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

Primary Purpose

Diabetes, Hypoglycemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
13C-MRS procedure/Acetate infusion
Continuous glucose monitoring
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pennington Biomedical Research Center
  • Tulane Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 16, 2020
Last Updated
March 7, 2023
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT04430660
Brief Title
Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients
Acronym
GLEAM
Official Title
Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients: A Proof of Concept Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
March 29, 2022 (Actual)
Study Completion Date
May 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypoglycemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
13C-MRS procedure/Acetate infusion
Intervention Description
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
Device
Intervention Name(s)
Continuous glucose monitoring
Other Intervention Name(s)
CGM
Intervention Description
Participants will wear blinded continuous glucose monitoring devices (dexcom, G6) for approximately 4 weeks. Sensors will be replaced every 7-10 days.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808-4124
Country
United States
Facility Name
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States

12. IPD Sharing Statement

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

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