Status:
COMPLETED
Control of Renal Oxygen Consumption, Mitochondrial Dysfunction, and Insulin Resistance
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Diabetic Kidney Disease
Type 1 Diabetes
Eligibility:
All Genders
18-30 years
Brief Summary
Type 1 diabetes (T1D) is a complex metabolic disorder with many pathophysiological disturbances including insulin resistance (IR) and mitochondrial dysfunction which are causally related to the develo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 15 2022
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04074668
Start Date
January 1 2020
End Date
November 15 2022
Last Update
February 9 2023
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045