Diabetes Clinical Trial
Official title:
Pilot Study to Evaluate the Effects of Insulin Deprivation on Brain Structure and Function in Humans With Type 1 Diabetes
Verified date | February 2022 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
What are the effects of transient insulin deprivation on brain structure, blood flow, mitochondrial function, and cognitive function in T1DM patients? What are the effects of transient insulin deprivation on circulating exosomes and metabolites in T1DM patients?
Status | Completed |
Enrollment | 28 |
Est. completion date | July 5, 2019 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 45 Years |
Eligibility | Inclusion criteria: - Male and females age 14-17 years, females must be post-menarcheal - Age 18-45 years - Able to provide written consent - Parents able to provide written consent - T1DM treated with CSII or MDI (not degludec) Exclusion criteria: - BMI < 20 or > 30 kg/m2 - BMI z-score <5th or >95th percentile - Celiac disease - Pregnancy - Smoking - Reported history of illicit substance use - History of active cardiovascular, cerebrovascular, or peripheral vascular disease - Active renal disease evidenced by estimated GFR < 50 mL/min/1.73 m2 - History of traumatic brain injury - Dementia or any other neurologic disease - Psychiatric disease\ - Any learning disability - Hemoglobin A1c > 8.5% - Hemoglobin A1c > 9% - T2DM, or impaired fasting glucose |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Structural MRI | Structural magnetic resonance imaging (MRI) is a non-invasive technique for examining the anatomy and pathology of the brain (as opposed to using functional magnetic resonance imaging [fMRI] to examine brain activity. This produces images which can be used for clinical radiological reporting as well as for detailed analysis. | baseline, 6 hours |
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