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

Diabetes Clinical Trial

— GLEAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04430660
• Other study ID #: PBRC 2018-060
• Status: Completed
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: May 4, 2022

Study information

• Verified date: March 2023
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 4, 2022
• Est. primary completion date: March 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Hypoglycemia

Intervention

Other:
• 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.

Device:
• 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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Tulane Medical Center	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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