DiabetesNCT03839511
Use of a Hyperinsulinemic-hypyglycemic Clamp to Study Hypoglycemia: a Method Development Study
An observational study of Diabetes, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
A hyperinsulinemic-hypoglycemic clamp is an experimental procedure, which allows for hypoglycemia to be studied in a safe and controlled manner. The goal of this study is to establish the hyperinsulinemic-hypoglycemic clamp procedure at Pennington Biomedical Research Center in order to apply the knowledge gained to… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Hyperinsulinemic-hypoglycemic clamp
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2018to 8 Feb 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult
Study population: We will enroll up to 8 healthy men or women (goal n=3 completers) in this method development study.
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
- History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL
- Average screening blood pressure >140/90 mmHg
- History of cardiovascular disease
- Pregnant, planning to become pregnant, or breastfeeding
- 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
A hyperinsulinemic-hypoglycemic clamp is an experimental procedure, which allows for hypoglycemia to be studied in a safe and controlled manner. The goal of this study is to establish the hyperinsulinemic-hypoglycemic clamp procedure at Pennington Biomedical Research Center in order to apply the knowledge gained to future studies which will determine the efficacy of our biomarker for predicting susceptibility to hypoglycemia. Additionally, our use of continuous glucose monitoring (CGM) during the clamp procedure will provide novel data regarding the accuracy of CGM during hypoglycemic conditions in a controlled research setting.
- Conditions
- Diabetes
- Being tested
- Hyperinsulinemic-hypoglycemic clamp
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperinsulinemic-hypoglycemic clampProcedure or surgery
Subjects will arrive at the inpatient unit in the morning after at least a 10 hour overnight fast. Upon arrival to PBRC, participants will be admitted to the inpatient unit. Following measurement of weight, vitals, and pregnancy test (women only), the 4-hour hypoglycemic clamp procedure (30 minute baseline, 120 minute insulin infusion, and 90 minute recovery) will be performed. Upon completion of the clamp procedure, participants will be provided lunch (Standard American Diet). Following lunch, the CGM sensor will be removed and pending a stable blood glucose level in the normal range, the participant will be discharged from the inpatient unit. This completes the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Epinephrine Levels
This value represents the average peak epinephrine value measured during the hypoglycemic clamp procedure
Measured: 90 minute interval following initiation of insulin infusion
Secondary outcomes (1)
CGM Glucose
This value represents the average glucose values measured via continuous glucose monitoring during the hypoglycemic clamp procedure
Measured: 90 minute interval following initiation of insulin infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start28 Nov 2018
- Primary completion8 Feb 2019
- Study completion8 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 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
- NCT03839511
- Sponsor's protocol ID
- 2018-050-PBRC HYPOCLAMP
- Status last verified
- Jul 2021
- First submitted
- 11 Feb 2019
- Last updated
- 19 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Hyperinsulinemic-hypyglycemic Clamp to Study Hypoglycemia: a Method Development Study
- ClinicalTrials.gov ID
- NCT03839511
- Acronym / sponsor ID
- 2018-050-PBRC HYPOCLAMP
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Posted 19 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A hyperinsulinemic-hypoglycemic clamp is an experimental procedure, which allows for hypoglycemia to be studied in a safe and controlled manner. The goal of this study is to establish the hyperinsulinemic-hypoglycemic clamp procedure at Pennington Biomedical Research Center in order to apply the knowledge gained to future studies which will determine the efficacy of our biomarker for predicting susceptibility to hypoglycemia. Additionally, our use of continuous glucose monitoring (CGM) during the clamp procedure will provide novel data regarding the accuracy of CGM during hypoglycemic conditions in a controlled research setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- We will enroll up to 8 healthy men or women (goal n=3 completers) in this method development study.
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 (5 listed)
- History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL
- Average screening blood pressure >140/90 mmHg
- History of cardiovascular disease
- Pregnant, planning to become pregnant, or breastfeeding
- Based on the investigative team's clinical judgement, a subject may not be appropriate for participation in the study.
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 clampSubjects will arrive at the inpatient unit in the morning after at least a 10 hour overnight fast. Upon arrival to PBRC, participants will be admitted to the inpatient unit. Following measurement of weight, vitals, and pregnancy test (women only), the 4-hour hypoglycemic clamp procedure (30 minute baseline, 120 minute insulin infusion, and 90 minute recovery) will be performed. Upon completion of the clamp procedure, participants will be provided lunch (Standard American Diet). Following lunch, the CGM sensor will be removed and pending a stable blood glucose level in the normal range, the participant will be discharged from the inpatient unit. This completes the study. | Procedure or surgery | – |
Primary outcome
Peak Epinephrine Levels
Time frame: 90 minute interval following initiation of insulin infusion
This value represents the average peak epinephrine value measured during the hypoglycemic clamp procedure
1 secondary outcome
CGM Glucose
Time frame: 90 minute interval following initiation of insulin infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, 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 5 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 19 Aug 2021. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Peak Epinephrine Levels (time frame: 90 minute interval following initiation of insulin infusion). 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 19 Aug 2021.