Trial · NCT07911033
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Total Composite Cardiovascular Disease (CVD) Endpoint | Up to 37 years. | Time from study baseline to the first instance of CVD death, myocardial infarction (MI), coronary revascularization, blockage ≥50%, ischemic ECG at study visit, study physician-diagnosed angina, or stroke. Participants not experiencing CVD will be censored at their last event-free follow-up. |
| Primary | Time to First Instance of Severely Increased Albuminuria (SIA) | Up to 30 years. | Time from study baseline to the first instance of albumin excretion rate ≥200 µg/min or albumin-creatinine ratio ≥300 mg/g in ≥2 of 3 timed urine specimens (24-hour, overnight, 4 hour clinic specimen). Participants not experiencing SIA will be censored at their last event-free follow-up. |
| Primary | Time to Sustained Estimated Glomerular Filtration Rate (eGFR) Decline | Up to 30 years. | Time from study baseline to the first instance of two consecutive visits with eGFR\<60 ml/min/1.73m\^2. Participants not experiencing sustained eGFR decline will be censored at their last event-free follow-up. |
| Primary | Proportion of Participants Experiencing Level 3 Hypoglycemia | Up to 37 years. | Count of severe hypoglyemia events characterized by altered mental and/or physical status requiring assistance. |
| Primary | Coronary Artery Calcification (CAC) Score | Measured at 41 years. | Participants with a CAC Agatston score \>100, which is considered moderate or greater coronary plaque build-up, indicating an increased risk of heart disease. |
| Primary | Carotid-Femoral Pulse Wave Velocity (cfPWV) Measurement | Measured at 41 years. | Participants with a cfPWV \> 10 m/s. |
| Primary | Estimated Glomerular Filtration Rate (eGFR) Measurement | Measured at 41 years. | eGFR calculated using serum creatinine. |
| Secondary | Time to First Major Adverse Cardiovascular Event (MACE) | Up to 37 years. | Time from study baseline to the first instance of CVD death, MI, or stroke. Participants not experiencing MACE will be censored at their last event-free follow-up. |
| Secondary | Time to First Total Coronary Artery Disease (tCAD) Event | Up to 37 years. | Time from study baseline to the first instance of CAD death, MI, coronary revascularization, ischemic ECG at study visit, or study physician-diagnosed angina. Participants not experiencing tCAD will be censored at their last event-free follow-up. |
| Secondary | Time to First Hard Coronary Artery Disease (hCAD) Event | Up to 37 years. | Time from study baseline to the first instance of CAD death, MI, or coronary revascularization. Participants not experiencing hCAD will be censored at their last event-free follow-up. |
| Secondary | Time to First Instance of Moderately Increased Albuminuria (MIA) | Up to 30 years. | Time from study baseline to the first instance of albumin excretion rate 20-200 µg/min or albumin-creatinine ratio 30-300 mg/g in ≥2 of 3 timed urine specimens (24-hr, overnight, 4 hr clinic specimen). Participants not experiencing MIA will be censored at their last event-free follow-up. |
| Secondary | Time to First Instance of Proliferative Diabetic Retinopathy (PDR) | Up to 30 years. | Time from study baseline to the first instance of ETDRS grade ≥60 on retinal fundus photos or laser photocoagulation for PDR. Participants not experiencing PDR will be censored at their last event-free follow-up. |
| Secondary | Time to First Instance of Distal Symmetric Polyneuropathy (DSP) | Up to 30 years. | Time from study baseline to the first instance of the presence of two or more of the following as assessed by a study physician: DSP symptoms, sensory and/or motor signs, and/or absent (or present only with reinforcement) tendon reflexes. Participants not experiencing DSP will be censored at their last event-free follow-up. |
| Secondary | Time to First Instance of Autonomic Neuropathy (AN) | Up to 30 years. | Time from study baseline to the first instance of AN. AN is assessed using heart rate response to deep breathing (expiration to inspiration ratio). A ratio of \<1.1 is considered AN. Participants not experiencing AN will be censored at their last event-free follow-up. |
| Secondary | Time to First Instance of Lower Extremity Arterial Disease (LEAD) | Up to 30 years. | Resting ankle-brachial systolic blood pressures are taken in the supine position with a Doppler blood-flow detector. Ankle-to-brachial index (ABI) is calculated using the brachial pressure measurement taken closest in time to the ankle (right and left tibialis posterior and dorsalis pedis) pressures. LEAD is defined as the first instance of ABI \< 0.8 on either side at rest, and/or a history of claudication as determined by questionnaire, and/or self-reported history of amputation for ischemia. Participants not experiencing LEAD will be censored at their last event-free follow-up. |
| Secondary | Time to First Instance of End-Stage Kidney Disease (ESKD) | Up to 37 years. | Time from study baseline to the first instance of renal dialysis or kidney transplant. Participants not experiencing ESKD will be censored at their last event-free follow-up. |
| Secondary | Urinary Albumin to Creatinine Ratio (UACR) Measurement | Measured at 41 years. | Participants with UACR (median from 3 timed urine specimens: 2 overnight, 4-hour clinic specimen) \> 30 mg/g. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07911033/registered