Status:
COMPLETED
Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients
Lead Sponsor:
Pennington Biomedical Research Center
Conditions:
Diabetes
Hypoglycemia
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
A recent pilot study, GLIMPSE (NCT02690168), was recently completed which demonstrated that the rate of glial acetate metabolism (GAM) is closely associated with susceptibility to fasting-induced hypo...
Eligibility Criteria
Inclusion
- Male or female
- Ages 18-40 years
- Diagnosed with type 1 diabetes with positive antibodies or dependent on insulin therapy
- HbA1c of ≤8.5%
- Modified Clarke's Hypoglycemia Questionnaire score of 12-24
- Willing to participate in continuous glucose monitoring (CGM)
Exclusion
- Contraindication to MRI
- Consume \>10 alcoholic drinks/week
- Current use of CGM
- Current use of insulin pump
- Current use of any diabetes medication other than insulin, e.g. SGLT1/2 inhibitors.
- Current use of steroids, e.g. cortisone, and prednisone.
- History of chronic smoking or have quit less than 10 years ago
- History of cancer in the past 5 years (individuals with basal cell or squamous cell skin cancer would be allowed)
- History of seizures
- Significant, cardiac, vascular, pulmonary, gastrointestinal, neurologic, hematologic, rheumatologic, or psychiatric disease
- Significant liver disease as defined as more than twice the upper limit of normal for liver enzymes
- Significant renal disease as defined as a estimated glomerular filtration rate less than 30
- Pregnant, planning to become pregnant, or breastfeeding
- Have been hospitalized or treated in the past 3 months for severe hypoglycemia
- Based on the investigative team's clinical judgement, a subject may not be appropriate for participation in the study.
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04430660
Start Date
August 19 2020
End Date
May 4 2022
Last Update
March 9 2023
Active Locations (2)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808-4124
2
Tulane Medical Center
New Orleans, Louisiana, United States, 70112