Clinical trial NCT04430660: Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients
Official title: Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients: A Proof of Concept Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypoglycemia
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 hypoglycemia in healthy adults. Insulin-induced hypoglycemia is a common complication of diabetes treatment and is a major barrier to the maintenance of healthy glucose levels in individuals with diabetes. The primary purpose of the study is to test the proof-of-concept that there is an association between the rate of GAM and susceptibility to insulin-induced hypoglycemia. In order to observe such a relationship the rate of GAM will be measured in a patient population known to frequently experience hypoglycemia, i.e., individuals with type 1 diabetes mellitus (T1DM).


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS)
timeFrame: Once at Study Visit 1 day and 1 day at Study Visit 3, 14 days apart
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
Study officials:
References: