NCT02984514

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

2.3 years

First QC Date

November 30, 2016

Last Update Submit

October 10, 2018

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

  • Activity of brown adipose tissue in correlation to exogenous insulin needs using the tracer 18F-deoxy glucose in positron emission tomography measurements

    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.

    Assessment performed after more than 10 years of diagnosed type 1 diabetes

Study Arms (1)

Type 1 diabetes

EXPERIMENTAL

Positron emission tomography with tracer 18F-deoxy glucose

Radiation: Positron emission tomography with tracer 18F-deoxy glucose

Interventions

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

Type 1 diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (18 years of age or more)
  • Type 1 diabetes diagnose for more than 10 years

You may not qualify if:

  • Ongoing pregnancy
  • Ongoing breast-feeding
  • BMI\<19
  • BMI \>30
  • P-creatinine \<110 µmol/l

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital

Uppsala, 751 23, Sweden

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Senior consultant

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 7, 2016

Study Start

October 1, 2015

Primary Completion

January 1, 2018

Study Completion

June 1, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations

SE(1)