Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT04074668
Eligibility Criteria:
Inclusion Criteria -- Type 1 Diabetes:
* Antibody positive Type 1 Diabetes with duration \> 5 years
* BMI between 18.5 and 30 kg/m2
* Weight \< 350 lbs
* HbA1c \< 11%
* Hemoglobin \>= 12 g/dl
Exclusion Criteria -- Type 1 Diabetes:
* Recent diagnosis (within 3 months) of Diabetic Ketoacidosis (DKA)
* Severe illness
* Pregnancy, nursing
* Anemia
* Allergy to shellfish or iodine
* Claustrophobia or implantable metal devices (MRI contraindications)
* High blood pressure (greater than 130/80 mm Hg)
* Elevated Urine Albumin-to-Creatinine Ratio (UACR) (\>30 mg/g) or estimated Glomerular Filtration Rate (eGFR) \<90 ml/min/1.73 m2
* Taking ACE inhibitors (ACEis), Angiotensin receptor blockers (ARBs), diuretics, Sodium Glucose Transporter (SGLT) 1/2 blockers
Inclusion Criteria -- Healthy Controls:
* No diagnosis of Type 1 or Type 2 Diabetes
* BMI between 18.5 and 30 kg/m2
* Weight \< 350 lbs
* HbA1c \< 11%
* Hemoglobin \>= 12 g/dl
Exclusion Criteria -- Healthy Controls:
* Severe illness
* Pregnancy, nursing
* Anemia
* Allergy to shellfish or iodine
* Claustrophobia or implantable metal devices (MRI contraindications)
* High blood pressure (greater than 130/80 mm Hg)
* Elevated UACR (\>30 mg/g) or eGFR \<90 ml/min/1.73 m2
* Taking ACE inhibitors (ACEis), Angiotensin receptor blockers (ARBs), diuretics, SGLT 1/2 blockers
Additional exclusion criteria for participants undergoing optional kidney biopsy:
* Evidence of bleeding disorder or complications from bleeding
* Use of aspirin, NSAIDS or other blood thinner that cannot be safely stopped for a sufficient time period before and after the biopsy so as to add no additional risk of bleeding
* Blood urea nitrogen (BUN) \> 80 gm/dL
* INR \> 1.4
* PTT \> 35 seconds
* Hemoglobin (Hgb) \< 10 mg/dL
* Platelet count \< 100,000 / µL
* Uncontrolled or difficult to control hypertension (\> 150/90 mmHg at the day of biopsy)
* eGFR \< 40 mL/min/1.73m2
* Single kidney (either by history, documented by prior imaging or ultrasound performed prior to the biopsy)
* \> 2 cm discrepancy between left and right kidney sizes based on largest longitudinal diameter determined by ultrasound performed prior to the biopsy.
* Kidney size: One or both kidneys \< 9 cm
* Hydronephrosis or other important renal ultrasound findings such as significant stone disease
* Any evidence of a current urinary tract infection as indicated on day of biopsy
* Clinical evidence of non-diabetic renal disease
* Positive urine pregnancy test or pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT04074668
Study Brief:
Protocol Section:
NCT04074668