Status:
COMPLETED
Insulin Deprivation on Brain Structure and Function in Humans With Type 1 Diabetes
Lead Sponsor:
Mayo Clinic
Conditions:
Diabetes Mellitus, Type 1
Diabetes
Eligibility:
All Genders
14-45 years
Phase:
NA
Brief Summary
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 depriv...
Detailed Description
Diabetes is associated with impaired cognition, abnormal brain development in children, and dementia in older adults, however the underlying mechanisms remain unclear. Little is known about the brain-...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03392441
Start Date
November 30 2017
End Date
July 5 2019
Last Update
February 3 2022
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905