Insulin SensitivityNCT06216665
Effect of Pulsatile Hormone Administration on Insulin Action
A study testing Continuous Insulin administration during hyperinsulinemic euglycemic clamp test and Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test in people with Insulin Sensitivity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
In humans, insulin is secreted in pulses from the pancreatic beta-cells, and these oscillations help to maintain fasting plasma glucose levels within a narrow normal range. Given the fluctuations in insulin concentrations, oscillations enhance precision of control. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Insulin Sensitivity
- What is being tested?
- Continuous Insulin administration during hyperinsulinemic euglycemic clamp test and Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2024to 9 May 2024
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of the Motivate Study (NCT05649176)
Who cannot join
- Non-completion of the end-of-study hyperinsulinemic euglycemic clamp test of the Motivate study
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
In humans, insulin is secreted in pulses from the pancreatic beta-cells, and these oscillations help to maintain fasting plasma glucose levels within a narrow normal range. Given the fluctuations in insulin concentrations, oscillations enhance precision of control. The hyperinsulinemic euglycemic clamp test (clamp) involves a continuous infusion of insulin and is the gold standard for measuring insulin sensitivity. In this study, insulin sensitivity measured using the standard clamp will be compared with a clamp in which the same total amount of insulin as the standard clamp is infused every five minutes instead of continuously.
Read the detailed description
Participants with obesity and insulin resistance completing a randomized, controlled, two-arm parallel trial (Motivate) will be enrolled in this cross-sectional study. Twelve participants from the Motivate study will return within two weeks to complete two clamp tests within a week of each other. At these clamps, the insulin will be infused continuously at a dose of 40mU/m2/min during the first clamp test and the same total amount of insulin will be infused every five minutes at the second clamp. The day following the clamps, participants will return to the clinic in a fasted state and blood will be drawn for measurement of glucose and insulin.
- Conditions
- Insulin Sensitivity
- Being tested
- Continuous Insulin administration during hyperinsulinemic euglycemic clamp test, Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Insulin administration during hyperinsulinemic euglycemic clamp testOther
Participants will receive insulin delivered continuously during the hyperinsulinemic euglycemic clamp test
Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp testOther
Participants will receive insulin delivered every five minutes during the hyperinsulinemic euglycemic clamp test
| Study group | Role | What they receive |
|---|---|---|
| Continuous insulin at 40mU/m2/min | Active comparator | Paricipants will receive insulin infused continuously during the hyperinsulinemic euglycemic clamp test of insulin sensitivity. Receives: Other: Continuous Insulin administration during hyperinsulinemic euglycemic clamp test |
| Pulsatile insulin at 40mU/m2/min | Experimental | Participants will receive insulin infused every five minutes during the hyperinsulinemic euglycemic clamp test of insulin sensitivity Receives: Other: Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Glucose infusion rate during the hyperinsulinemic euglycemic clamp test
Measured: One day
Secondary outcomes (1)
Insulin resistance
Homeostasis Model Assessment of Insulin Resistance
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start4 Mar 2024
- Primary completion9 May 2024
- Study completion9 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin SensitivityStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Participants receive insulin delivered continuously or every five minutes during the hyperinsulinemic euglycemic clamp test
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candida Rebello, Pennington Biomedical Research Center
- Investigators
- Candida Rebello, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216665
- Sponsor's protocol ID
- PBRC 2023-018
- Status last verified
- Jan 2025
- First submitted
- 11 Jan 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rebello CJ, Morales TS, Chuon K, Dong S, Lam VT, Purner D, Lewis S, Lakey J, Beyl RA, Greenway FL. Physiologic hormone administration improves HbA1C in Native Americans with type 2 diabetes: A retrospective study and review of insulin secretion and action. Obes Rev. 2023 Dec;24(12):e13625. doi: 10.1111/obr.13625. Epub 2023 Aug 14.
PubMed 37580916
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulsatile Hormone Administration on Insulin Action
- ClinicalTrials.gov ID
- NCT06216665
- Acronym / sponsor ID
- PBRC 2023-018
- Conditions
- Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 9 May 2024 (actual)
- Study completion
- 9 May 2024 (actual)
- First posted
- 22 Jan 2024 (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.
In humans, insulin is secreted in pulses from the pancreatic beta-cells, and these oscillations help to maintain fasting plasma glucose levels within a narrow normal range. Given the fluctuations in insulin concentrations, oscillations enhance precision of control. The hyperinsulinemic euglycemic clamp test (clamp) involves a continuous infusion of insulin and is the gold standard for measuring insulin sensitivity. In this study, insulin sensitivity measured using the standard clamp will be compared with a clamp in which the same total amount of insulin as the standard clamp is infused every five minutes instead of continuously.
Detailed description
Participants with obesity and insulin resistance completing a randomized, controlled, two-arm parallel trial (Motivate) will be enrolled in this cross-sectional study. Twelve participants from the Motivate study will return within two weeks to complete two clamp tests within a week of each other. At these clamps, the insulin will be infused continuously at a dose of 40mU/m2/min during the first clamp test and the same total amount of insulin will be infused every five minutes at the second clamp. The day following the clamps, participants will return to the clinic in a fasted state and blood will be drawn for measurement of glucose and insulin.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants receive insulin delivered continuously or every five minutes during the hyperinsulinemic euglycemic clamp test
| Arm | Type | Receives |
|---|---|---|
| Continuous insulin at 40mU/m2/min | Active comparator | Other: Continuous Insulin administration during hyperinsulinemic euglycemic clamp testParicipants will receive insulin infused continuously during the hyperinsulinemic euglycemic clamp test of insulin sensitivity. |
| Pulsatile insulin at 40mU/m2/min | Experimental | Other: Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp testParticipants will receive insulin infused every five minutes during the hyperinsulinemic euglycemic clamp test of insulin sensitivity |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completion of the Motivate Study (NCT05649176)
Key exclusion criteria (1 listed)
- Non-completion of the end-of-study hyperinsulinemic euglycemic clamp test of the Motivate 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 |
|---|---|---|
| Continuous Insulin administration during hyperinsulinemic euglycemic clamp testParticipants will receive insulin delivered continuously during the hyperinsulinemic euglycemic clamp test | Other | Continuous insulin at 40mU/m2/min |
| Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp testParticipants will receive insulin delivered every five minutes during the hyperinsulinemic euglycemic clamp test | Other | Pulsatile insulin at 40mU/m2/min |
Primary outcome
Insulin sensitivity
Time frame: One day
Glucose infusion rate during the hyperinsulinemic euglycemic clamp test
1 secondary outcome
Insulin resistance
Time frame: 24 hours
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 4 Sep 2026.
- Background: PubMed 37580916Rebello CJ, Morales TS, Chuon K, Dong S, Lam VT, Purner D, Lewis S, Lakey J, Beyl RA, Greenway FL. Physiologic hormone administration improves HbA1C in Native Americans with type 2 diabetes: A retrospective study and review of insulin secretion and action. Obes Rev. 2023 Dec;24(12):e13625. doi: 10.1111/obr.13625. Epub 2023 Aug 14.
- Individual participant dataSharing planned: No
Related trials for Insulin Sensitivity
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Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
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Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
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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.
Candida Rebello, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Insulin administration during hyperinsulinemic euglycemic clamp test and Pulsatile Insulin administration during hyperinsulinemic euglycemic clamp test in people with Insulin Sensitivity, 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 1 inclusion and 1 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 4 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?
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?
Insulin sensitivity (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06216665, which also lists 1 linked publication.
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 4 Sep 2026.