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NCT04430660 | COMPLETED | Diabetes

Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients
Sponsor:

Pennington Biomedical Research Center

Information provided by (Responsible Party):

David McDougal

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).

Condition or disease

Diabetes

Hypoglycemia

Intervention/treatment

13C-MRS procedure/Acetate infusion

Continuous glucose monitoring

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 8 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients: A Proof of Concept Study.
Actual Study Start Date : 2020-08-19
Estimated Primary Completion Date : 2022-03-29
Estimated Study Completion Date : 2022-05-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients

Location Details

NCT04430660

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How to Participate

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Locations

Not yet recruiting

United States, Louisiana

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808-4124

Not yet recruiting

United States, Louisiana

Tulane Medical Center

New Orleans, Louisiana, United States, 70112