DiabetesGLEAMNCT04430660
Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients
A study testing 13C-MRS procedure/Acetate infusion and Continuous glucose monitoring in people with Diabetes and Hypoglycemia, run by Pennington Biomedical Research Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Diabetes, Hypoglycemia
- What is being tested?
- 13C-MRS procedure/Acetate infusion and Continuous glucose monitoring
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Aug 2020to 4 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808-4124
Tulane Medical Center
New Orleans, Louisiana, 70112
About this study
Official title: Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients: A Proof of Concept Study.
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
- Being tested
- 13C-MRS procedure/Acetate infusion, Continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C-MRS procedure/Acetate infusionOther
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 monitoringDevice
Also called CGM
Participants will wear blinded continuous glucose monitoring devices (dexcom, G6) for approximately 4 weeks. Sensors will be replaced every 7-10 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 13C-MRS procedure/Acetate infusion; Device: Continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS)
Measured: Once at Study Visit 1 day and 1 day at Study Visit 3, 14 days apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start19 Aug 2020
- Primary completion29 Mar 2022
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David McDougal, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430660
- Sponsor's protocol ID
- PBRC 2018-060
- Acronym
- GLEAM
- Status last verified
- Mar 2023
- First submitted
- 16 Jan 2020
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients: A Proof of Concept Study.
- ClinicalTrials.gov ID
- NCT04430660
- Acronym / sponsor ID
- GLEAM / PBRC 2018-060
- Conditions
- Diabetes, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Other: 13C-MRS procedure/Acetate infusion, Device: Continuous glucose monitoringParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13C-MRS procedure/Acetate infusionGlial 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. | Other | Arm 1 |
| Continuous glucose monitoringAlso: CGMParticipants will wear blinded continuous glucose monitoring devices (dexcom, G6) for approximately 4 weeks. Sensors will be replaced every 7-10 days. | Device | Arm 1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 13C-MRS procedure/Acetate infusion and Continuous glucose monitoring in people with Diabetes and Hypoglycemia, run by Pennington Biomedical Research Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.