during the previous year
  • bariatric surgery

Other illness

  • stage III-IV congestive heart failure
  • severe angina
  • family or personal history of multiple endocrine neoplasia 2a
  • dementia

Lab values

  • an estimated glomerular filtration rate \[eGFR\] of ≤50 ml/min
  • an alanine aminotransferase (ALT) level \>3x the upper limit of the normal range

Age

  • life expectancy \<5 years

Other

  • systemic glucocorticoids
  • BMI \>40 kg/m2
  • pregnancy
  • pancreatitis

Who the study is looking for

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

Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Atlanta VA Medical Center
Coordinator of this site? Confirm its status
DecaturUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.