Status:
COMPLETED
Evaluation of Coffee Therapy for Improvement of Renal Oxygenation
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Type1diabetes
Type1 Diabetes Mellitus
Eligibility:
All Genders
12-21 years
Phase:
PHASE2
Brief Summary
Over 1.25 million Americans have Type 1 Diabetes (T1D), increasing risk for early death from cardiovascular disease (CVD). Despite advances in glycemic and blood pressure control, a child diagnosed wi...
Eligibility Criteria
Inclusion
- Youth with T1D (antibody +) with \<10 year duration
- Age 12-21 years
- Weight \>57 lbs and \<350 lbs
- BMI \>5th %ile
- HbA1c \<12%
- Previous exposure to caffeine
Exclusion
- Anemia
- Allergy to shellfish or iodine
- Severe illness, recent diabetic ketoacidosis (DKA)
- Tachyarrhythmias, Attention-deficit/hyperactivity disorder (ADHD), tremors, tics, Tourette's, arrythmias, insomnia, overactive bladder
- Estimated Glomerular Filtration Rate (eGFR) \<60 ml/min/1.73 m2 or creatinine \> 1.5 mg/dl or history of albumin-to-creatinine ratio (ACR) \>300 mg/g
- MRI Scanning contraindications (claustrophobia, implantable metal devices that are non-MRI compatible, \>350 lbs)
- Pregnancy or nursing
- (Angiotensin-converting enzyme) ACE inhibitors, angiotensin receptor blockers (ARBs), diuretics, sodium-glucose co-transport (SGLT) 2 or 1 blockers, daily NSAIDs or aspirin, sulfonamides, thiazolsulfone or probenecid, atypical antipsychotics, steroids
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03878277
Start Date
July 1 2019
End Date
September 30 2021
Last Update
February 15 2022
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045