Status:
WITHDRAWN
Reversibility of Brain Glucose Transport and Metabolism in T2DM: an Intervention Study
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Diabete Type 2
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This study is designed to test if there is a difference in brain glucose transport kinetics in poorly controlled T2DM individuals with short duration and long duration of diabetes, using non-invasive ...
Detailed Description
Specific Aim 1: To compare brain glucose transport and metabolism in age, BMI, and HbA1c matched T2DM individuals with either long duration of diabetes or short duration of diabetes using brain 1H MRS...
Eligibility Criteria
Inclusion
- Type 2 Diabetics with HbA1c \> 7.5% with short duration of diabetes \<5 years or
- Type 2 Diabetics with HbA1c \> 7.5% longer duration of diabetes \>5 years
Exclusion
- Patients treated with incretin-based therapies
- Creatinine \> 1.5 mg/dL
- Hgb \< 10 mg/dL
- ALT \> 3 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
- Women: pregnancy, actively seeking pregnancy, or breastfeeding
- Inability to enter MRI/MRS (per standard MRI safety guidelines)
Key Trial Info
Start Date :
October 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04283617
Start Date
October 12 2021
End Date
March 1 2024
Last Update
February 16 2024
Active Locations (1)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520