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

NCT ID: NCT04430660

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-19
• Study Completion Date: 2022-05-04

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).

Conditions

Diabetes; Hypoglycemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Arm 1

Participants will have there glial acetate metabolism assessed via 13C MRS at baseline and then again 14 days later. Participants will wear blinded continuous glucose monitoring devices for \~4 weeks.

Group Type: OTHER

13C-MRS procedure/Acetate infusion

Intervention Type: OTHER

Glial metabolism will be measured via MRS utilizing a simultaneous intravenous infusion of 13C labeled acetate. An intravenous catheter will be placed in a vein of each arm, one to infuse 13C-acetate and the other to draw blood samples.

Continuous glucose monitoring

Intervention Type: DEVICE

Participants will wear blinded continuous glucose monitoring devices (dexcom, G6) for approximately 4 weeks. Sensors will be replaced every 7-10 days.

Interventions

13C-MRS procedure/Acetate infusion

Glial metabolism will be measured via MRS utilizing a simultaneous intravenous infusion of 13C labeled acetate. An intravenous catheter will be placed in a vein of each arm, one to infuse 13C-acetate and the other to draw blood samples.

Intervention Type: OTHER

Continuous glucose monitoring

Participants will wear blinded continuous glucose monitoring devices (dexcom, G6) for approximately 4 weeks. Sensors will be replaced every 7-10 days.

Intervention Type: DEVICE

Other Intervention Names

CGM

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

David McDougal

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Tulane Medical Center

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

PBRC 2018-060

Identifier Type: -

Identifier Source: org_study_id