Type 2 Diabetes MellitusNCT02563834
A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism
A study testing thiapalmitate tracer, Saline and Insulin in people with Type 2 Diabetes Mellitus, run by Indiana University at 1 site in United States.
Trial summary
Studies of myocardial fuel selection using a novel palmitate-based PET probe Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- thiapalmitate tracer, Saline and Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2009
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Lean:
- BMI<25 kg/m2
- normal glucose tolerance by 75g oral glucose tolerance test
- Type 2 diabetes mellitus:
- BMI >25 kg/m2
- previously diagnosed type 2 diabetes mellitus
- on oral and/or injected insulin treatment.
Who cannot join
- Lean:
- Use of any chronic medications
- Type 2 diabetes mellitus
- known microvascular disease
- known coronary or other macro vascular disease
- use of PPARgamma class antidiabetic agents within 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital GCRC
Indianapolis, Indiana, 46202
About this study
Studies of myocardial fuel selection using a novel palmitate-based PET probe
Read the detailed description
A novel Positron Emission Tomography (PET) probe, 16- 18-F-fluoro-4-thiapalmitate, will be used to evaluate myocardial atty acid uptake. Studies will be done in humans with type 2 diabetes mellitus, and in controls. Studies will take place on 2 separate days, under fasting conditions and under insulin clamp conditions.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- thiapalmitate tracer, Saline, Insulin
- 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.
thiapalmitate tracerDrug
Also called 16- 18-F-fluoro-4-thiapalmitate
Radiolabeled tracer infusion; occurs in all treatment arms
SalineDrug
Saline infusion for control
InsulinDrug
Insulin infusion for insulin/glucose clamp procedure
| Study group | Role | What they receive |
|---|---|---|
| Saline | Experimental | Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate). Receives: Drug: thiapalmitate tracer; Drug: Saline |
| Insulin Clamp | Experimental | Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate). Receives: Drug: thiapalmitate tracer; Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Fatty Acid Uptake Rate
PET measure of fatty acid uptake rate
Measured: 4 Hours
Secondary outcomes (2)
Myocardial Oxidation Rate
PET measure of total oxidation rate
Measured: 4 Hours
Myocardial Perfusion Rate
PET measure of total myocardial perfusion (blood flow)
Measured: 4 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startJan 2007
- Primary completionJun 2009
- Study completionJun 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kieren J Mather, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563834
- Sponsor's protocol ID
- 10100002643
- Other IDs
- R21DK071142
- Status last verified
- Aug 2016
- First submitted
- 29 Sep 2015
- Last updated
- 31 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mather KJ, Hutchins GD, Perry K, Territo W, Chisholm R, Acton A, Glick-Wilson B, Considine RV, Moberly S, DeGrado TR. Assessment of myocardial metabolic flexibility and work efficiency in human type 2 diabetes using 16-[18F]fluoro-4-thiapalmitate, a novel PET fatty acid tracer. Am J Physiol Endocrinol Metab. 2016 Mar 15;310(6):E452-60. doi: 10.1152/ajpendo.00437.2015. Epub 2016 Jan 5.
PubMed 26732686
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism
- ClinicalTrials.gov ID
- NCT02563834
- Acronym / sponsor ID
- 10100002643
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Posted 31 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studies of myocardial fuel selection using a novel palmitate-based PET probe
Detailed description
A novel Positron Emission Tomography (PET) probe, 16- 18-F-fluoro-4-thiapalmitate, will be used to evaluate myocardial atty acid uptake. Studies will be done in humans with type 2 diabetes mellitus, and in controls. Studies will take place on 2 separate days, under fasting conditions and under insulin clamp conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Experimental | Drug: thiapalmitate tracer, Drug: SalineStudies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate). |
| Insulin Clamp | Experimental | Drug: thiapalmitate tracer, Drug: InsulinStudies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Lean:
- Type 2 diabetes mellitus:
Key exclusion criteria (6 listed)
- Lean:
- Use of any chronic medications
- Type 2 diabetes mellitus
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 |
|---|---|---|
| thiapalmitate tracerAlso: 16- 18-F-fluoro-4-thiapalmitateRadiolabeled tracer infusion; occurs in all treatment arms | Drug | Insulin Clamp, Saline |
| SalineSaline infusion for control | Drug | Saline |
| InsulinInsulin infusion for insulin/glucose clamp procedure | Drug | Insulin Clamp |
Primary outcome
Myocardial Fatty Acid Uptake Rate
Time frame: 4 Hours
PET measure of fatty acid uptake rate
2 secondary outcomes
Myocardial Oxidation Rate
Time frame: 4 Hours
Myocardial Perfusion Rate
Time frame: 4 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26732686Mather KJ, Hutchins GD, Perry K, Territo W, Chisholm R, Acton A, Glick-Wilson B, Considine RV, Moberly S, DeGrado TR. Assessment of myocardial metabolic flexibility and work efficiency in human type 2 diabetes using 16-[18F]fluoro-4-thiapalmitate, a novel PET fatty acid tracer. Am J Physiol Endocrinol Metab. 2016 Mar 15;310(6):E452-60. doi: 10.1152/ajpendo.00437.2015. Epub 2016 Jan 5.
- Individual participant dataSharing planned: No
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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.
Kieren J Mather, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thiapalmitate tracer, Saline and Insulin in people with Type 2 Diabetes Mellitus, run by Indiana University 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 7 inclusion and 6 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 31 Aug 2016. 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 31 Aug 2016). 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?
Myocardial Fatty Acid Uptake Rate (time frame: 4 Hours). 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 NCT02563834, 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 31 Aug 2016.