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

NCT04430660 | Completed

• 1 other identifier: PBRC 2018-060
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change in percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS)

  Once at Study Visit 1 day and 1 day at Study Visit 3, 14 days apart

Study Arms (1)

Arm 1

OTHER

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.

Other: 13C-MRS procedure/Acetate infusion; Device: Continuous glucose monitoring

Interventions

13C-MRS procedure/Acetate infusion 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.

Arm 1

Continuous glucose monitoring DEVICE

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

Also known as: CGM

Arm 1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (2)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808-4124, United States

Location

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: June 12, 2020
• Study Start: August 19, 2020
• Primary Completion: March 29, 2022
• Study Completion: May 4, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

US (2)