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Brown Adipose Tissue in Type 1 Diabetes

Primary Purpose

Type1diabetes

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Positron emission tomography with tracer 18F-deoxy glucose
Sponsored by
Per-Ola Carlsson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type1diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Ongoing pregnancy
  2. Ongoing breast-feeding
  3. BMI<19
  4. BMI >30
  5. P-creatinine <110 µmol/l

Sites / Locations

  • Uppsala University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Type 1 diabetes

Arm Description

Positron emission tomography with tracer 18F-deoxy glucose

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Glucose uptake in muscle in correlation to exogenous insulin needs; assessment using the tracer 18F deoxy glucose in positron emission tomography measurements.

Full Information

First Posted
November 30, 2016
Last Updated
October 10, 2018
Sponsor
Per-Ola Carlsson
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1. Study Identification

Unique Protocol Identification Number
NCT02984514
Brief Title
Brown Adipose Tissue in Type 1 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Per-Ola Carlsson

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Type 1 diabetes
Arm Type
Experimental
Arm Description
Positron emission tomography with tracer 18F-deoxy glucose
Intervention Type
Radiation
Intervention Name(s)
Positron emission tomography with tracer 18F-deoxy glucose
Intervention Description
Assessment of activity of brown adipose tissue with positron emission tomography using the tracer 18F-deoxy glucose
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (18 years of age or more) Type 1 diabetes diagnose for more than 10 years Exclusion Criteria: Ongoing pregnancy Ongoing breast-feeding BMI<19 BMI >30 P-creatinine <110 µmol/l
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
751 23
Country
Sweden

12. IPD Sharing Statement

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Brown Adipose Tissue in Type 1 Diabetes

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