Insulin SensitivityNCT01546545
Insulin Variance Throughout the Day
An observational study of Insulin Sensitivity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This study is designed to determine whether the sensitivity of a participant's insulin varies from the morning to the evening. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to May 2013
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy participants with blood sugar between normal and diabetes.
Who may be able to join
- Are a healthy male or female
- Have a fasting blood sugar that is between normal and diabetes.
- Are between 18 and 70 years of age, inclusive.
Who cannot join
- Are pregnant or breast-feeding a child
- Take a medication for diabetes
- Take a medication like cortisone that can change your blood sugar.
- Take a medication chronically that has not been at a stable dose for at least 1 month
- Take medication for psychosis that is known to change timing in the day - night cycle
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Testing Whether Insulin Resistance Varies Throughout a Day A Pilot Study
This study is designed to determine whether the sensitivity of a participant's insulin varies from the morning to the evening.
Read the detailed description
Study visit 1: about 16 hours - The participant will arrive to the visit fasting.
The participant will have an oral glucose tolerance test which takes about 3 ½ hours.
An IV line will be placed in the participant's arm vein for blood draw purposes and will remain there throughout the testing. A blood sample will be drawn 15 minutes and just before the participant will drink a sugar solution consisting of 75 grams of glucose. Blood will be drawn at specific times after the participant consumes the drink.
The participant will have a second oral glucose tolerance test which takes about 3 ½ hours. An IV line will be placed in the participant's arm vein for blood draw purposes and will remain there throughout the testing. A blood sample will be drawn 15 minutes and just before the participant drinks a sugar solution. Blood will be drawn at specific times after the participant consumes the drink.
- Conditions
- Insulin Sensitivity
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Insulin Sensitivity in Pre-Diabetic Population | Healthy participants between the age of 18 and 70 years with fasting blood sugar that is between normal and diabetes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Glucose Tolerance Between Morning at 7:00 AM and Evening at 7:00 PM
This study designed to determine whether glucose tolerance varies from the morning to the evening. The test is useful in the diagnosis of diabetes and pre diabetes. Oral Glucose Tolerance Testing (OGTT) provides details about how quickly glucose is absorbed into the bloodstream for use by body cells as energy. The rate of glucose clearance depends on the amount of glucose consumed and insulin levels. Once the participant drink a glucose-rich beverage, blood will be drawn at two and three hour points, and tested to see how effective the body metabolizes blood glucose.
Measured: 24 hours
Difference Between Morning at 7:00 AM and Evening at 7:00 PM 2-hour AUC Insulin Levels During an OGTT
This study designed to determine whether insulin levels vary from the morning at 7:00 AM to the evening at 7:00 PM. The test is useful in the diagnosis of diabetes and pre diabetes. Oral Glucose Tolerance Testing (OGTT) provides details about how quickly glucose is absorbed into the bloodstream for use by body cells as energy. The rate of glucose clearance depends on the amount of glucose consumed and the amount of insulin in the body. Once the participant drink a glucose-rich beverage, blood will be drawn at two and three hour points, and tested to see how effective the body metabolizes blood glucose.
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 posted7 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2013
- Study completionMay 2013
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 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jenny Craig, Inc.
- Responsible party
- Sponsor
- Investigators
- Jeffrey Gimble, MD, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546545
- Sponsor's protocol ID
- PBRC 11021
- Status last verified
- Aug 2023
- First submitted
- 24 Feb 2012
- Last updated
- 7 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Whether Insulin Resistance Varies Throughout a Day A Pilot Study
- ClinicalTrials.gov ID
- NCT01546545
- Acronym / sponsor ID
- PBRC 11021
- Conditions
- Insulin Sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Jenny Craig, Inc.
- Study start
- Mar 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Posted 7 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine whether the sensitivity of a participant's insulin varies from the morning to the evening.
Detailed description
Study visit 1: about 16 hours - The participant will arrive to the visit fasting.
The participant will have an oral glucose tolerance test which takes about 3 ½ hours.
An IV line will be placed in the participant's arm vein for blood draw purposes and will remain there throughout the testing. A blood sample will be drawn 15 minutes and just before the participant will drink a sugar solution consisting of 75 grams of glucose. Blood will be drawn at specific times after the participant consumes the drink.
The participant will have a second oral glucose tolerance test which takes about 3 ½ hours. An IV line will be placed in the participant's arm vein for blood draw purposes and will remain there throughout the testing. A blood sample will be drawn 15 minutes and just before the participant drinks a sugar solution. Blood will be drawn at specific times after the participant consumes the drink.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin Sensitivity in Pre-Diabetic Population | – | –Healthy participants between the age of 18 and 70 years with fasting blood sugar that is between normal and diabetes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participants with blood sugar between normal and diabetes.
Key inclusion criteria (3 listed)
- Are a healthy male or female
- Have a fasting blood sugar that is between normal and diabetes.
- Are between 18 and 70 years of age, inclusive.
Key exclusion criteria (5 listed)
- Are pregnant or breast-feeding a child
- Take a medication for diabetes
- Take a medication like cortisone that can change your blood sugar.
- Take a medication chronically that has not been at a stable dose for at least 1 month
- Take medication for psychosis that is known to change timing in the day - night cycle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in Glucose Tolerance Between Morning at 7:00 AM and Evening at 7:00 PM
Time frame: 24 hours
This study designed to determine whether glucose tolerance varies from the morning to the evening. The test is useful in the diagnosis of diabetes and pre diabetes. Oral Glucose Tolerance Testing (OGTT) provides details about how quickly glucose is absorbed into the bloodstream for use by body cells as energy. The rate of glucose clearance depends on the amount of glucose consumed and insulin levels. Once the participant drink a glucose-rich beverage, blood will be drawn at two and three hour points, and tested to see how effective the body metabolizes blood glucose.
Difference Between Morning at 7:00 AM and Evening at 7:00 PM 2-hour AUC Insulin Levels During an OGTT
Time frame: 24 hours
This study designed to determine whether insulin levels vary from the morning at 7:00 AM to the evening at 7:00 PM. The test is useful in the diagnosis of diabetes and pre diabetes. Oral Glucose Tolerance Testing (OGTT) provides details about how quickly glucose is absorbed into the bloodstream for use by body cells as energy. The rate of glucose clearance depends on the amount of glucose consumed and the amount of insulin in the body. Once the participant drink a glucose-rich beverage, blood will be drawn at two and three hour points, and tested to see how effective the body metabolizes blood glucose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- 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.
Jeffrey Gimble, MD, 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?
An observational study of 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 3 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 7 Mar 2024. 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 7 Mar 2024). 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?
Difference in Glucose Tolerance Between Morning at 7:00 AM and Evening at 7:00 PM (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 7 Mar 2024.