Type1diabetesNCT02984514
Brown Adipose Tissue in Type 1 Diabetes
A study testing Positron emission tomography with tracer 18F-deoxy glucose in people with Type1diabetes, run by Per-Ola Carlsson at 1 site in Sweden.
Trial summary
Brown adipose tissue has the capacity to consume large amounts of energy and has insulin-independent glucose uptake. The investigators have recently observed an inverse correlation between irisin levels and insulin needs of type 1 diabetes patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Positron emission tomography with tracer 18F-deoxy glucose
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2015to Jun 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years of age or more)
- Type 1 diabetes diagnose for more than 10 years
Who cannot join
- Ongoing pregnancy
- Ongoing breast-feeding
- BMI<19
- BMI >30
- P-creatinine <110 µmol/l
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studies of Activity of Brown Adipose Tissue With Positron Emission Tomography Using the Tracer 18F-deoxy Glucose in Patients With Type 1 Diabetes
Brown adipose tissue has the capacity to consume large amounts of energy and has insulin-independent glucose uptake. The investigators have recently observed an inverse correlation between irisin levels and insulin needs of type 1 diabetes patients. Transplantation of brown adipose tissue to insulin-deficient rats normalized their blood glucose levels.
In this study 12 patients with long-standing type 1 diabetes (>10 years) and with variable exogenous insulin needs will be investigated for amount of brown adipose tissue with positron emission tomography using the tracer 18F-deoxy glucose.
- Conditions
- Type1diabetes
- Being tested
- Positron emission tomography with tracer 18F-deoxy glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron emission tomography with tracer 18F-deoxy glucoseRadiation
Assessment of activity of brown adipose tissue with positron emission tomography using the tracer 18F-deoxy glucose
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes | Experimental | Positron emission tomography with tracer 18F-deoxy glucose Receives: Radiation: Positron emission tomography with tracer 18F-deoxy glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity of brown adipose tissue in correlation to exogenous insulin needs using the tracer 18F-deoxy glucose in positron emission tomography measurements
Measured: Assessment performed after more than 10 years of diagnosed type 1 diabetes
Secondary outcomes (1)
Glucose uptake in muscle in correlation to exogenous insulin needs; assessment using the tracer 18F deoxy glucose in positron emission tomography measurements.
Measured: Assessment performed after more than 10 years of diagnosed type 1 diabetes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startOct 2015
- Primary completionJan 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per-Ola Carlsson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Per-Ola Carlsson, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984514
- Sponsor's protocol ID
- Dnr 2015/191
- Status last verified
- Oct 2018
- First submitted
- 30 Nov 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Activity of Brown Adipose Tissue With Positron Emission Tomography Using the Tracer 18F-deoxy Glucose in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02984514
- Acronym / sponsor ID
- Dnr 2015/191
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Per-Ola CarlssonUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 7 Dec 2016 (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.
Brown adipose tissue has the capacity to consume large amounts of energy and has insulin-independent glucose uptake. The investigators have recently observed an inverse correlation between irisin levels and insulin needs of type 1 diabetes patients. Transplantation of brown adipose tissue to insulin-deficient rats normalized their blood glucose levels.
In this study 12 patients with long-standing type 1 diabetes (>10 years) and with variable exogenous insulin needs will be investigated for amount of brown adipose tissue with positron emission tomography using the tracer 18F-deoxy glucose.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes | Experimental | Radiation: Positron emission tomography with tracer 18F-deoxy glucosePositron emission tomography with tracer 18F-deoxy glucose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (18 years of age or more)
- Type 1 diabetes diagnose for more than 10 years
Key exclusion criteria (5 listed)
- Ongoing pregnancy
- Ongoing breast-feeding
- BMI<19
- BMI >30
- P-creatinine <110 µmol/l
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 |
|---|---|---|
| Positron emission tomography with tracer 18F-deoxy glucoseAssessment of activity of brown adipose tissue with positron emission tomography using the tracer 18F-deoxy glucose | Radiation | Type 1 diabetes |
Primary outcome
Activity of brown adipose tissue in correlation to exogenous insulin needs using the tracer 18F-deoxy glucose in positron emission tomography measurements
Time frame: Assessment performed after more than 10 years of diagnosed type 1 diabetes
1 secondary outcome
Glucose uptake in muscle in correlation to exogenous insulin needs; assessment using the tracer 18F deoxy glucose in positron emission tomography measurements.
Time frame: Assessment performed after more than 10 years of diagnosed type 1 diabetes
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 11 Oct 2018.
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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?
A study testing Positron emission tomography with tracer 18F-deoxy glucose in people with Type1diabetes, run by Per-Ola Carlsson at 1 site in Sweden.
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 2 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 11 Oct 2018. 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 Sweden. 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?
Activity of brown adipose tissue in correlation to exogenous insulin needs using the tracer 18F-deoxy glucose in positron emission tomography measurements (time frame: Assessment performed after more than 10 years of diagnosed type 1 diabetes). 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 11 Oct 2018.