Status:
COMPLETED
Investigating the Role of the Polyol Pathway in the Central Nervous System
Lead Sponsor:
Yale University
Collaborating Sponsors:
American Diabetes Association
Conditions:
Hyperglycemia
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Patients will undergo magnetic resonance spectroscopy (MRS) scanning to noninvasively measure intracerebral and plasma metabolite levels at baseline and following 2 and 4 hours of hyperglycemia. Subje...
Eligibility Criteria
Inclusion
- Type 2 DM with HbA1C treated with metformin, sulfonylurea, insulin, or combination OR age-matched, non-diabetic obese (BMI \> 30 kg/m\^2) OR age-matched lean, healthy control subjects (BMI \< 25 kg/m\^2)
- Age 18-55
- BMI 18-45 kg/m\^2
Exclusion
- Creatinine \> 1.5 mg/dL
- Hgb \< 10 mg/dL
- ALT \> 2.5 x ULN
- Untreated thyroid disease
- Uncontrolled Hypertension
- Known Neurological Disorders
- Untreated Psychiatric Disorders
- Malignancy
- Bleeding Disorders
- Smoking
- Current or recent steroid use in last 3 months
- Illicit drug use
- Pregnancy, actively seeking pregnancy, or breastfeeding
- Inability to enter MRI/MRS
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2022
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT02272556
Start Date
February 1 2015
End Date
May 18 2022
Last Update
August 18 2022
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06519