DiabetesE-VALNCT04207619
Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation
A study testing hyperinsulinemic-hypoglycemic clamp and 13C-MRS procedure/Acetate infusion in people with Diabetes and Hypoglycemia, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
Hypoglycemic complications are a major impediment to the maintenance of healthy glucose levels in persons with diabetes. The investigators recently completed a clinical pilot and feasibility study (GLIMPSE, NCT02690168), which identified a novel biomarker, glial acetate metabolism, that appears to predict the… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Hypoglycemia
- What is being tested?
- hyperinsulinemic-hypoglycemic clamp and 13C-MRS procedure/Acetate infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2020to Oct 2027
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female
- Ages 18-40 years
- BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)
- Medically cleared for participation in the study
Who cannot join
- Contraindication to MRI
- Consume >10 alcoholic drinks/week
- History of chronic smoking or have quit less than 10 years ago
- History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL
- Average screening blood pressure >140/90 mmHg
- History of cardiovascular disease
Show all 10Show fewer
- Pregnant, planning to become pregnant, or breastfeeding
- Use of medications affecting glucose metabolism, e.g., benzodiazepines, thiazide diuretics, cortisone, and prednisone.
- Use of beta-adrenergic antagonists.
- Based on the investigative team's clinical judgement, a subject may not be appropriate for participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808-4124
About this study
Official title: Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation Using 13C Magnetic Resonance Spectroscopy.
Hypoglycemic complications are a major impediment to the maintenance of healthy glucose levels in persons with diabetes. The investigators recently completed a clinical pilot and feasibility study (GLIMPSE, NCT02690168), which identified a novel biomarker, glial acetate metabolism, that appears to predict the susceptibility to hypoglycemia. By providing an assay to predict hypoglycemic events and therefore diabetic complications, the development of this biomarker could significantly improve the treatment of persons with diabetes.
The goal of this study is to determine the efficacy of our biomarker for predicting susceptibility to insulin-induced hypoglycemia. In order to accomplish this goal the investigatiors will pair our 13C magnetic resonance spectroscopy procedure to assess glial acetate metabolism, developed in the GLIMPSE study, with a hyperinsulinemic-hypoglycemic clamp procedure, developed in the HYPOCLAMP study (NCT03839511). The two procedures will be separated by a three day interval. The investigators will then correlate the participants' rates of glial acetate metabolism with their neuroendocrine responses to the hypoglycemic clamp. This proof of concept study will test the hypothesis that glial acetate metabolism is inversely proportional to the neuroendocrine response to hypoglycemia, that is, as glial acetate metabolism increases the neuroendocrine response will decrease.
- Conditions
- Diabetes, Hypoglycemia
- Being tested
- hyperinsulinemic-hypoglycemic clamp, 13C-MRS procedure/Acetate infusion
- 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.
hyperinsulinemic-hypoglycemic clampOther
An intravenous catheter will be placed in an antecubital vein for infusion of insulin and glucose. A second catheter will be placed retrograde in a dorsal vein of the contra-lateral hand for blood withdrawal. The hand will be placed in a heating box or pad at 70°C for arterialization of venous blood. A primed infusion of regular insulin (120 mU/min/m2) will be initiated and continued for approximately 2 hours. Beginning 20 minutes prior to the start of the insulin infusion, arterialized venous blood glucose will be measured at 5 minute intervals via a Hemocue or YSI analyzer. Following initiation of insulin infusion, blood glucose will be allowed to fall to 50 mg/dL and then maintained at this level using a variable infusion of exogenous dextrose (20% solution). Our goal is to achieve steady-state (blood glucose stabilized at 50 +/- 5 mg/dL) within the first 45 minutes following the start of insulin infusion.
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants will have their glial acetate metabolism measured by carbon-13 magnetic resonance spectroscopy as well as their neuroendocrine response to hypoglycemia 3 days later. Receives: Other: hyperinsulinemic-hypoglycemic clamp; Other: 13C-MRS procedure/Acetate infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS)
Glial acetate metabolism
Measured: Every ten minutes for 120 minutes following administration of 1-13C acetate
Secondary outcomes (1)
Change in serum epinephrine levels
The change is serum epinephrine during the hypoglycemic clamp will be determined relative to baseline levels
Measured: epinephrine will be measured every 15 minutes for 135 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start19 Feb 2020
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Why it stopped: Study activities are temporarily on hold. Recruitment may resume in the future.
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
- 10 participants (estimated)
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
- Investigators
- David McDougal, PhD, Principal investigator, PBRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207619
- Sponsor's protocol ID
- PBRC 2019-047
- Acronym
- E-VAL
- Status last verified
- Sep 2026
- First submitted
- 17 Dec 2019
- Last updated
- 17 Sep 2026
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation Using 13C Magnetic Resonance Spectroscopy.
- ClinicalTrials.gov ID
- NCT04207619
- Acronym / sponsor ID
- E-VAL / PBRC 2019-047
- Conditions
- Diabetes, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study activities are temporarily on hold. Recruitment may resume in the future.
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 23 Dec 2019 (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.
Hypoglycemic complications are a major impediment to the maintenance of healthy glucose levels in persons with diabetes. The investigators recently completed a clinical pilot and feasibility study (GLIMPSE, NCT02690168), which identified a novel biomarker, glial acetate metabolism, that appears to predict the susceptibility to hypoglycemia. By providing an assay to predict hypoglycemic events and therefore diabetic complications, the development of this biomarker could significantly improve the treatment of persons with diabetes.
The goal of this study is to determine the efficacy of our biomarker for predicting susceptibility to insulin-induced hypoglycemia. In order to accomplish this goal the investigatiors will pair our 13C magnetic resonance spectroscopy procedure to assess glial acetate metabolism, developed in the GLIMPSE study, with a hyperinsulinemic-hypoglycemic clamp procedure, developed in the HYPOCLAMP study (NCT03839511). The two procedures will be separated by a three day interval. The investigators will then correlate the participants' rates of glial acetate metabolism with their neuroendocrine responses to the hypoglycemic clamp. This proof of concept study will test the hypothesis that glial acetate metabolism is inversely proportional to the neuroendocrine response to hypoglycemia, that is, as glial acetate metabolism increases the neuroendocrine response will decrease.
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 | Experimental | Other: hyperinsulinemic-hypoglycemic clamp, Other: 13C-MRS procedure/Acetate infusionParticipants will have their glial acetate metabolism measured by carbon-13 magnetic resonance spectroscopy as well as their neuroendocrine response to hypoglycemia 3 days later. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female
- Ages 18-40 years
- BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)
- Medically cleared for participation in the study
Key exclusion criteria (10 listed)
- Contraindication to MRI
- Consume >10 alcoholic drinks/week
- History of chronic smoking or have quit less than 10 years ago
- History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL
- Average screening blood pressure >140/90 mmHg
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 |
|---|---|---|
| hyperinsulinemic-hypoglycemic clampAn intravenous catheter will be placed in an antecubital vein for infusion of insulin and glucose. A second catheter will be placed retrograde in a dorsal vein of the contra-lateral hand for blood withdrawal. The hand will be placed in a heating box or pad at 70°C for arterialization of venous blood. A primed infusion of regular insulin (120 mU/min/m2) will be initiated and continued for approximately 2 hours. Beginning 20 minutes prior to the start of the insulin infusion, arterialized venous blood glucose will be measured at 5 minute intervals via a Hemocue or YSI analyzer. Following initiation of insulin infusion, blood glucose will be allowed to fall to 50 mg/dL and then maintained at this level using a variable infusion of exogenous dextrose (20% solution). Our goal is to achieve steady-state (blood glucose stabilized at 50 +/- 5 mg/dL) within the first 45 minutes following the start of insulin infusion. | Other | Arm 1 |
| 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 |
Primary outcome
Percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS)
Time frame: Every ten minutes for 120 minutes following administration of 1-13C acetate
Glial acetate metabolism
1 secondary outcome
Change in serum epinephrine levels
Time frame: epinephrine will be measured every 15 minutes for 135 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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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.
David McDougal, PhD principal investigator
PBRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperinsulinemic-hypoglycemic clamp and 13C-MRS procedure/Acetate infusion in people with Diabetes and Hypoglycemia, run by Pennington Biomedical Research Center at 1 site 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 4 inclusion and 10 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: paused, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS) (time frame: Every ten minutes for 120 minutes following administration of 1-13C acetate). 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 17 Sep 2026.