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

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).

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Other names: CGM

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients: A Proof of Concept Study.

Acronym: GLEAM

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Jun 12, 2020
Registry last updated: Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed