Type 2 DiabetesNCT01416649
Impact of Exenatide on Sleep Duration
An observational study of Type 2 Diabetes, run by University of Chicago at 1 site in United States.
Trial summary
This study investigates the effect of exenatide, a FDA approved medication for the treatment of type 2 diabetes on sleep duration and quality. Individuals with type 2 diabetes will be studied before and during treatment with Exenatide. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Exenatide
- Type of treatment
- Injection or infusion
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2011to 21 Apr 2021
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Convenience Sample
Who may be able to join
- Patients taking diabetes medications other then insulin will be included, but changes to their medications may be made as deemed necessary by their physician. Patients on stable medications for chronic and co-morbid conditions (high blood pressure, high cholesterol, etc) will be eligible
Who cannot join
- Patients with moderate or severe kidney disease and history of pancreatitis or patients on insulin will be excluded, as Exenatide use is contraindicated or risky in these conditions.
- Patients with unstable cardiac, neurological or psychiatric disease and women who are pregnant or trying to get pregnant will be excluded. Patients who have severe COPD, severe neuropathy or chronic pain, which could impair sleep, will be excluded. Shift workers will be also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Exenatide on Sleep Duration and Quality in Type 2 Diabetes
This study investigates the effect of exenatide, a FDA approved medication for the treatment of type 2 diabetes on sleep duration and quality. Individuals with type 2 diabetes will be studied before and during treatment with Exenatide.
Enrolled individuals will be asked to come to the University of Chicago for 3-4 outpatient visits over the course of 3-4 months.
- Conditions
- Type 2 Diabetes
- Being tested
- Exenatide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called The brand name of exenatide is Byetta.
Exenatide is started for the treatment of type 2 diabetes as determined by the patients regular physician. The dose will be 5-10 micrograms twice daily which is the standard dose. The medication is given by self-administered subcutaneous injection. The medication may continue for the treatment of the type 2 diabetes after the study is completed after 3 months.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep duration and sleep efficiency
Sleep duration and efficiency will be measured using an activity monitor worn on the wrist.
Measured: at the end of 3 months of treatment with the medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study start1 Feb 2011
- Primary completion21 Apr 2021
- Study completion21 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvana Pannain, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416649
- Sponsor's protocol ID
- 10-051-A
- Status last verified
- Apr 2023
- First submitted
- 11 Aug 2011
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exenatide on Sleep Duration and Quality in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01416649
- Acronym / sponsor ID
- 10-051-A
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Feb 2011 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 15 Aug 2011 (estimated)
- 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.
This study investigates the effect of exenatide, a FDA approved medication for the treatment of type 2 diabetes on sleep duration and quality. Individuals with type 2 diabetes will be studied before and during treatment with Exenatide.
Enrolled individuals will be asked to come to the University of Chicago for 3-4 outpatient visits over the course of 3-4 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Convenience Sample
Key inclusion criteria (1 listed)
- Patients taking diabetes medications other then insulin will be included, but changes to their medications may be made as deemed necessary by their physician. Patients on stable medications for chronic and co-morbid conditions (high blood pressure, high cholesterol, etc) will be eligible
Key exclusion criteria (2 listed)
- Patients with moderate or severe kidney disease and history of pancreatitis or patients on insulin will be excluded, as Exenatide use is contraindicated or risky in these conditions.
- Patients with unstable cardiac, neurological or psychiatric disease and women who are pregnant or trying to get pregnant will be excluded. Patients who have severe COPD, severe neuropathy or chronic pain, which could impair sleep, will be excluded. Shift workers will be also excluded.
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 |
|---|---|---|
| ExenatideAlso: The brand name of exenatide is Byetta.Exenatide is started for the treatment of type 2 diabetes as determined by the patients regular physician. The dose will be 5-10 micrograms twice daily which is the standard dose. The medication is given by self-administered subcutaneous injection. The medication may continue for the treatment of the type 2 diabetes after the study is completed after 3 months. | Drug | – |
Primary outcome
Sleep duration and sleep efficiency
Time frame: at the end of 3 months of treatment with the medication
Sleep duration and efficiency will be measured using an activity monitor worn on the wrist.
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 26 Apr 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.
Silvana Pannain, MD principal investigator
University of Chicago
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 Type 2 Diabetes, run by University of Chicago 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 2 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 26 Apr 2023. 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?
Sleep duration and sleep efficiency (time frame: at the end of 3 months of treatment with the medication). 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 26 Apr 2023.